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First-in-human study of Protaryx transseptal puncture technology completed
Protaryx Medical has announced the completion of its first-in-human (FIH) study, assessing its advanced transseptal puncture technology.
Conducted on 3 December 2024 at Sanatorio Italiano...
AHA 2024: Five-year Amulet IDE data show similar outcomes with Amplatzer...
Latest data from the Amulet investigational device exemption (IDE) trial, comparing the Amplatzer Amulet (Abbott) left atrial appendage occluder (LAAO) to the first-generation Watchman...
First patient enrolled in trial of Cysoni temporary pacing technology
Ceryx Medical has announced that the first patient has been enrolled in the RSA-Pace multicentre study at Waikato Hospital in Hamilton, New Zealand evaluating...
AHA 2024: OPTION trial reports positive outcomes for Watchman FLX at...
Three-year results from the OPTION clinical trial, comparing the Watchman FLX (Boston Scientific) left atrial appendage closure (LAAC) system to oral anticoagulation for stroke...
Medtronic receives US FDA approval of Affera mapping and ablation system...
Medtronic has announced US Food and Drug Administration (FDA) approval of the Affera mapping and ablation system with Sphere-9 catheter, an all-in-one, high-density (HD)...
NICE recommends use of HeartLogic heart failure diagnostic
Boston Scientific has announced that the National Institute for Health and Care Excellence (NICE), has issued guidance recommending the use of the HeartLogic heart...
GLACE study to assess ICE imaging during LAA closure
Conformal Medical has announced the initiation of the GLACE Study, assessing the use of intracardiac echocardiography (ICE) imaging of the left atrial appendage (LAA)...
ESC 2024: Remote echocardiograms offer “relatively good diagnostic accuracy”
Research presented at the 2024 European Society of Cardiology (ESC) congress (30 August–2 September, London, UK) will show that performing echocardiograms remotely using a...
First patient treated with AtriClip FLEX-Mini LAA device
AtriCure has announced that the first patient has been treated with the AtriClip FLEX-Mini left atrial appendage (LAA) exclusion device, which recently received US...
Omny-IRE clinical trial completes enrolment
Biosense Webster has announced the enrolment completion of the Omny-IRE clinical trial.
Omny-IRE is a prospective, multicentre, non-randomised clinical trial that enrolled 188 patients in...
AtriClip LAA device receives expanded indication
AtriCure has received an expanded indication for the AtriClip left atrial appendage (LAA) exclusion system in CE-marked countries in Europe.
The product is now indicated...
BioCardia submits 510(k) approval for Morph DNA steerable introducer sheath family
BioCardia has submitted a 510(k) for approval of its patented Morph DNA steerable introducer sheath to the US Food and Drug Administration (FDA).
This product...
FibriCheck remote arrhythmia detection system gains US FDA clearance
FibriCheck—a smartphone or smartwatch app capable of measuring a patient’s heart rhythm and detecting possible arrhythmias—has been cleared by the US Food and Drug...
AtriClip LAA exclusion system granted approval for marketing in China
AtriCure has received regulatory approval from the National Medical Products Administration (NMPA) of China to market and sell several models of its AtriClip left...
RSA-pace study of Cysoni-XT temporary pacing system granted approval
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Ceryx Medical’s clinical trial authorisation application for the pilot respiratory sinus arrhythmia (RSA)-pace...
Royal Brompton Hospital installs UK’s first Magnetom Cima.X MRI system
Royal Brompton Hospital, part of Guy’s and St Thomas’ NHS Foundation Trust (London, UK) has become the first hospital in the UK to install...
Consumer wearables found to have clinical value in assessing treatment for...
Monitoring of heart rate and physical activity using consumer wearable devices was found to have clinical value for comparing the response to two treatments...
First US heart failure patient receives V-LAP left atrial pressure sensor
A patient in Cincinnati has become the first in the USA to receive a system that enables remote monitoring of his heart and congestion...
Advertorial: PFA is now “beyond the phase of excitement”
This advertorial is sponsored by Boston Scientific
The arrival of pulsed-field ablation (PFA) has been heralded by many experts in the field of arrhythmia management...
Advertorial: AFib Symposium 2024: Cutting-edge science and practical sessions offer glimpse...
This advertorial is sponsored by Biosense Webster
Biosense Webster founded the AFib Symposium in 2002. Now in its 22nd year, the annual event combines practical...
Global Cardiovascular Awards return in 2025
Entries have opened for the second edition of the Global Cardiovascular Awards, celebrating innovation and excellence in the field of cardiovascular healthcare.
Returning on 13...
Adona Medical secures financing to initiate clinical use of interatrial shunt...
Adona Medical has secured US$33.5 million in Series C financing, with the money to be used to further product development and initiate clinical use...
MANIFEST-17k registry shows promising safety performance for PFA
Pulsed field ablation (PFA) is safe for treating patients with common types of atrial fibrillation (AF), findings of the largest real-world registry of the...
Medtech insight: Trial pipeline underpins growth strategy for Watchman LAAC device
Investment in a programme of clinical trials will underpin Boston Scientific’s strategy to expand the uptake of its Watchman left atrial appendage closure (LAAC)...
Kardium closes latest round of financing
Kardium, developer of the Globe mapping and ablation system for the treatment of atrial fibrillation (AF), has raised US$104 million in a new financing...
Abbott receives CE mark for Aveir dual chamber leadless pacemaker system
Abbott has received CE mark in Europe for the Aveir dual chamber (DR) leadless pacemaker system.
The Aveir DR leadless pacemaker system utilises a new...
HRS 2024: SPHERE Per-AF results hold promise for Medtronic’s Sphere-9 catheter
Results of the SPHERE Per-AF study, investigating the safety and efficacy of Medtronic’s Sphere-9 catheter, have been presented at the Heart Rhythm Society (HRS)...
HRS 2024: Small diameter defibrillation lead meets safety and effectiveness endpoints...
Medtronic has announced that its investigational OmniaSecure defibrillation lead met its primary safety and effectiveness endpoints, exceeding prespecified performance goals in the global LEADR...
HRS 2024: FARADISE registry “underscores” safety and efficacy of Farapulse PFA...
Insights from the FARADISE registry, studying real-world outcomes from more than 1,000 patients to have undergone catheter ablation for paroxysmal and non-paroxysmal atrial fibrillation...
Mediterranean diet reduces risk of arrhythmia recurrence after ablation for paroxysmal...
Patients with previous paroxysmal atrial fibrillation (AF) who follow a Mediterranean diet enriched with extra-virgin olive oil after a catheter ablation procedure saw improved...
HRS 2024: “Noteworthy” results from MODULAR ATP trial detail use of...
Six-month results from the ongoing pivotal MODULAR ATP clinical trial assessing the Boston Scientific’s mCRM modular cardiac rhythm management (CRM) system were presented at...
HRS 2024: Late-breaking data explore safety and efficacy of Varipulse PFA...
Late-breaking results from the pivotal phase of the admIRE pivotal clinical trial, alongside results from the VIRTUE study—both assessing the Varipulse (Biosense Webster) pulsed...
Hotwire RF guidewire system gains US FDA approval
Atraverse Medical has announced US Food and FDA clearance of its Hotwire radiofrequency (RF) guidewire, a novel device that enables zero exchange left-heart access...
Adagio Medical announces milestones for VT cryoablation system
Adagio Medical has announced the completion of the first commercial procedures using its recently CE marked ventricular tachycardia (VT) cryoablation system and the US...
Biosense Webster launches latest generation of its Carto 3 mapping system
Biosense Webster has announced the launch of the latest version of the its three-dimensional (3D) heart mapping system used in cardiac ablation procedures—Carto 3...
Two-year echocardiographic data from REDUCE LAP-HF II trial published in JAMA...
Corvia Medical has announced the publication of two-year echocardiographic data from its REDUCE LAP-HF II randomised clinical trial of the Corvia atrial shunt in...
Feasibility study completed using PFA combined with SERF ablation system for...
Thermedical, a developer of advanced thermal-ablation systems to treat ventricular arrhythmias, announced today that it has completed a feasibility study utilising pulsed field ablation...
EVERCOOL AF study of oesophageal cooling system enrols its first patient
Heart Rhythm Clinical and Research Solutions (HRCRS) and the Real World Evidence (RWE) Consortium have enrolled the first patient in the EVERCOOL AF study,...
ACC 2024: Interatrial shunt fails to meet primary endpoint in RELIEVE-HF...
Patients with heart failure who had an interatrial shunt inserted between the left and right atria did not see any significant benefits overall compared...
Biomonitor IV ICM receives CE mark approval
Biotronik has announced the CE mark approval and first European implant of its latest insertable cardiac monitor (ICM)—Biomonitor IV.
The device features artificial intelligence (AI)...
Early results of dual energy catheter system reported at EHRA 2024
Three-month follow-up results from the SmartfIRE clinical trial, investigating Biosense Webster’s Thermocool Smarttouch SF dual energy catheter were presented in a late-breaking trial session...
EHRA 2024: Closed loop stimulation rate-adaptive pacing may delay sub-clinical AF...
Clinical findings of the B3 study, assessing the impact of closed loop stimulation on the incidence of sub-clinical atrial fibrillation (AF) in sinus node...
EHRA 2024: Sphere-360 study reports first-in-man results of Medtronic PFA catheter
Interim first-in-human clinical safety and efficacy results for Medtronic’s Sphere-360 investigational single-shot mapping and ablation catheter using pulsed field (PF) energy, for treatment of...
EHRA 2024: Preventive ablation may hold promise for ventricular tachycardia
A randomised trial investigating preventive ablation of a potential arrhythmogenic substrate associated with coronary chronic total occlusion (CTO) in patients at high risk of...
EHRA 2024: Cryocure-VT trial results “promising” for VT ablation
A trial of technology using ultra-low temperature cryoablation (ULTC) has shown that the technique eliminated clinical ventricular tachycardia (VT) in 94% of patients.
The finding...
EHRA 2024: Societies update consensus statement on catheter or surgical ablation
An international consensus statement on how to treat atrial fibrillation (AF) with catheter or surgical ablation has been published today in EP Europace and...
Boston Scientific launches NAVIGATE-PF study
Boston Scientific has initiated the NAVIGATE-PF study of the Faraview software module when it is used to visualise and track the Farawave Nav pulsed...
ACC 2024: AEDs used in a small number of cardiac arrest...
Automated external defibrillators (AEDs) were used in in 13 of nearly 1,800 cases of out-of-hospital cardiac arrest, even though many of the incidents occurred...
AI software integrated into GE Healthcare’s Vscan Air SL handheld ultrasound...
GE HealthCare has announced the launch of Caption AI artificial intelligence (AI)-driven software for Vscan Air SL, its dual-headed, handheld, wireless, point-of-care ultrasound imaging...
PULSAR IDE trial completes enrolment of paroxysmal AF cohort
Kardium has announced the successful completion of enrolment in the paroxysmal cohort of the pivotal PULSAR IDE (investigational device exemption) study of the Globe...
High-power short-duration ablation protocol “reduces procedure times”
High-power short-duration ablation results in significantly shorter procedure times without affecting procedural efficacy and safety among patients undergoing ablation for atrial fibrillation (AF).
This is...
Biosense Webster submits premarket approval application to US FDA for Varipulse...
Biosense Webster has submitted a premarket approval application (PMA) to the US Food & Drug Administration (FDA) for its Varipulse platform. The submission was...
Adagio Medical’s ultra-low temperature cryoablation system gains CE mark for monomorphic...
Adagio Medical has announced CE mark approval of its ultra-low temperature cryoablation (ULTC) system for the treatment of monomorphic ventricular tachycardia.
The system consists of...
Assert-IQ insertable cardiac monitor gains CE mark
Abbott has announced it has received CE mark in Europe for its Assert-IQ insertable cardiac monitor (ICM).
Physicians can insert the Assert-IQ ICM under the...
Biotronik introduces “first” complete system for LBBAP
Following the recent CE approval of the Solia S lead for left bundle branch area pacing (LBBAP), Biotronik has announced the first complete conduction...
AFFECT-EU project underscores need for AF screening to prevent stroke
People at risk should be tested for atrial fibrillation (AF) every time they attend a health appointment, according to results of the AFFECT-EU project....
First patients enrolled in VALID-ECG study of HeartBeam AIMIGo system
HeartBeam has announced that it has enrolled the first patients in the VALID-ECG pivotal study. The first patients were enrolled at Atlanta Heart Specialists...
US FDA approves weight loss drug Wegovy to prevent cardiovascular events
The US Food and Drug Administration (FDA) has approved an additional indication for the weight loss drug semaglutide—marketed as Wegovy (Novo Nordisk) —to reduce...
Stereotaxis makes European and US regulatory submissions for MAGiC catheter
Stereotaxis has announced that regulatory submissions were made recently in both Europe and the USA for the MAGiC catheter. These submissions follow initial clinical...
Haemonetics to acquire Attune Medical
Haemonetics Corporation has entered into a definitive agreement to acquire Attune Medical, the manufacturer of the ensoETM proactive oesophageal cooling device, the only US...
PROACTIVE-HF pivotal trial of Cordella pulmonary artery sensor meets primary endpoints
Six-month results from the PROACTIVE-HF pivotal trial, evaluating the Cordella pulmonary artery (PA) sensor (Endotronix) in New York Heart Association (NYHA) class III heart...
Trial of autologous cell therapy in advanced chronic heart failure reports...
BioCardia has announced interim results from the phase III randomised controlled trial of its CardiAMP autologous cell therapy in 110 randomised patients with advanced...
AI-powered Volta AF-Xplorer software gains CE mark
Volta Medical has announced CE mark for its Volta AF-Xplorer, an artificial intelligence (AI) companion that is cleared in the USA for the real-time...
Varipulse PFA system receives CE mark
Biosense Webster has announced the receipt of European CE mark approval for the Varipulse platform for the treatment of symptomatic drug refractory recurrent paroxysmal...
Patient enrolment completed in study of remote heart failure monitoring device
FIRE1 today announced that it has completed patient enrolment in the US early feasibility study—FUTURE-HF2—of its FIRE1 system for remote heart failure monitoring.
The FIRE1...
AHA acknowledges potential and pitfalls for AI in cardiovascular medicine
A scientific statement published by the American Heart Association (AHA) in Circulation today acknowledges the potential “transformative” impact of the technology on cardiovascular...
AI analysis of ECG patterns can predict sudden cardiac arrest
Researchers have detailed how artificial intelligence (AI) can be used to predict sudden cardiac arrest by studying patterns in electrocardiograms (ECGs) as well as...
First patient treated using A-Flux Reducer interventional system for angina
VahatiCor has announced the treatment of the first patient with the A-Flux Reducer system, an interventional treatment for patients with angina or chest pain.
The...
First cases using Laminar LAAX system performed as part of IDE...
Biosense Webster has announced the commencement of patient cases with the investigational Laminar left atrial appendage elimination (LAAX) system as part of its pivotal...
FineHeart files six international patents for FlowMaker implantable device
FineHeart has announced the successful filing of six new international patents for FlowMaker, a fully implantable device for the treatment of patients with advanced...
Australian government offers grant support to artificial heart programme
BiVACOR, a clinical-stage medical device company, has announced that US$13 million has been awarded from the Australian government’s Medical Research Future Fund (MRFF) grant...
Reprieve Cardiovascular secures multimillion dollar financing
Reprieve Cardiovascular, a development stage company focused on pioneering an automated diuretic and fluid management approach for acute decompensated heart failure (ADHF) treatment, announced...
US FDA approval for wearable electrophysiology monitoring system
X-trodes has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s Smart Skin solution, marketed as X-trodes...
Researchers detail impact of CPR timing on likelihood of survival after...
A person’s chance of surviving while receiving cardiopulmonary resuscitation (CPR) for cardiac arrest in hospital declines rapidly from 22% after one minute to less...
Sixty-day follow-up “positive” among AF patients treated with CellFX pulsed field...
Pulse Biosciences has announced favourable findings from the 60-day post-procedure evaluations for four initial patients treated in the Company’s CellFX nanosecond pulsed field ablation...
Advertorial: Arrival of PFA “may widen accessibility” of ablation for AF...
This advertorial is sponsored by Biosense Webster
The field of catheter ablation for atrial fibrillation (AF) is evolving. The development of pulsed field ablation (PFA),...
Biotronik announces it will solely supply proprietary DX models for new...
Biotronik has announced that it will solely supply the proprietary DX models for new single-chamber implantable cardioverter-defibrillators (ICDs) implants moving forward.
The move is being...
Biosense Webster supports VIRTUE and POLARIS studies of Varipulse PFA system
Biosense Webster has announced support for two collaborative studies, VIRTUE and POLARIS aiming to better understand the use and workflows with the investigational Varipulse...
ISC 2024: Data from STROKE AF study show cost effectiveness of...
Medtronic has announced new cost-effectiveness data from the STROKE AF clinical study, which showed that continuous monitoring with the Reveal LINQ insertable cardiac monitor...
AF Symposium hears late-breaking data on Varipulse PFA system
Twelve-month results from the inspIRE study, investigating predictors of success for pulmonary vein isolation with pulsed field ablation (PFA) using a variable loop catheter...
AF Symposium 2024: Posterior wall ablation does not benefit patients with...
Posterior wall ablation, a commonly used adjunct to pulmonary vein isolation (PVI), does not add any benefits for patients undergoing catheter ablation for persistent...
Non-pulmonary vein AF driver ablation guided by mapping software could improve...
Findings of an investigation into whether ablation of non-pulmonary vein atrial fibrillation (AF) drivers identified by machine learning in addition to pulmonary vein isolation...
AF Symposium 2024: AI-enabled predictive pre-planning “significantly improves LAAO procedural efficiency”
Data from the first US comprehensive single-centre experience at St Bernard’s Medical Center and Arrhythmia Research Group (Jonesboro, USA), presented at a late-breaking session...
Boston Scientific’s Farapulse PFA system gains US FDA approval
Boston Scientific has received US Food and Drug Administration (FDA) approval for the Farapulse pulsed field ablation (PFA) system.
The Farapulse PFA system is indicated...
Biotronik’s DX devices reach 100,000-patient milestone
Biotronik has announced the milestone achievement of 100,000 implanted single-chamber implantable cardioverter-defibrillators (ICDs) equipped with DX Technology.
Since the introduction of the technology in 2009,...
Element Science receives CE Mark for the Jewel patch-wearable cardioverter defibrillator
Element Science has announced that it has received CE mark certification and UK Conformity Assessed (UKCA) marking for its novel patch-wearable cardioverter defibrillator (P-WCD)...
See the full shortlist for the Global Cardiovascular Awards
The full shortlist for the inaugural Global Cardiovascular Awards—which will recognise the tireless work of individuals, teams and organisations to improve the life of...
Tributes paid following death of electrophysiology pioneer and former HRS president...
Tributes have poured in from across the world of cardiology following the death of Bruce Wilkoff, a pioneer of cardiac electrophysiology and former president...
Abbott joins the pulsed field ablation party
Abbott has announced the first global procedures have been conducted using the company’s new Volt pulsed field ablation (PFA) system to treat patients with...
“Structural heart leader” joins Cardiac Dimensions as chief medical officer
Cardiac Dimensions, a developer of invasive treatment modalities to address patients suffering from heart failure with functional mitral regurgitation (FMR), has announced that interventional...
Occlutech to launch atrial septal defect occluder in the USA
Occlutech has announced that the US Food and Drug Administration (FDA) has approved the Occlutech ASD Occluder and Occlutech Pistol Pusher for the treatment...
First patient randomised in BACKBEAT study of AVIM therapy for uncontrolled...
Orchestra BioMed Holdings has announced the first patient was randomised in the BACKBEAT pivotal study in late December 2023.
The BACKBEAT pivotal study will evaluate...
CardioFocus acquires Galvanize Therapeutics’ Electrophysiology Technology division
CardioFocus has announced the acquisition of Galvanize Therapeutics' Electrophysiology Technology division.
Notable assets included in the acquisition are the Centauri system pulsed electric field generator,...
Medical cannabis for chronic pain may increase risk of arrhythmia
People taking medical cannabis for chronic pain have a slightly increased risk of arrhythmia, according to research published in the European Heart Journal.
Recreational use...
Varipulse PFA platform granted approval by Japanese Ministry of Health
Biosense Webster has today announced approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the Varipulse platform for the treatment of...
GE HealthCare to acquire AI-imaging specialist
GE HealthCare has entered into an agreement to acquire MIM Software, a provider of artificial intelligence (AI)-enabled image analysis and workflow tools across multiple...
First patients treated with Stereotaxis’ robotically navigated magnetic ablation catheter
Stereotaxis has announced that the first patients have been successfully treated using its Magnetic Interventional Ablation Catheter, MAGiC.
Stereotaxis’ MAGiC catheter is a robotically navigated...
Medtronic’s latest generation Micra leadless pacemaker systems gain CE mark
Medtronic has received CE mark for its Micra AV2 and Micra VR2, the next generation of its miniature, leadless pacemakers.
Micra AV2 and Micra VR2,...
Endotronix submits premarket approval application to US FDA for Cordella pulmonary...
Endotronix has submitted a premarket approval (PMA) application for its Cordella pulmonary artery (PA) sensor system to the US Food and Drug Administration (FDA).
Cordella...
iRhythm receives CE mark for its latest generation Zio monitor system
iRhythm Technologies has announced that its long-term ambulatory cardiac monitor, the Zio monitor ECG system, has received CE mark certification under the European Union’s...
Pulse Biosciences files premarket US FDA 510(k) notification for its CellFX...
Pulse Biosciences has filed a premarket notification 510(k) to the US Food and Drug Administration (FDA) for its novel CellFX nanosecond pulsed field ablation...
Study shows no safety risk in allowing patients to eat prior...
Allowing patients to eat before elective cardiac catheterisation posed no safety risk and benefited patient satisfaction and overall care, research published in the American...
AVANT GUARD clinical trial of Farapulse PFA system begins
Boston Scientific has initiated the AVANT GUARD clinical trial to evaluate the safety and effectiveness of the Farapulse pulsed field ablation (PFA) system as...
Blood potassium monitor under development to benefit patients with chronic renal...
CardioRenal and CHU Grenoble Alpes have announced an innovation that allows chronically ill patients to measure their blood potassium levels autonomously and accurately.
The Tenor...
LUMA Vision secures US$22 million in financing
LUMA Vision, developer of a novel four-dimensional (4D) cardiac imaging and navigation platform, has announced a total of US$22 million in new financing for...
First patients treated with Thermocool Smarttouch SF catheter as part of...
Biosense Webster has announced the first patient cases with the investigational dual energy Thermocool Smarttouch SF catheter took place as part of the SmartPulse...
Cardiac Rhythm News’ top stories of 2023
Which stories captured the attention of the electrophysiology community across 2023? Read our summary of the trending stories from across the Cardiac Rhythm News...
Early use of mechanical support shows benefit for patients with AMI...
Results of the National Cardiogenic Shock Initiative—a single-arm multicentre study assessing the feasibility and effictiveness of utilising early mechanical circulatory support using the Impella...
COVID-19 infection increases arrhythmia risk, large Swedish registry study finds
Individuals infected with COVID-19 are also at an increased risk of suffering from cardiac arrhythmias, research published online in European Heart Journal Open has...
Wearables could be used as a detection tool for arrhythmias in...
Smartwatches can help physicians detect and diagnose irregular heart rhythms in children, research published online in Communications Medicine has shown.
The finding comes from a...
Medtronic’s PulseSelect PFA system gains US FDA approval
Medtronic has announced that the US Food and Drug Administration (FDA) has approved the PulseSelect pulsed field ablation (PFA) system for the treatment of...
CathVision launches ECGenius 3.1
CathVision has announced the launch of ECGenius 3.1, an advanced version of its ECGenius system software.
The new version improves workflow and streamlines processes to...
Mortality from cardiovascular disease continues to increase globally
Cardiovascular diseases, including ischaemic heart disease, stroke, heart failure, peripheral and aortic diseases, arrhythmias and valvular heart disease remain the leading global cause of...
Harlan M Krumholz named as JACC editor-in-chief
The cardiologist and researcher, Harlan M Krumholz (Yale School of Medicine, New Haven, USA), has been named editor-in-chief of the Journal of the American...
Medtronic launches Penditure left atrial appendage exclusion system in the USA
Medtronic has announced the launch of its Penditure left atrial appendage (LAA) exclusion system in the USA.
The Penditure LAA Exclusion System is an implantable...
First patients join pivotal trial of Aortix pump for treatment of...
Procyrion has announced the enrolment of the first patients in the company’s investigational device exemption (IDE) pivotal trial.
The DRAIN-HF study will evaluate the Aortix...
Catheter ablation for AF given greater emphasis in new AHA and...
The American College of Cardiology (ACC) and the American Heart Association (AHA), with several other medical associations, have issued new guidelines for the prevention...
Johnson & Johnson acquires Laminar
Johnson & Johnson MedTech has announced the completion of the acquisition of Laminar, a medical device company focused on eliminating the left atrial appendage...
Catheter Precision’s VIVO 3D mapping system secures reimbursement in NHS England’s...
Healthcare 21 (HC21) has gained national reimbursement for Catheter Precision’s VIVO 3D mapping system in the UK following it being granted inclusion in National...
First patient enrolled in RECOVER IV randomised trial of Impella in...
Abiomed has announced that the first patient in the world has been enrolled in the landmark RECOVER IV randomised controlled trial (RCT).
The on-label, two-arm...
LAAC-related ischaemic stroke “less severe and less fatal” than with DOACs...
Ischaemic strokes in atrial fibrillation (AF) patients are less often disabling or fatal if they have been treated with left atrial appendage closure procedure...
AF after mitral valve surgery “has a strong negative influence on...
The occurrence of atrial fibrillation (AF) after mitral valve surgery may be more harmful than previously thought, the authors of a research paper in...
PROFID EHRA trial enrols first patient
A clinical trial to challenge the routine implantation of a defibrillator in myocardial infarction (MI) survivors with heart failure has enrolled its first patient....
Pulse Biosciences submits US FDA premarket notification
Pulse Biosciences has announced the filing of a premarket notification 510(k) to the US Food and Drug Administration (FDA) for its novel CellFX nanosecond...
Medtronic’s PulseSelect PFA system and Nitron CryoConsole gain CE mark
Medtronic has received CE mark for the PulseSelect pulsed field ablation (PFA) system and the Nitron CryoConsole.
The PulseSelect system is designed to treat atrial...
Jewel IDE reports positive results for wearable cardioverter defibrillator
Element Science has announced the successful completion and presentation of the results of the Jewel investigational device exemption (IDE) study, assessing the Jewel patch-wearable...
ARIES trial shows LVAD patients who did not receive aspirin had...
Abbott has announced new late-breaking data that show advanced heart failure patients living with its HeartMate 3 left ventricular assist device (LVAD) who did...
Large registry confirms promising safety performance for PFA
Analysis of outcomes of more than 17,000 patients receiving pulsed field ablation (PFA) using the Farapulse (Boston Scientific) device reinforce the safety profile of...
AHA 2023: RCE Technologies wins Health Tech competition
RCE Technologies, the developer of a non-invasive, instant measurement of cardiac proteins was selected as the winner of the annual Health Tech competition at...
ARTESIA shows reduced rate of stroke and embolism in sub-clinical AF...
Use of apixaban in patients with sub-clinical atrial fibrillation (AF) resulted in a lower risk of stroke or systemic embolism than aspirin, but a...
SELECT trial shows cardiovascular risk reduction in non-diabetics taking semaglutide
Results of the SELECT clinical trial, presented at the American Heart Association’s 2023 Scientific Sessions (11–13 November, Philadelphia, USA), have shown that overweight or...
CONFORMAL EFS results shared out to one year at TCT 2023
Conformal Medical has announced positive one-year results from the company's CONFORMAL Early Feasibility Study (EFS).
William Gray (Lankenau Heart Institute, Wynnewood, USA) presented the Conformal...
No difference in outcomes for AF patients undergoing LAAO and TAVI...
Patients with atrial fibrillation (AF) undergoing a transcatheter aortic valve implantation (TAVI) at the same time as a left atrial appendage occlusion (LAAO) procedure...
Algorithm reduces AF alert burden in remote cardiac monitoring
Implicity has announced the results of a clinical study published in the Cardiovascular Digital Health Journal, reaffirming that its proprietary algorithm is highly effective...
MANIFEST-PF analysis shows no gender difference in PFA outcomes
Women with atrial fibrillation (AF) undergoing pulsed field ablation (PFA) have just as good outcomes as men according to a large-scale international study published...
Biosense Webster shares new Q-FFICIENCY study data
Biosense Webster has announced new findings from the Q-FFICIENCY study have been published in the Journal of Cardiovascular Electrophysiology, which the company says demonstrate...
Research on cardiac fibroblasts may have “profound impact” for management of...
A research article in the journal Science has found that fibroblasts—scar-forming cells that reside in the scar tissue of an injured heart—directly play a...
FEops HEARTguide LAA workflow integrated into TeraRecon software
FEops has entered into a partnership with ConcertAI’s TeraRecon for the commercialisation of FEops HEARTguide’s for left atrial appendage (LAA) occlusion workflow, with a...
US FDA grants IDE approval for PROACTIVE-HF 2 study of Cordella...
Endotronix has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) for a subsequent multicentre study, PROACTIVE-HF 2, which...
Advertorial: Milestone procedure underscores optimism for future of pulsed field ablation
This advertorial is sponsored by Boston Scientific
Physicians at Na Homolce Hospital (Prague, Czech Republic) have recently completed their 2,000th clinical case using the FARAPULSE...
Pulse Biosciences and CardioNXT to collaborate on nsPFA first-in-human study
Pulse Biosciences has announced a collaboration with CardioNXT, to support the company’s planned nanosecond pulsed field ablation (nsPFA) cardiac catheter first-in-human study focused on...
Boston Scientific launches LUX-Dx II+ ICM
Boston Scientific today launched the LUX-Dx II+ insertable cardiac monitor (ICM) system, describing it as a next-generation insertable monitor for long-term monitoring of arrhythmias...
US FDA approval for AI-powered left ejection fraction detection device
Anumana has announced US Food and Drug Administration (FDA) 510(k) clearance for ECG-AI LEF, a breakthrough artificial intelligence (AI)-powered medical device to detect low...
Advertorial: Prucka 3 with CardioLab digital recording system
This advertorial has been sponsored by GE HealthCare.
In this white paper Usman Siddiqui (Advent Health, Orlando, USA) discusses the reasons why the Prucka 3...
Oesophageal injuring during cardiac ablation reduced when using ensoETM system
Research published in JACC: Clinical Electrophysiology has found a significant reduction in the rate of atrioesophageal fistuals (AEFs) during cardiac ablation of the left...
ESC 2023: Analyses “support use of ICDs” for indicated patients
Medtronic has announced the results from two analyses demonstrating survival benefits and a reduction in life-threatening cardiac events with the use of implantable cardioverter...
TactiFlex ablation catheter used in first Canadian case
Abbott has announced that the company's TactiFlex ablation catheter has been used for the first time in Canada at the Foothills Medical Centre in...
“Second-generation” PFA catheter developer Field Medical closes seed round
Field Medical has closed its oversubscribed seed round with investments totalling US$14million.
The convertible note funding was led by private investors who were joined by...
AZALEA-TIMI 71 Phase 2 study ends early after “overwhelming” endpoint reduction
Anthos Therapeutics has announced that the AZALEA-TIMI 71 Phase 2 study has been stopped early due to an “overwhelming” reduction in the composite of...
First patients treated in Omny-IRE clinical trial of Omnypulse catheter
Biosense Webster has announced that the first cases have been performed using the investigational Omnypulse catheter as part of the Omny-IRE clinical trial. The...
AI analysis of DECAAF II trial finds younger patients may benefit...
Younger atrial fibrillation (AF) patients are most likely to benefit from more personalised, magntetic resonance imaging (MRI)-guided ablation, according to a new analysis of...
Switching to NOACs in frail AF patients associated with more bleeding...
Switching vitamin K antagonist (VKA) treatment to a non-vitamin K antagonist oral anticoagulant (NOAC) in frail elderly patients with atrial fibrillation (AF) is associated...
SmartCardia receives US FDA clearance for 7L monitoring patch
SmartCardia has received US Food and Drug Administration (FDA) clearance for its seven-lead real-time electrocardiogram (ECG) monitoring patch and cloud platform.
SmartCardia's 7L patch is...
First procedure performed in FULCRUM-VT study of ultra-low temperature cryoablation system
Adagio Medical has announced the first ultra-low temperature cryoablation (ULTC) procedure performed using the Adagio vCLAS catheter system in the USA as part of...
Attune Medical granted US FDA de novo marketing authorisation for ensoETM
Attune Medical has been granted de novo marketing authorisation from the US Food and Drug Administration (FDA) for its ensoETM device to reduce the...
Rigshospitalet physicians treat first patients with latest robotic ablation system
Stereotaxis has announced that physicians at Heart Centre Rigshospitalet of Copenhagen University Hospital successfully treated the first patients using Stereotaxis’ Genesis robotic magnetic navigation...
Vektor Medical launches vMap software enhancements
Vektor Medical has announced the release of a series of software enhancements to its AI-based non-invasive solution, vMap.
Designed to improve ablation outcomes and procedural...
Watchman FLX Pro gains US FDA approval
Boston Scientific has received US Food and Drug Administration (FDA) approval for the latest-generation Watchman FLX Pro left atrial appendage closure (LAAC) device.
The device,...
ESC 2023: AF ablation improves outcomes in end-stage heart failure patients
Atrial fibrillation (AF) ablation is associated with lower rates of death, urgent heart transplantation or left ventricular assist device (LVAD) implantation compared with medical...
Amvia Edge pacemaker gets first US implant
Biotronik has announced the first US implantation of the Amvia Edge pacemaker. The procedure was successfully completed by Raul Weiss at Mount Sinai Medical...
UK MHRA adds capacity for medical device certification
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has designated three new approved bodies to increase the country’s capacity to certify medical devices.
TÜV...
ESC 2023: ADVENT trial shows PFA is non-inferior to thermal ablation...
Results of the first randomised trial comparing pulsed field ablation (PFA) to thermal ablation for the treatment of paroxysmal atrial fibrillation (AF)—ADVENT—have shown that...
ESC 2023: GE Healthcare showcases latest-generation handheld ultrasound scanner and AF...
GE Healthcare has announced the launch of two new tools for the cardiology market, coinciding with the European Society of Cardiology (ESC) congress (25–28...
ESC 2023: Anticoagulation should not be used in patients with AHRE...
Oral anticoagulation in patients with atrial high rate episodes (AHRE) increases bleeding without reducing a composite outcome of stroke, systemic embolism or cardiovascular death.
This...
ESC 2023: Study finds link between fitness and incidence of AF...
Physical fitness is linked with a lower likelihood of developing atrial fibrillation (AF) and stroke, a study of more than 15,000 people, to be...
Bryan Williams joins BHF as research leader
The British Heart Foundation (BHF) has appointed research leader and NHS consultant physician Bryan Williams as its first chief scientific and medical officer.
Williams will...
Forxiga granted approval from China’s NMPA for treatment of symptomatic chronic...
AstraZeneca’s Forxiga (dapagliflozin) has been approved in China for use in adults with symptomatic chronic heart failure.
The drug has previously been approved in China...
First patient enrolled in global study of heart failure device trial
Heart failure start-up Acorai has announced the initiation of a global clinical trial with the enrolment of its first patient in London, UK.
The Acorai...
AI model may improve detection of atrial septal defect
An artificial intelligence (AI) model may be more efficient at detecting signatures of atrial septal defect (ASD) in electrocardiograms (ECG) than traditional methods.
This is...
Efforts needed to improve cardiovascular research in Africa
Research published in the journal Circulation: Cardiovascular Quality and Outcomes has highlighted the small number of clinical trials in cardiovascular medicine currently conducted in...
CathVision launches PVI Analyzer and Signal Complexity algorithms following FDA clearance
CathVision has announced US Food and Drug Administration (FDA) clearance and commercial availability of the PVI Analyzer and Signal Complexity algorithms, part of the...
US FDA grants de novo approval for AI-based HCM detection algorithm
Viz.ai has received a de novo approval by the US Food and Drug Administration (FDA) for its Viz HCM module, a hypertrophic cardiomyopathy (HCM)...
“Not just inventing the next stent”: The future of medtech relies...
Ian Meredith is a well-known figure within the field of interventional cardiology, not only for a distinguished academic and clinical career but also his...
US FDA approval granted for Boston Scientific’s POLARx cryoablation system
Boston Scientific has received US Food and Drug Administration (FDA) approval for the POLARx cryoablation system.
The new system, which is indicated for the treatment...
Conventional analysis “may not capture the impact of catheter ablation” in...
Patient-tailored catheter ablation results in a significant reduction in atrial tachyarrhythmia (ATA) burden in shock-resistant persistent atrial fibrillation (AF) patients using implantable cardiac monitors...
Ilika and Cirtec Medical partner on the manufacture and commercialisation of...
Ilika and Cirtec Medical have announced that they have signed a 10-year manufacturing licence to produce the Stereax range of mm-scale batteries at Cirtec’s...
Biosense Webster ablation tools approved for zero fluoroscopy workflow
Biosense Webster has announced that several products in its cardiac ablation portfolio have received approval for a zero fluoroscopy workflow from the US Food...
Multidisciplinary research yields new model for assessing atrial remodelling in AF...
Researchers have presented a new method for assessing atrial remodelling in patients with atrial fibrillation (AF), based on the simultaneous assessment of electrical and...
WHO adds cardiovascular polypill to essential medicines list
The World Health Organization (WHO) has included a cardiovascular polypill—an all-in-one pill containing an antiplatelet, lipid lowering medication, and a blood pressure lowering and...
Study confirms AI detection of HFpEF using a single echocardiogram view
Applying artificial intelligence (AI) to a single apical four chamber (A4C) view echocardiogram provides accurate information to detect heart failure with preserved ejection fraction...
Extreme temperatures and particulate pollution may increase MI mortality risk
The combination of soaring heat and fine particulate pollution may double the risk of myocardial infarction (MI) mortality, according to a new study of...
Protected: ADVERTORIAL: Prucka 3 with CardioLab digital recording system: The gold...
This advertorial has been sponsored by GE Healthcare.
In this white paper Usman Siddiqui (University of Central Florida, Hunters Creek, USA) highlights reasons why the...
Protected: Prucka 3 with CardioLab digital recording system: The gold standard...
This post is sponsored by GE Healthcare
In this white paper, Usman Siddiqui (University of Central Florida, Hunters Creek, USA) highlight reasons why the Prucka...
Biosnese Webster’s Optrell mapping catheter launches in USA
Biosense Webster has today announced the US launch of the Optrell mapping catheter with Trueref technology powered by the Carto 3 system.
The Optrell mapping...
Global Cardiovascular Awards to recognise excellence and innovation in cardiovascular care
Entries are now open for the inaugural edition of the Global Cardiovascular Awards, a recognition scheme highlighting the important contributions made by healthcare professionals...
Enrolment completed in SmartfIRE clinical study
Biosense Webster has announced that enrolment has been completed in the SmartfIRE study evaluating the safety and efficacy of its investigational Thermocool Smarttouch SF...
Shopping trolley AF sensor “holds promise for stroke prevention”
The use of embedded electrocardiogram (ECG) sensors in shopping trolley handles could effectively identify individuals with previously undiagnosed atrial fibrillation (AF). This is among...
Sami Viskin announced as Heart Rhythm editor-in-chief
The Heart Rhythm Society (HRS) has announced the appointment of Sami Viskin (Tel Aviv University, Tel Aviv, Israel) as the new editor-in-chief of Heart...
Medtronic issues Class I recall of ICD and CRT-D devices
Medtronic is recalling all implantable cardioverter defibrillator (ICD) and cardiac resynchronisation (CRT-D) devices manufactured after 2017 with a glassed feedthrough, as there is a...
First patients treated using integrated Abbott and Stereotaxis systems
Stereotaxis has announced that the first patients have been successfully treated utilising Abbott’s EnSite X EP system with Stereotaxis’ robotic magnetic navigation system.
The combination...
CathVision completes latest round of funding
CathVision today announced its most recent financing round of US$9 million from investors.
The financing will help advance commercial operations driving adoption of the ECGenius...
AccurECG analysis system gains US FDA clearance
AccurKardia has announced that its flagship product, the AccurECG analysis system has been granted US Food and Drug Administration (FDA) 510(k) clearance.
AccurECG is a...
First US patients implanted with FIRE1 remote heart failure monitoring system
FIRE1 has announced that the first US patients have been successfully implanted with its FIRE1 system for remote heart failure monitoring in an early...
First patient enrolled in MOJAVE study of DSR 2.0
Sequana Medical NV has announced that the first patient has been enrolled in the MOJAVE study, a randomised controlled Phase 1/2a study in the...
US FDA approves Biotronik’s Amvia Edge portfolio
Biotronik has announced US Food and Drug Administration (FDA) approval of its portfolio of Amvia Edge pacemakers and cardiac resynchronisation therapy pacemaker (CRT-P).
In a...
Researchers develop flexible bioresorbable monitor for cardiac patients
Researchers have developed a soft, fully bioresorbable, transparent microelectrode array (MEA) for monitoring heart disease and dysfunction.
Outlining the design, fabrication, characterisation and validation of...
“World’s first” dual chamber leadless pacemaker system granted US FDA approval
Abbott has announced that the US Food and Drug Administration (FDA) has approved the Aveir dual chamber (DR) leadless pacemaker system, described by the...
Depressed ICD patients “more likely to stop medications”
Patients who feel low when having a cardiac device implanted are more likely to stop taking their heart medications than those without depression, according...
ECG-AI algorithm for early identification of amyloidosis gains US FDA breakthrough...
Anumana has received breakthrough device designation from the US Food and Drug Administration (FDA) for its electrocardiogram (ECG) artificial intelligence (AI) algorithm designed to...
“Promising” longer-term follow-up in real-world study of leadless pacemakers
Findings of a retrospective cohort study assessing the long-term real-world safety and efficacy of leadless pacemakers implanted in patients throughout the Netherlands are “promising...
Complication and mortality rates for catheter ablation of AF have declined...
Procedure-related complications and mortality rates associated with catheter ablation of atrial fibrillation (AF) are low and have declined in the past decade, conclude the...
CorWave closes series C funding round
CorWave has raised €61 million to fund its first industrial deployment and entry into clinical trials.
SPI fund, managed by Bpifrance on behalf of the...
Anxiety affects high proportion of patients with an ICD
Nearly one-third of patients with an implanted device to prevent sudden death have anxiety in the first year while depression affects one in five,...
ESC appoints Jean-François Riffaud as CEO
The European Society of Cardiology (ESC) has announced the appointment of Jean-François Riffaud as its new chief executive officer. Riffaud will replace Isabel Bardinet,...
Arrhythmia Alliance launches SVT Awareness Day
Arrhythmia Alliance has announced the launch of the first SVT Awareness Day (7 June), taking place during World Heart Rhythm Week (5‒11 June) to...
US FDA seeks to “modernise” clinical trials with new draft guidance
The US Food and Drug Administration (FDA) has released draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernising the design...
AI model can allow for interpretation of ECGs as language
Researchers have developed an artificial intelligence (AI) model for electrocardiogram (ECG) analysis that allows for the interpretation of ECGs as language.
This approach can enhance...
Research highlights “strikingly low” use of public defibrillators in cardiac arrest
Defibrillators are being used in just one in 10 cardiac arrests where they are available, according to research presented at the British Cardiovascular Society...
Conformal Medical completes series D financing round
Conformal Medical has announced the successful completion of its series D funding round, raising a total of $35 million. The company is developing the...
Amazon executive joins Medtronic to spearhead development in robotics and implantables
Medtronic has announced that Ken Washington has been appointed chief technology and innovation officer.
Washington joins Medtronic from Amazon where he served as vice president...
First US patients treated in PULSAR study of Globe pulsed field...
Kardium has announced today that the first US patients have been successfully treated in the PULSAR clinical study, using its Globe pulsed-field ablation system.
The...
MONITOR-HF trial results show improvement in quality of life scores for...
New data presented from an investigator-sponsored European trial found managing indicated heart failure patients with Abbott’s CardioMEMS HF system resulted in a significant improvement...
Medtronic gains US FDA nod to apply AccuRyhthm algorithms to Reveal...
Medtronic has announced US Food and Drug Administration market clearance to apply the AccuRhythm AI algorithms to the Reveal LINQ insertable cardiac monitor (ICM),...
HRS 2023: BIO-LIBRA study offers insights into device treatment of non-ischaemic...
Preliminary results from the BIO-LIBRA study, assessing the outcomes of device-treated ventricular arrhythmias or mortality in patients with non-ischaemic cardiomyopathy (NICM) being treated with...
HRS 2023: Dynamic monitoring “improves access to care for AF patients”
Findings from a new clinical trial support use of implantable cardiac monitors (ICM) as a standard of care in managing patients with complex cardiac...
HRS 2023: SOLVE-CRT results “offer new hope for patients with hard-to-treat...
Results from a pivotal clinical trial found a leadless pacemaker can deliver cardiac resynchronisation therapy (CRT) among patients who were not able to be...
US FDA approves Abbott’s TactiFlex ablation catheter
Abbott has announced that the US Food and Drug Administration (FDA) has approved the company's TactiFlex Ablation Catheter, Sensor Enabled, which features a flexible...
HRS 2023: Researchers hope to use AI to “revolutionise” prediction of...
A novel artificial intelligence (AI) model correctly identified patients at near-term risk of sustained ventricular tachycardia (VT) who could potentially benefit from preemptive interventions...
HRS 2023: Weight loss prior to catheter ablation improves outcomes in...
Results from a clinical trial, presented at the 2023 Heart Rhythm Society annual meeting (May 19–21, New Orleans, USA), indicate that overweight and obese...
HRS 2023: PULSED AF study demonstrates reduction in atrial arrhythmia burden...
Medtronic has announced findings from a secondary analysis of the PULSED AF study, demonstrating positive results for the Medtronic PulseSelect pulsed field ablation (PFA)...
Stereotaxis and Abbott integrate cardiac robotics and mapping systems
Stereotaxis has announced a global collaboration with Abbott to integrate Abbott’s EnSite X EP system with Stereotaxis’ Robotic Magnetic Navigation system.
The combination of Abbott’s...
HRS 2023: Aveir DR leadless pacemaker meets primary endpoints in IDE...
Late-breaking results from the AVEIR dual-chamber (DR) i2i Investigational Device Exemption (IDE) study, a large-scale study to assess Abbott’s Aveir dual-chamber leadless pacemaker, have...
US FDA expands indication for Farxiga
AstraZeneca’s Farxiga (dapagliflozin) has been approved in the USA to reduce the risk of cardiovascular (CV) death, hospitalisation for heart failure (hHF) and urgent...
Enrolment completed in Cryocure-VT trial
Adagio Medical has announced the completion of enrolment in its Cryocure-VT trialof ultra-low temperature cryoablation for the treatment of monomorphic ventricular tachycardias.
Sixty patients with...
Medtronic receives US FDA approval for latest Micra leadless pacemakers
Medtronic has received US Food and Drug Administration (FDA) approval of its Micra AV2 and Micra VR2 leadless pacemakers.
Micra AV2 and Micra VR2, the...
One thousand arrhythmia patients treated using Stereotaxis robotic system
Stereotaxis has announced that over 1,000 cardiac arrhythmia patients have been treated using the Genesis Robotic Magnetic Navigation (RMN) system.
Genesis RMN, was first used...
Boston Scientific’s POLARx FIT cryoablation system gains CE mark
Boston Scientific has received CE mark for its POLARx FIT cryoballoon catheter for atrial fibrillation (AF) ablation.
According to the company, the device is the...
SentiAR closes Series B financing round
SentiAR has closed a Series B financing round worth US$8.5 million. The financing was led by cultivate (MD) Ventures and joined by MedVenture Partners...
Medtronic launches technology aimed at simplifying MRI screening for patients with...
Medtronic has announced the launch of MRI Care Pathway, a new system designed to streamline the process of completing magnetic resonance imaging (MRI) scans...
PROACTIVE-HF pivotal trial completes enrolment
Endotronix has announced its PROACTIVE-HF pivotal study has successfully completed enrolment.
The study is designed to evaluate the safety and efficacy of the Cordella pulmonary...
Experts update consensus on left atrial appendage closure
The Society for Cardiovascular Angiography & Interventions (SCAI) and the Heart Rhythm Society (HRS) have released an updated expert consensus statement on transcatheter left...
PADN-5 study results “exciting” for pulmonary artery denervation in heart failure...
Results from the PADN-5 study, investigating the efficacy and safety of pulmonary artery denervation in the treatment of combined postcapillary and precapillary and pulmonary...
Arrhythmia mapping system improves freedom from AF during ablation
Vektor Medical has announced that use of the vMap arrhythmia mapping system during complex atrial fibrillation (AF) ablation was associated with significantly improved freedom...
Robotic electrophysiology programme opens in south eastern USA
Stereotaxis has announced the opening of a new robotic electrophysiology programme at Broward Health Medical Center in Fort Lauderdale, USA. Broward Health is among...
Dual energy AF ablation catheter begins evaluation in SmartfIRE clinical trial
Biosense Webster has announced the first cases with its investigational Thermocool Smarttouch SF dual energy catheter have taken place as part of the SmartfIRE...
EU ministers approve changes to MDR transition timetable
The European Union’s Council of Ministers has today adopted a resolution to extend the deadline for the certification of medical devices under the Medical...
ACC 2023: Pulsed AF trial yields “promising” safety and efficacy results...
Results of the Pulsed AF Pivotal trial, investigating pulsed field ablation (PFA) treatment in patients with paroxysmal and persistent atrial fibrillation (AF), have been...
Biotronik gains CE mark for Selectra 3D implant tools to include...
Biotronik has received CE mark approval for the Selectra 3D implant tools to include left bundle branch area pacing (LBBAP) in addition to His-bundle...
Barostim misses primary endpoint in BEAT-HF postmarket trial
CVRx has announced the preliminary topline results of the BeAT-HF—Baroreflex activation therapy for heart failure—postmarket randomised clinical trial.
The BeAT-HF postmarket phase of the multicentre,...
ACQFORCE FLUTTER trial meets primary safety and efficacy endpoints
Acutus Medical has announced results from the AcQForce Flutter study, evaluating use of the AcQBlate Force sensing ablation catheter and system in the treatment...
GE HealthCare to acquire AI ultrasound developer Caption Health
GE HealthCare has signed an agreement to acquire Caption Health, a developer of artificial intelligence (AI)-driven ultrasound technology.
The Caption Health technology—Caption AI—has been developed...
Abbott announces European and US approvals for ablation technologies
Abbott has today announced receipt of the CE mark for the TactiFlex ablation catheter, sensor enabled (SE), alongside US Food and Drug Administration (FDA)...
Accelerated pacing rate benefits HFpEF patients with pacemakers
Among patients with heart failure with preserved ejection fraction (HFpEF) and a pacemaker, treatment with a moderately accelerated, personalised pacing rate resulted in an...
First patient treated in LeAAPS trial of left atrial appendage occlusion...
AtriCure has announced that the first patient was treated in the LeAAPS clinical trial, a prospective, randomised clinical trial to evaluate the safety and...
One-year data on CLAAS LAAO system demonstrate technical success of procedure
Conformal Medical has announced the presentation of one-year data from the company’s initial left atrial appendage occlusion (LAAO) cases with its novel CLAAS system...
Preclinical study outlines key features of foam-based LAA closure device
A preclinical study demonstrating key features of the foam-based left atrial appendage closure device (CLAAS, Conformal Medical) has been published in the Journal of...
Volta Medical secures multimillion Euro series B funding round
Volta Medical has announced €36 million in new series B funding, bringing the total capital raised to over €70 million.
The company is developing artificial...
Enrolment begins in trial to assess efficacy and safety of abelacimab...
Anthos Therapeutics has announced that it has enrolled the first patient in LILAC-TIMI 76, a phase 3 study to evaluate the efficacy and safety...
Johnson & Johnson completes Abiomed acquisition
Johnson & Johnson has today announced it has completed its acquisition of Abiomed. Abiomed is now part of Johnson & Johnson and will operate...
Cardiology societies urge rethink of randomised controlled trial design
The current model for randomised clinical trials must be redesigned for the modern age, according to the European Society of Cardiology (ESC), American Heart...
EU Commission to propose delay to MDR implementation
Europe’s health commissioner, Stella Kyriakides, has announced that proposals to extend the transition period for the implementation of the European Union’s (EU) Medical Device...
UK regulator approves dapagliflozin for use in heart failure across the...
AstraZeneca has today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted a licence extension for dapagliflozin (Forxiga) in Great Britain...
ESC warns of cardiac device shortage due to implementation of MDR...
The European Society of Cardiology (ESC) has urged European Union (EU) health ministers to act to prevent a “shortfall of essential medical devices for...
Ultromics EchoGo Heart Failure AI solution gains FDA clearance
Ultromics’ EchoGo Heart Failure, an artificial intelligence (AI) solution for echocardiography with the potential to revolutionise the diagnosis of heart failure with preserved ejection...
Abbott receives Health Canada approval for Aveir VR leadless pacemaker
Abbott has announced that Health Canada has approved the Aveir single-chamber (VR) leadless pacemaker.
The Aveir leadless pacemaker is implanted directly inside the heart's right...
Study compares risk of dementia in AF patients undergoing catheter ablation...
Biosense Webster has announced the publication of data from a study comparing the risk of dementia in patients with atrial fibrillation (AF) who were...
RELIEF clinical study to assess use of Cardioform septal occluder for...
WL Gore & Associates has announced that it is initiating the RELIEF clinical study—an investigational study to evaluate the safety and efficacy of transcatheter...
AF screening strategy “would save societal costs”
Screening to detect atrial fibrillation (AF) in older people would not only increase the chance of preventing stroke, it would also save money for...
Health economic analysis finds benefit to AF screening with Zio XT...
iRhythm Technologies has announced a new health economic analysis of the mSToPS study, presented at the American Heart Association (AHA) scientific sessions 2022 (5–7...
Study of Signal Complexity algorithm for AF detection launched
CathVision has announced the investigation of the Signal Complexity algorithm designed to visualise and quantify atrial fibrillation (AF) complexity parameters in patients with persistent...
Acutus acheives milestone in sale of left-heart access portfolio to Medtronic
Acutus Medical has announced that it has achieved the first milestone under the asset purchase agreement of its left-heart access portfolio with Medtronic.
This triggers...
Boston begins European launch of LUX-Dx insertable cardiac monitor
Boston Scientific has announced the European launch of the LUX-Dx insertable cardiac monitor (ICM) system, a long-term diagnostic device inserted under the skin of...
First patients treated in study of Globe pulsed field ablation system
Kardium has announced the successful first-in-human study of its next generation Globe pulsed field system to treat atrial fibrillation (AF) using pulsed field ablation...
Apixaban associated with lower risk of gastrointestinal bleeding in AF patients...
Use of apixaban was associated with a lower risk of gastrointestinal bleed and similar rates of ischaemic stroke or systemic embolism, intracranial haemorrhage and...
Johnson & Johnson is to acquire Abiomed
Johnson & Johnson is to acquire Abiomed, it was announced today, after the two organisations entered into a definitive agreement under which Johnson &...
Adagio Medical announces patient enrolment in PARALELL trial
Adagio Medical has announced its first pulsed field cryoablation (PFCA) procedure performed using the Adagio CryoPulse catheter system as part of the PARALELL (Pulsed...
LeAAPS trial to explore benefit of left atrial appendage occlusion in...
Researchers are to investigate the safety and efficacy of performing left atrial appendage occlusion in patients at high risk for atrial fibrillation (AF) who...
AccurKardia and Mawi link up to add automated ECG analytics for...
AccurKardia, a software company that provides clinical-grade, device agnostic, automated electrocardiogram (ECG) analytics, has announced it will collaborate with Mawi, a medtech provider of...
Rates of stroke and embolism lower with apixaban compared to rivaroxaban
In a large, population-based study of patients with atrial fibrillation (AF) and valvular heart disease, those receiving apixaban had a lower risk for ischaemic...
Medtronic gains expanded labelling for SelectSecure cardiac lead
Medtronic has received US Food and Drug Administration (FDA) approval for expanded labelling for the SelectSecure Model 3830 cardiac lead for left bundle branch...
Catheter ablation of AF “increased cerebral blood flow”, observational study finds
Catheter ablation of atrial fibrillation (AF) has favourable effects on cerebral blood flow, particularly in non-paroxysmal AF, research published in JACC: Clinical Electrophysiology.
The results...
Heliostar radiofrequency balloon ablation catheter gets European launch
Biosense Webster has announced the European launch of the Heliostar radiofrequency balloon ablation catheter. Heliostar is indicated for use in catheter-based cardiac electrophysiological mapping...
Cardiac mapping system “reduces procedural duration and fluoroscopy use”
Vektor Medical has announced study results that demonstrate a reduction in total procedural duration, fluoroscopy use, and cost after implementation of vMap, its cardiac...
Smartwatch detection of AF “more challenging in patients with pre-existing cardiac...
A real-world study of smartwatch electrocardiography (ECG) tools for the detection of atrial fibrillation (AF) has found that the use of such devices is...
AI algorithm identifies hidden AF cases in screening study
Researchers have used artificial intelligence (AI) to evaluate patients’ electrocardiograms (ECGs) in a targeted strategy to screen for atrial fibrillation (AF). In the digitally-enabled,...
Puzzle Medical wins 2022 TCT Shark Tank innovation competition
Puzzle Medical Devices was announced as the winner of the Shark Tank innovation competition at the 2022 Transcatheter Cardiovascular Therapeutics meeting (TCT, 16–19 September,...
Two decades of development in AF treatment and education
This year marked the 20th edition of the Atrial Fibrillation Symposium (AFIB2022; 24–25 May, Copenhagen, Denmark) which, over its lifetime, has evolved to become...
Medtronic receives FDA clearance for expanded paediatric indication of Linq II...
Medtronic has announced that the Linq II insertable cardiac monitor (ICM) system has received 510(k) clearance from the US Food and Drug Administration (FDA)...
TCT 2022: Amulet occluder keeps pace with Watchman at three years
Long-term follow-up of patients with non-valvular atrial fibrillation (AF) receiving the Amplatzer Amulet left atrial appendage occlusion (LAAO) device have shown continued safety and...
Study warns of “low quality” ICD information available in online videos
Implantable cardioverter defibrillator (ICD) information on YouTube is of low and highly-variable quality, according to research presented at the American College of Cardiology (ACC)...
Researchers find link between COVID-19 and new-onset AF
A study in Circulation: Arrhythmia and Electrophysiology has identified new-onset atrial fibrillation (AF) in one in 20 patients hospitalised with COVID-19.
Using data from the...
AHA calls for action to improve care following CIED infection
A new report from the American Heart Association’s (AHA’s) National Cardiac Implantable Electronic Device (CIED) Infection Initiative aims to improve adherence to guidelines on...
Ra Medical Systems and Catheter Precision agree merger
Ra Medical Systems has entered into a merger agreement with Catheter Precision.
Under the terms of the agreement, Catheter Precision will become a wholly owned...
Vascade vascular and venous closure devices gain CE mark
Haemonetics Corporation has received CE mark certification for its Vascade vascular closure and Vascade MVP venous vascular closure systems.
The CE marking will allow...
Results of cuffless blood pressure monitor presented at AHA Hypertension Sessions
Results of an analysis of Aktiia’s cuffless blood pressure (BP) monitoring system are being presented at the American Heart Association (AHA) Hypertension Scientific Sessions...
Biotronik ties in with AliveCor on heart rhythm monitoring technology
Biotronik has announced a partnership with AliveCor, the developer of personal electrocardiogram (ECG) technology and services.
The partnership will bring together Biotronik’s Biomonitor injectable cardiac...
IMPACT II trial expands to USA following FDA exemption approval
The US Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) to Attune Medical to evaluate the company’s ensoETM in the...
Findings of vMAP study detail accuracy of cardiac mapping technology
Vektor Medical has announced the publication of a peer-reviewed manuscript of the clinical data from a study evaluating the accuracy of its vMap technology...
AtriAN initiates second trial of pulsed field ablation in cardiothoracic surgery...
AtriAN Medical has announced that it has completed enrolment of a second study using its selective pulsed field ablation (PFA) technology for the treatment...
Biosense Webster launches Octaray mapping catheter
Biosense Webster has announced the release of the Octaray mapping catheter, developed for the mapping of cardiac arrhythmias including atrial fibrillation (AF). The catheter...
New DAPT labelling approved for Watchman FLX device
Boston Scientific has received US Food and Drug Administration (FDA) approval to expand the instructions for use labelling for the current-generation Watchman FLX left...
LifeTech gains medical insurance coverage for clinical trial of LAmbre LAA...
LifeTech has announced that a US Food and Drug Administration (FDA)-approved investigator-initiated pre-market clinical trial of its proprietary LAmbre Plus left atrial appendage (LAA)...
ESC 2022: Findings of CAPLA trial “do not support inclusion of...
The addition of posterior wall isolation (PWI) does not improve arrhythmia outcomes compared with pulmonary vein isolation (PVI) alone in patients undergoing first time...
Study looks at efficacy of AI-based EGM analysis tool
Volta Medical has announced that peer-reviewed results from the company’s Ev-AIFib proof of concept study with its VX1 decision support software has been published...
ESC 2022: Risk score predicts mortality for AF patients after TAVI
Researchers have developed a risk score to predict mortality for patients with atrial fibrillation (AF) who have undergone a successful transcatheter aortic valve implantation...
Medtronic adds cardiac mapping platform through Affera acquisition
Medtronic has announced that it has completed the acquisition of Affera. The acquisition will expand Medtronic’s cardiac ablation portfolio to include its first cardiac...
Centauri pulsed electric field system gains CE mark approval
Galaxy Medical has announced that it received the CE mark for its Centauri pulsed electric field (PEF) system and launched its commercial programme.
The approval...
ESC 2022: Favourable results for Medtronic’s EV ICD system in pivotal...
Medtronic has announced that its investigational EV ICD system—a defibrillator with the lead placed under the breastbone, outside of the heart and veins—achieved a...
ESC 2022: Smartphone screening doubles AF detection rate in eBRAVE-AF
Screening for atrial fibrillation (AF) using a smartphone app more than doubled the detection and treatment rate in older people compared to routine screening,...
ESC 2022: AI outshines sonographer echocardiogram assessment in EchoNet-RCT
Results of one of the first and only randomised, blinded trials to assess the use of an artificial intelligence (AI) algorithm as an assessment...
ESC 2022: Guidelines call for public engagement in tackling sudden cardiac...
New guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death have been published today in the European...
Merit Medical launches SafeGuard Focus Cool compression device
Merit Medical has announced the launch of its SafeGuard Focus Cool compression device.
It is part of a broader cardiac portfolio that offers products and...
FDA approves clinical trial of SERF ablation for VT patients
Thermedical has announced that the US Food & Drug Administration (FDA) has approved an open-label, single-arm interventional clinical trial to evaluate the safety and...
ESC 2022: Medical cannabis users “at elevated risk” of arrhythmia
Cannabis prescribed for chronic pain is associated with an elevated risk of heart rhythm disorders, according to research presented at the European Society of...
Recent AF diagnosis and multiple comorbidities warrants early rhythm control strategy
Patients with recently diagnosed atrial fibrillation (AF) with a high burden of comorbidities should be considered for early rhythm control to reduce cardiovascular outcomes,...
NICE recommends use of KardiaMobile to measure QT interval in people...
The National Institute for Health and Care Excellence (NICE) has issued draft guidance recommending KardiaMobile 6L for measuring cardiac QT interval in people having...
AHA scientific statement offers insight into sleep-disordered breathing and its link...
A new scientific statement from the American Heart Association (AHA) provides guidance about sleep-disordered breathing and its association with the development of cardiac arrhythmia.
Published...
CathVision secures US$7.2 million in funding to advance EP recording technology
CathVision has secured US$7.2 million in funding from existing investors to help advance commercial operations driving adoption of the ECGenius system, the company's EP...
First-in-man study yields promising results for saline-enhanced radio frequency VT ablation
A first-in-human multicentre trial using in-catheter, heated saline-enhanced radio frequency (SERF) ablation for patients with ventricular tachycardia (VT) has reported that the technique showed...
OSYPKA AG gains CE mark for class III pacing electrode
OSYPKA AG, a medical device company based in Rheinfelden, Germany, has received the CE mark under the European Union’s Medical Device Regulation (MDR) for...
Speaker line-up announced for HRX digital health meeting
The Heart Rhythm Society (HRS) has announced the full line-up of speakers and sessions for its first annual HRX meeting (8–10 September, San Diego,...
“Worrisome” rise in cardiovascular disease predicted out to 2060
Projected rates of cardiovascular risk factors and disease will increase significantly in the USA by 2060, a study published in the Journal of the...
Genetic “cure” for cardiomyopathy is selected as winner of Big Beat...
A project to develop genetic therapies to effectively cure cardiomyopathy has been announced as the winner of the British Heart Foundation’s Big Beat Challenge,...
Cryocure-2 study reports 85% freedom from AF at one year
Adagio Medical has announced the publication of the results of its Cryocure-2 ultra-low temperature cryoablation (ULTC) study in patients with atrial fibrillation (AF) in...
First patient enrolled in RESTORE-1 clinical trial
InCarda Therapeutics has announced enrolment of the first patient in the company’s pivotal phase 3 RESTORE-1 clinical trial of InRhythm (orally inhaled flecainide) in...
Japanese approval of Acutus imaging and mapping systems
Acutus Medical has announced approval of its AcQMap high resolution imaging and mapping system and the AcQMap 3D imaging and mapping catheter in Japan.
Acutus’...
iRhythm’s ZEUS system gains US FDA approval
iRhythm Technologies has received US Food and Drug Administration (FDA) 510(k) clearance for its ZEUS (Zio ECG Utilization Software) system for the Zio Watch.
Produced...
Acutus Medical makes senior appointment
Acutus Medical has announced that David Roman has been appointed president and chief executive officer, and member of the Board of Directors, effective immediately....
Analysis sets out generalisability of EAST-AFNET 4 trial findings
Around 80% of patients diagnosed with atrial fibrillation (AF) in the UK population are eligible for early rhythm control, an analysis of the EAST-AFNET...
Boston Scientific partners with Telefónica España to enhance remote support capabilities
Boston Scientific is collaborating with Telefónica España to provide ‘advanced healthcare technology’, including 5G, through its recently launched Remote Clinical Support Centre—RhythmCARE—which is intended...
New funding for research to examine use of blood pressure cuffs...
A research project at the University of Leeds (Leeds, UK) aiming to find an easier way to establish the optimum heart rate for heart...
Stereotaxis submits CE mark application for MAGiC catheter
Stereotaxis has announced the CE mark submission for its MAGiC catheter, a robotically navigated magnetic interventional ablation catheter for minimally invasive cardiac ablation procedures.
MAGiC...
Abbott’s Ensite X mapping system available in Canada
Abbott has introduced its EnSite X EP a cardiac mapping platform with EnSite Omnipolar Technology (OT) in Canada.
The platform allows for the creation of...
Biotronik uses remote support feature for ICM implants
Biotronik’s LiveSupport feature was used to remotely support two Biomonitor implantable cardiac monitor (ICM) implants shortly after launch. Both procedures were performed with a...
Catheter ablation “economically attractive” compared to drug therapy for AF
Catheter ablation of atrial fibrillation (AF) was economically attractive compared with drug therapy in the CABANA (Catheter ablation versus antiarrhythmic drug therapy for atrial...
CardiNor agrees US distribution agreement with IBL-America
Cardiac testing company CardiNor AS has announced that it has signed an exclusive agreement with IBL-America for sales of the CardiNor Secretoneurin ELISA test...
HeartBeam expands software platform to cover unstable angina
HeartBeam is expanding the available patient population for its emergency department software technology solution. In evaluating the electrocardiogram (ECG) database for the clinical validation...
Acutus closes sale of left-heart access portfolio to Medtronic
Acutus Medical has announced the completion of the first of two closings for its previously disclosed sale of the company’s left-heart access portfolio to...
AF after surgery is linked to an increased risk of heart...
People who develop an arrhythmia after surgery have an increased risk of subsequently being admitted to hospital with heart failure, according to a study...
Acutus launches expanded suite of left-heart access products
Acutus Medical has announced the commercial launch of an expanded suite of left-heart access products to now include the AcQCross Qx system for use...
Thromboembolic cerebral events ‘rare’ in patients undergoing PFA
In patients treated with pulsed field ablation (PFA) for symptomatic paroxysmal atrial fibrillation (AF), the incidence of asymptomatic thromboembolic cerebral events or lesions detected...
Deep-learning model could predict AF after 24-hour ECG monitoring
A study, published in the European Heart Journal–Digital Health, shows the predictive potential of a deep-learning model in identifying patients at risk of atrial...
New guidance issued on screening for sudden cardiac death in athletes
Recommendations on how to use gene testing to prevent sudden cardiac death in athletes and enable safe exercise have been published in the European...
German GALLERY registry reports on safety and efficacy of laser lead...
A national, multicentre registry investigating the safety and efficacy of laser lead extraction has reported high success- and low procedure-related complication rates associated with...
CONFORM pivotal trial of CLAAS system begins enrolment
Conformal Medical has announced the launch of the CONFORM pivotal trial with the enrolment of the first patients at two US sites.
The investigational device...
TVT 2022: DAPT after Watchman FLX LAAO is comparable to currently...
Dual antiplatelet therapy (DAPT) after left atrial appendage occlusion (LAAO) using the Watchman FLX (Boston Scientific) device was comparable in terms of rates of...
Air pollution exposure may heighten risk of ventricular arrhythmias in ICD...
Incidence of ventricular arrhythmias can be linked to days when air pollution is high, according to research presented at Heart Failure 2022 (21–24 May,...
First patient treated in HEAL-IST clinical trial
AtriCure has announced that the first patient has been treated in the HEAL-IST trial, evaluating the safety and effectiveness of AtriCure’s Isolator Synergy Clamp...
FDA approves Abbott’s Aveir leadless pacemaker
Abbott has announced that the US Food and Drug Administration (FDA) has approved the Aveir single-chamber (VR) leadless pacemaker for the treatment of patients...
Meta-analysis reveals “global collateral damage” of pandemic on cardiovascular care
A study has revealed the “global collateral damage” caused by the disruption to cardiac services caused by the COVID-19 pandemic. Writing in the European...
HRS 2022: S-ICD can be considered as an alternative to transvenous...
The use of a subcutaneous-implantable defibrillator (S-ICD, Boston Scientific) reduced the rate of major, lead-related complications by as much as 92% when compared to...
HRS 2022: Registry data support role of cardioneural ablation to address...
Findings of the US multicentre cardioneural ablation (CNA) registry were presented during a late-breaking clinical trial session at the Heart Rhythm Society’s 2022 annual...
First patients enrolled in IMPACT II study
Attune Medical has announced that the first patients have been enrolled in the IMPACT II— Improving Oesophageal Protection During Catheter Ablation for Atrial Fibrillation—study,...
FDA approval granted for inHEART 3D imaging analysis software
inHEART has received US Food and Drug Administration (FDA) 510(k) clearance for its inHEART Models software suite that enables 3D visualisation and analysis of...
Cordella meets safety and efficacy endpoints in SIRONA 2 clinical trial
Endotronix has announced data from the SIRONA 2 clinical trial evaluating safety and efficacy of its Cordella pulmonary artery pressure sensor system in New...
“Solid” data point to benefit of early rhythm control for AF...
Findings of the EAST-AFNET 4 trial, examining the benefit of early rhythm control therapy in patients with newly diagnosed atrial fibrillation (AF), should influence...
HRS 2022: Same day discharge “benefits AF ablation patients”
Results of a study presented at the Heart Rhythm Society’s 2022 annual meeting (HRS 2022, 29 April–1 May, San Francisco, USA) show that the...
HRS 2022: AI-based app used to detect left-ventricular dysfunction
Use of an artificial intelligence (AI)-based app using electrocardiogram (ECG) signals recorded with an Apple Watch is able to identify left-ventricular dysfunction, research presented...
FDA clears ECGenius high-fidelity, low-noise electrophysiology recording technology
CathVision has announced US Food and Drug Administration (FDA) 510(k) clearance of the ECGenius electrophysiology recording system. ECGenius acquires high-fidelity, low-noise, cardiac electrograms to...
Ceryx Medical raises seed funding for its bionic pacing device
Ceryx Medical has raised £3.8m in seed funding which will be used to commercialise its technology and commence the first-in-human clinical study of the...
HRS 2022: Trio of studies demonstrate positive outcomes of CSP for...
The Heart Rhythm Society (HRS) has announced the findings of three clinical trials demonstrating positive outcomes of conduction system pacing (CSP) for patients in...
HRS 2022: Aggressive blood pressure control reduces risk of left ventricular...
Results from a new clinical trial found aggressive blood pressure (BP) control reduced the risk of left-ventricular conduction disease. This study is the first...
Abbott announces US availability of Amplatzer steerable delivery sheath for Amulet...
Abbott has announced US availability of its Amplatzer steerable delivery sheath, which is used with the company's Amplatzer Amulet left atrial appendage (LAA) occluder...
New data from STROKE AF trial shared at HRS 2022
Medtronic has announced new data from the STROKE AF clinical trial, showing that large and small vessel ischaemic stroke patients who receive short-term or...
CathVision completes enrolment in ECGenius study
CathVision has completed patient enrolment in the CathVision ECGenius System clinical evaluation study at the University of Vermont Medical Center (Burlington, USA). The study...
Early experience shows benefit to high-power short-duration AF ablation
The use of high-power, short duration ablation for atrial fibrillation (AF) has the potential to speed up procedural times and increase the number of...
“Hybrid” model likely to be a hallmark of the post-pandemic era...
The pandemic saw a boom in the use of remote technologies and telehealth for patient monitoring and management, including for patients with heart failure—and...
AI algorithms to be added to Medtronic’s LINQ II ICMs in...
Medtronic has announced two AccuRhythm AI algorithms will be applied to LINQ II insertable cardiac monitors (ICM) through cloud-based updates in Europe later this...
Fitbit’s PPG algorithm gains FDA clearance
Fitbit has received clearance from the US Food and Drug Administration (FDA) for a new photoplethysmography (PPG) algorithm to identify atrial fibrillation (AF). The...
Study results “offer great promise for using smartwatches for arrhythmia screening”
Cardiologs has announced the results of a clinical study showing that its deep learning artificial intelligence (AI) software reduces inconclusive results returned by the...
Boston expands digital offering with European launch of Heart Connect
Among the array of remote monitoring and digital arrhythmia management tools on display at the 2022 European Heart Rhythm Association annual meeting (EHRA 2022,...
FEops Heartguide receives FDA clearance for LAAO planning capabilities
FEops has announced that it received authorisation from the US Food and Drug Administration (FDA) for FEops Heartguide pre-operative planning of left atrial appendage...
Trio of studies on Zio AF detection patch presented at ACC.22
iRhythm Technologies has announced the results of three clinical research studies presented at the American College of Cardiology’s annual scientific sessions (ACC 2022, 2–4...
FDA approval for Abbott’s Aveir VR leadless pacemaker
Abbott has announced that the US Food and Drug Administration (FDA) has approved the Aveir single-chamber (VR) leadless pacemaker for the treatment of patients...
EHRA 2022: GPs back routine AF screening
Screening for atrial fibrillation (AF) should be integrated into flu vaccination and cancer screening programmes, according to a survey of general practitioners (GPs) conducted...
EHRA 2022: ECG reading could pinpoint COVID-19 patients at high risk
A simple electrocardiogram (ECG) can pinpoint hospitalised COVID-19 patients at high risk of death who might need intensive management, according to the authors of...
EHRA 2022: Overweight patients at greater risk of AF recurrence
Overweight patients with atrial fibrillation (AF) are more likely to experience a return of the heart rhythm disorder after a corrective procedure than those...
ACC.22: Analysis shows low rate of device removal in case of...
Results of a large-scale, real-world analysis of US Centers for Medicare & Medicaid Services (CMS) data on the rates of guideline adherence and associated...
EHRA 2022: PROFID points to role for CMR in predicting sudden...
Use of cardiac magnetic resonance (CMR) may relevant role of CMR in risk stratification for sudden cardiac death after myocardial infarction, to late-breaking research...
EHRA 2022: New guidance seeks to prevent cardiac device interference
Recommendations on the prevention and management of interference caused by medical procedures in patients with implanted electronic cardiac devices has been published today in...
EHRA 2022: Experts preach caution on “over-the-counter” heart rhythm monitoring devices
The “exponential growth” in the use of digital devices for monitoring arrhythmias has led to the development of a new international consensus document. The...
SafeCross transseptal balloon gets first commercial use
East End Medical has announced the first commercial use of its SafeCross transseptal radiofrequency (RF) puncture and steerable balloon introducer system. The system is...
Updated cardiac mapping system among Philips’ EHRA 2022 offering
The launch of the latest KODEX-EPD cardiac mapping and navigation system is among the features Royal Philips will showcase at the 2022 European Heart...
GE Healthcare ties in with AliveCor for remote ECG management
GE Healthcare and AliveCor have announced a partnership to deliver medical-grade six-lead electrocardiograms (ECGs) taken by patients on an AliveCor KardiaMobile 6L ECG device...
Algorithm could enhance prevention of sudden cardiac arrest
Researchers have developed a clinical algorithm that distinguishes between treatable sudden cardiac arrest and untreatable forms of the condition.
The findings, Journal of the American...
Poland establishes its first robotic electrophysiology unit
Stereotaxis has announced that Poland’s National Institute of Cardiology in Warsaw has established the first robotic electrophysiology programme in the country with Stereotaxis’ Genesis...
Analysis reveals impact of kidney function on antithrombotic therapy bleeding risk
Research published in the journal BMC Medicine investigates the impact of kidney function in patients on antithrombotic therapy.
The study, a post hoc sub-group analysis...
Expert group sets out principles for device-led hypertension trials
A consensus document outlining design principles and outcome definitions for device-based therapies for hypertension has been published in the journal Circulation.
The development of the...
Hospitals trial AI-backed technology to speed up arrhythmia diagnosis
Hospitals in England are trialling remote monitoring technology from iRhythm Technologies—Zio XT—which is designed to aid the detection of arrhythmias supported by artificial intelligence.
Typically...
Study shows improved AF detection using MCOT patch and implantable loop...
Royal Philips has announced new research evaluating mobile cardiac outpatient telemetry (MCOT) as a first-line diagnostic ambulatory monitoring solution with post-cryptogenic stroke patients.
The study...
Researchers warn of safety risk to ICDs from mobile devices
Portable electronic devices containing magnets may inhibit pulse generators for implanted cardiac devices (ICDs) and pacemakers according to new research published in Circulation: Arrhythmia...
CRT 2022: SURPASS registry shows low rate of adverse events associated...
Results from a new analysis assessing real-world outcomes with the Watchman FLX (Boston Scientific) left atrial appendage closure (LAAC) demonstrated a low rate of...
Women underrepresented in cardiovascular clinical trial leadership positions
Women remain underrepresented in leading cardiovascular clinical trials, corresponding with underrepresentation and a lack of gender diversity among presenters at scientific meetings, according to...
Partnership to promote wearable tech in cardiology trials
Wearable technology and digital health specialist Activinsights has announced a partnership agreement with the cardiovascular research organisation Cardialysis to promote the use of remote...
Physcological stress linked with initiation and potentiation of AF
A review paper published in JACC: Clinical Electrophysiology explores the potential mechanisms linking stress and atrial fibrillation (AF), and the possible uses of stress...
New data underpin drive towards earlier AF ablation strategies
Historically, catheter ablation has been reserved for atrial fibrillation (AF) patients who have failed to respond to, or tolerate antiarrhythmic drug therapy, electrophysiologist Dhiraj...
Siemens introduces “integrated” cath lab imaging system, Artis icono biplane
Siemens Healthineers has announced the launch of Artis icono biplane—an angiography system with detectors optimised in size for integrated use in the cath lab.
The...
Abbott’s CardioMEMS HF system receives FDA approval for use in earlier-stage...
Abbott has announced that the US Food and Drug Administration (FDA) has approved an expanded indication for the company’s CardioMEMS HF system to support...
Freezor cardiac cryoablation catheters approved to treat paediatric AVNRT
Medtronic has announced that the Freezor and Freezor Xtra cardiac cryoablation catheters are approved by the US Food and Drug Administration (FDA) to treat...
UK study shows lack of awareness over signs of arrhythmia
Fewer than half of UK citizens are aware of the link between arrhythmia and stroke, while around one in five people with a personal...
Robert Califf to return as US FDA commissioner
Cardiologist and researcher Robert Califf has been confirmed as the commissioner of the US Food and Drug Administration (FDA). Califf returns to the role...
Boston Scientific closes acquisition of Baylis Medical Company
Boston Scientific has announced the close of its acquisition of Baylis Medical Company, a company that offers advanced transseptal access solutions as well as...
UCSD is the first hospital to offer vMap arrhythmia mapping software
Vektor Medical has announced that the University of California, San Diego Health (UCSD, San Diego, USA) is the first hospital system to offer the...
Second phase of ASCENT ASD trial begins
atHeart Medical has announced that it has received US Food and Drug Administration (FDA) approval for the start of the second phase of its...
Corvia atrial shunt fails to reduce heart failure events in REDUCE...
The placement of an interarterial shunt device—the Corvia atrial shunt (Corvia Medical)—did not reduce the total rate of heart failure events in a population...
First patient receives Aveir dual-chamber leadless pacemaker
Abbott has announced the first patient implants of a dual-chamber leadless pacemaker system as part of its AVEIR DR i2i pivotal clinical study. The...
Breakthrough designation granted to CardiaAMP cell therapy system for heart failure...
BioCardia has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the CardiAMP cell therapy system for the...
Same-day discharge could become the standard strategy following LAAO
A same-day discharge strategy for left atrial appendage occlusion (LAAO) could become the standard approach for this technique, according to the authors of a...
AliveCor launches credit card sized ECG device
AliveCor has announced the launch of KardiaMobile Card—an electrocardiogram (ECG) device the size of a standard credit card.
“After disrupting traditional ECG monitoring with our...
Philips launches at-home 12-lead ECG integrated solution for decentralised clinical trials
Royal Philips has announced the introduction of a full-service, at-home, 12-lead electrocardiogram (ECG) solution for use in decentralised clinical trials. The clinical-grade solution is...
Study provides “clear evidence” that alcohol is a risk factor for...
Acute alcohol consumption is associated with a higher risk of atrial fibrillation (AF), a study published in Nature Cardiovascular Research has concluded
The study is...
Philips supports AHA’s CIED infection campaign
Royal Philips is supporting the American Heart Association’s (AHA’S) effort to generate awareness among cross-disciplinary specialties and improve survival rates from cardiovascular implantable electronic...
EnSite X EP cardiac mapping platform gains US FDA approval
Abbott has received clearance from the US Food and Drug Administration (FDA) for the EnSite X EP system with EnSite Omnipolar Technology (OT), a...
Japanese reimbursement approval for Micra AV TPS
Medtronic has received approval from Japan's Ministry of Health, Labor and Welfare for the sale and reimbursement of the Micra AV Transcatheter Pacing System...
Medtronic to acquire Affera
Medtronic has announced that it has entered into an agreement to acquire medical technology company Affera.
Affera designs and manufactures cardiac mapping and navigation systems...
Khaldoun Tarakji joins Medtronic’s cardiac ablation division
Khaldoun Tarakji, associate section head of cardiac electrophysiology at the Heart, Vascular, and Thoracic Institute at Cleveland Clinic (Cleveland, USA) has joined Medtronic as...
NICE approves KardiaMobile for AF detection in patients with suspected paroxysmal...
The National Institute for Health and Care Excellence (NICE) has issued Medical Technologies Guidance (MTG) recommending KardiaMobile (AliveCor) as an option for detecting atrial...
Endotronix announces FDA approval for PROACTIVE-HF pivotal trial design change
Endotronix has announced that the US Food and Drug Administration (FDA) has granted approval for an amendment to the company's PROACTIVE-HF study, a pivotal...
First patients treated using Adagio Medical’s pulsed field cryoablation system
Adagio Medical has announced first-in-human cases of pulsed field cryoablation (PFCA) for the treatment of atrial fibrillation (AF).
The cases were performed at Medicover Hospital,...
First US hospitals to treat patients using AI ablation software
Volta Medical has announced the introduction of VX1 artificial intelligence (AI) software at three US hospitals. New York Presbyterian Queens, Northwell Health’s Lenox Hill...
First patient treated in SPHERE PerAF trial
Affera has announced that the first patient was treated in the recently approved SPHERE PerAF trial, a US Food and Drug Administration (FDA) Investigational...
EMPAKT CHF trial points to change in assessment acute heart failure...
FAST BioMedical has announced the publication of additional results from the EMPAKT CHF (Estimating versus Measuring Plasma Volume and Kidney Function in Acute Decompensated...
First-in-man procedures performed with Globe PFA system
Kardium has announced the completion of successful first-in-human (FIH) procedures with the Globe pulsed field system.
Vivek Reddy of Mount Sinai Hospital (New York, USA)...
Implicity receives FDA clearance for AI-Powered ECG analyser
Implicity has announced US Food and Drug Administration (FDA) clearance for a novel medical algorithm that analyses ECG data from implantable loop recorders (ILRs).
“This...
LifeTech and Medtronic extend HeartTone partnership
LifeTech Scientific Corporation has announced that it has extended its agreements with Medtronic to further the strategic collaboration on the HeartTone domestic pacemaker project...
Patients undergoing robotic ablation found to have reduced incidence of silent...
Stereotaxis has announced the publication of the results of a prospective, multicentre study comparing the incidence of silent cerebral embolism (SCE) in atrial fibrillation...
Philips expands cardiac ultrasound portfolio
Royal Philips has announced an expansion of its ultrasound portfolio with new imaging tools and features for cardiology, designed to “increase diagnostic confidence and...
SyMap Medical closes US$100 million financing round
SyMap Medical has announced the completion of a financing round which will be used to accelerate global clinical trials for the company’s renal mapping...
Survey: Bullying “commonly experienced” by UK cardiology trainees
One in 10 junior doctors training to be cardiologists in the UK say they have been bullied, the results of a survey published online...
Restore Medical announces preliminary results from first-in-human use of ContraBand
Restore Medical has announced preliminary results of the first-in-human clinical trial of ContraBand, a breakthrough treatment for patients suffering from congestive heart failure. The...
Patients receiving CIEDs “at higher risk” for persistent opioid use
Persistent opioid use following a cardiac implantable electronic device (CIED) procedure is common, according to a study published in Circulation, which reports that 12%...
Canon announces introduction of new AI-based cardiac CT diagnostic technology
Canon Medical has announced the introduction of the Precise IQ Engine (PIQE) deep-learning reconstruction (DLR) and SilverBeam filter.
PIQE, which Canon describes as super-resolution deep-learning...
AcQForce PFA-CE study begins for focal PFA therapy to treat atrial...
Acutus Medical has announced the initiation of AcQForce PFA-CE, a clinical study that will evaluate the safety and performance of the company’s focal force...
Cardiologs’ AI receives FDA clearance for paediatric use
Cardiologs announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to use its AI-powered cardiac diagnostics platform for...
ESC publishes pandemic guidance on diagnosis and management of cardiovascular disease
European Society of Cardiology (ESC) guidance for the diagnosis and management of cardiovascular disease during the COVID-19 pandemic has been published in the European...
Cardialen gets FDA approval for study of its Multipulse Therapy for...
Cardialen has received approval from the US Food and Drug Administration (FDA) for an investigational device exemption (IDE) to begin a clinical trial of...
AHA 2021: Fitbit shows promise for detection of AF
Results of the Fitbit Heart study, presented during a late-breaking science session at the American Heart Association’s Scientific Sessions 2021 (AHA 2021; 13–15 November;...
HeartVista receives FDA clearance for use of its AI software on...
HeartVista has received US Food and Drug Administration (FDA) 510(k) clearance to deliver its AI-assisted One Click magnetic resonance imaging (MRI) acquisition software on...
What to expect from AHA 2021
Ahead of the American Heart Association’s 2021 annual scientific sessions (AHA 2021, 13–15 November, virtual), Cardiac Rhythm News speaks to the meeting’s programme committee...
Aveir meets primary safety and efficacy endpoints in Leadless II IDE...
Data from the global Leadless II IDE study evaluating the Aveir (Abbott) leadless pacemaker in patients with certain abnormal heart rhythms show that the...
Vektor Medical’s vMap receives FDA 510(k) clearance
Vektor Medical has announced US Food and Drug Administration (FDA) 510(k) clearance for its novel computational electrocardiogram (ECG) mapping system, vMap.
vMap is designed to...
Patients more likely to survive a cardiac arrest in the operating...
Patients who went into cardiac arrest in the cardiac cath lab were more likely to survive to hospital discharge than those who had a...
Medtronic announces 2045 net zero emissions ambition to combat climate change
Medtronic has announced its ambition to achieve net zero carbon emissions by fiscal year 2045 across its operations and value chain to accelerate efforts...
Philips expands its cardiac diagnostics and monitoring portfolio with Cardiologs acquisition
Royal Philips has signed an agreement to acquire Cardiologs, a developer of cardiac diagnostics using artificial intelligence (AI) and cloud technology. Cardiologs will further...
TCT 2021: SWISS-APERO trial finds lower rate of peri-device leak in...
Findings of the SWISS-APERO trial, presented at the Transcatheter Cardiovascular Therapeutics annual meeting (TCT 2021, 4–6 November, Orlando USA and virtual), comparing the Amulet...
TCT 2021: LAAC remains non-inferior to NOAC for cardiovascular events at...
Left atrial appendage occlusion (LAAC) remains non-inferior to non vitamin-K-antagonists (NOACs) for the prevention of major cardiovascular, neurological or bleeding events in patients with...
Vuno’s AI-based ECG analysis software gains breakthrough designation
South Korean artificial intelligence (AI) developer Vuno has announced that the Korean Ministry of Food and Drug Safety (KFDA) has designated the company's AI-based...
Non-invasive technique could detect thrombosis caused by AF
Researchers from Massachusetts General Hospital (MGH, Boston, USA) have reported the detection and characterisation of thrombosis using fibrin-targeted positron emission tomography and magnetic resonance...
Study finds no link between hydroxychloroquine and QTc interval prolongation in...
Research presented at the American College of Rheumatology’s annual meeting (ACR Convergence, 3–9 November, virtual) shows that hydroxychloroquine does not appear to be associated...
CHANGE AFib to explore impact of early treatment of AF
A pragmatic clinical trial—CHANGE AFib—will determine whether early treatment with the antiarrhythmic drug dronedarone improves cardiovascular and long-term outcomes in patients presenting with first-detected...
First patients enrolled in PVISION study of PVI analyser
CathVision has announced the first patient enrolments in the PVISION multicentre clinical study, investigating the automated assessment of pulmonary vein isolation (PVI) using the...
AI algorithm learns to predict heart failure through subtle ECG changes
An artificial intelligence (AI)-based computer algorithm created by researchers at the Mount Sinai Health System (New York, USA) has been able to learn how...
Ethnic and racial minority cardiologists face professional discrimination and exclusion
Ethnic and racial minority cardiologists report career satisfaction but face professional discrimination and exclusion. This was the main finding of the American College of...
Study shows safety and efficacy of robotic-guided ablation to treat paediatric...
Stereotaxis has announced publication of a study in the International Journal of Cardiology: Heart & Vascular demonstrating superior safety and efficacy of Stereotaxis’ robotic...
Baylis Medical Company to sell its cardiology business to Boston Scientific
Baylis Medical Company has reached an agreement to sell its cardiology business to Boston Scientific.
The acquisition, for an upfront payment of US$1.75 billion, subject...
Study highlights temporal relationship between AF and stroke
Medtronic has announced the publication of a study demonstrating, through the use of a continuous rhythm monitoring device, that atrial fibrillation (AF) is directly...
Vascade MVP vascular closure system gains same-day discharge labelling for AF...
Haemonetics Corporation has announced that the Vascade MVP venous vascular closure system is has received a US Food and Drug (FDA) indication for same-day...
FDA monitoring gender differences in outcomes with LAAO devices
The US Food and Drug Administration (FDA) has informed healthcare providers of recent information about the potential for differences in procedural outcomes between women...
Abbott’s Amplatzer Talisman gains FDA approval
Abbott has announced that the US Food and Drug Administration (FDA) has approved the company's Amplatzer Talisman PFO Occlusion System to treat people with...
First post-approval procedures performed using Heliostar balloon ablation catheter
Biosense Webster, part of the Johnson & Johnson Medical Devices Companies has announced post-approval procedures were successfully performed with the Heliostar radiofrequency balloon ablation...
Robotics in the EP lab: Pointing the way to the future
Benjamin D’Souza, assistant professor of Medicine at the University of Pennsylvania, cardiac electrophysiologist at Penn Presbyterian Medical Center, Philadelphia, USA, discusses the recent developments...
HRX digital health event moved to September 2022
The Heart Rhythm Society (HRS) has announced that its cardiovascular digital health conference—HRX—has been rescheduled to September 2022. The event had been due to...
Shrinking ECG waveforms can predict worsening health of COVID-19 and influenza...
Specific and dynamic changes on electrocardiograms (ECGs) of hospitalised patients with COVID-19 or influenza can help predict a timeframe for worsening health and death,...
Continuous heart rhythm monitoring “does not prevent strokes in those at...
Continuous heart rhythm monitoring—with anticoagulation if atrial fibrillation (AF) is detected—does not prevent strokes in those at risk. That is the finding of the...
APAF-CRT: Ablation and CRT beat drug therapy in permanent AF patients...
Ablation plus cardiac resynchronisation therapy (CRT) is superior to pharmacological rate control in reducing mortality in severely symptomatic permanent atrial fibrillation (AF) patients with...
Targeting atrial fibrosis in AF patients with low levels of disease...
Image-guided fibrosis ablation in addition to pulmonary vein isolation (PVI) does not improve ablation success rates compared to PVI alone in patients with persistent...
HRC 2021 to focus on multidisciplinary heart rhythm care
The Arrhythmia Alliance’s 2021 Heart Rhythm Congress (A-A HRC 2021 3–6 October, virtual) returns for its second ever digital edition, which will see more...
First patients enrolled in SPACE-AF study
Galaxy Medical announced today the initiation of the SPACE-AF study with enrolment of the first two patients at Southlake Regional Health Centre in Newmarket,...
QardioDirect adds ambulatory cardiac monitoring to diagnose AF
QardioDirect, the all-inclusive service for remote patient monitoring (RPM) from Qardio, now includes ambulatory cardiac monitoring to help diagnose atrial fibrillation (AF) along with...
VitalConnect launches updated version of VistaCenter for remote cardiac monitoring
VitalConnect has announced the launch of a new version of VistaCenter for cardiac and remote patient monitoring. This new version brings updates including simplified...
Medtronic leads pilot programme to address disparities in sudden cardiac arrest...
Medtronic has announced a pilot programme with Mpirik to address disparities in care associated with the prevention of sudden cardiac arrest (SCA), a condition...
Zoll signs agreement to acquire Itamar Medical
Zoll Medical and Itamar Medical have announced that the two companies signed a definitive agreement under which Zoll Medical will acquire all outstanding ordinary...
CERTITUDE registry data shed light on home monitoring of cardiac devices
Biotronik has announced the first observational results of the CERTITUDE registry, documenting real-world clinical outcomes of patients in the USA who use implantable loop...
Stereotaxis and Microport EP announce Chinese market partnership
Stereotaxis and Shanghai Microport EP Medtech have announced a broad collaboration to advance technology innovation and commercial adoption of robotics in electrophysiology in China.
The...
Use of the antibiotic-eluting envelope in CIEDs: Has it reached prime...
Bhargav Vemulapalli, Shreya Srivastava and John Kassotis (New Brunswick, USA) review the potential use of antibiotic-eluting envelopes (ABEs) based on available clinical data, while...
ESC 2021: AliveCor touts results of KardiaMobile 6L in AF detection...
AliveCor has announced the results of what it describes as the largest study to assess the reliability of the detection of atrial fibrillation (AF)...
Cardiomatics raises US$3.2 million to expand cloud AI tool for ECG...
Cardiomatics, the cloud AI tool that allows any trained medical staff to carry out electrocardiogram (ECG) analysis, has raised US$3.2 million in seed funding...
ESC 2021: Real-world data show reduction in complications with Micra leadless...
Medtronic has announced new data from the Micra Coverage with Evidence Development (CED) study, which showed the Micra transcatheter pacing system (TPS) was associated...
ESC 2021: Initial data from inspIRE clinical trial released
Biosense Webster, part of the Johnson & Johnson Medical Devices Companies, has announced the presentation of data from the inspIRE clinical trial at the...
New ESC guidelines on cardiac pacing and CRT published
The European Society of Cardiology (ESC) Guidelines on cardiac pacing and cardiac resynchronisation therapy (CRT) have been published online in European Heart Journal.
The use...
ESC 2021: Abbott’s Amulet occluder shows promise against Watchman device in...
Abbott has announced late-breaking data from the Amulet LAA Occluder IDE trial, a multicentre, head-to-head study comparing the company's Amplatzer Amulet left atrial appendage...
ESC 2021: GUIDE-HF shows reduction in heart failure hospitalisations using CardioMEMS
Abbott has announced results of the landmark GUIDE-HF clinical trial, a 1,000 patient randomised study designed to assess the benefits of the CardioMEMS HF...
ESC 2021: Drones touted as the future of defibrillator delivery
The world’s first feasibility study has found that drones can be used to deliver defibrillators to people with suspected cardiac arrest in the community....
ESC 2021: New guidelines for the diagnosis and treatment of acute...
The European Society of Cardiology (ESC) Guidelines for the diagnosis and treatment of acute and chronic heart failure are published online today in European...
ESC 2021: ACTIVE-AF finds benefits for exercise programme in AF patients
A six-month exercise programme helps maintain normal heart rhythm and reduces the severity of symptoms in patients with atrial fibrillation (AF), according to late-breaking...
Ultromics completes US$33 million Series B funding round
Ultromics, a developer of AI enabled cardiovascular imaging solutions, has announced that it has raised US$33 million in a Series B funding round. The...
FDA grants breakthrough device designation to Impella ECP
The US Food and Drug Administration (FDA) has granted breakthrough device designation to Abiomed’s Impella ECP expandable percutaneous heart pump. The designation means the...
CardioNXT gains FDA marketing clearance for heart treatment delivery platform
CardioNXT has received marketing clearance from the US Food and Drug Administration (FDA) for the platform technology comprised of the iMap 3D Navigation &...
Algorithm predicts heart failure hospitalisations
Biotronik has announced the results from a new study published in EP Europace this week confirming that heart failure (HF) decompensation can be predicted...
Night shift work may be linked to increased risk of AF
People who work night shifts are at increased risk of developing atrial fibrillation (AF), according to research published in the European Heart Journal.
The study...
Abbott’s Amplatzer Amulet gains US FDA approval
Abbott has announced that the US Food and Drug Administration (FDA) has approved the company's Amplatzer Amulet Left Atrial Appendage Occluder to treat people...
Acutus receives FDA and CE mark approvals for AcQMap 8
Acutus Medical has received US Food and Drug Administration (FDA) and CE mark clearance for its suite of software upgrades known collectively as AcQMap...
Human-monitored ECG outperforms AI in detection of significant arrhythmias
Long-term continuous electrocardiogtraphy (LT-ECG), coupled with oversight by a physician, significantly outperforms algorithm-dependent mobile cardiac telemetry (MCT) in the detection of significant arrhythmias according...
Caption Health gains NTAP authorisation from CMS for AI-guided ultrasound platform
Caption Health has announced that the Centers for Medicare and Medicaid Services (CMS) have approved new technology add-on payments (NTAP) for the Caption Guidance...
Women underrepresented in cardiovascular clinical trials
Women remain underrepresented in cardiovascular clinical trials despite initiatives to ensure broader inclusivity. This is according to two reports, both published in the last...
Exploring the potential of remote atrial fibrillation diagnosis through digital technology
The challenge of rapid detection and diagnosis of atrial fibrillation (AF) has been made even harder with the onset of the COVID-19 pandemic, and...
Tyrx envelope shown to be cost effective in European healthcare markets
Economic analyses from the WRAP-IT study, sponsored by Medtronic, demonstrate the Tyrx cardiac absorbable antibacterial envelope’s (Tyrx Envelope) cost effectiveness in European markets for...
HRS 2021: Early rhythm control benefits AF patients with heart failure
Rhythm control therapy offers a clinical benefit when initiated within one year of a diagnosis of atrial fibrillation (AF) in patients with signs or...
HRS 2021: CABANA analysis points to economic case for catheter ablation
A new analysis of the CABANA (Catheter ablation versus antiarrhythmic drug therapy for atrial fibrillation) suggests that catheter ablation offers positive economic outcomes compared...
HRS 2021: Early VT catheter ablation beats medical therapy in patients...
Results of the PAUSE-SCD trial show a significant reduction in risk of ventricular tachycardia (VT) recurrence, cardiovascular hospitalisation, and death when catheter ablation is...
HRS 2021: DOACs reduce risk of stroke in patients undergoing left...
Use of direct oral anticoagulants (DOACs) in patients undergoing ventricular tachycardia radio frequency ablation (RFA) is associated with a reduced risk of transient ischaemic...
Abbott launches Jot Dx ICM in the USA
Abbott has announced the US launch of Jot Dx, the company’s latest insertable cardiac monitor (ICM). In a press release, Abbott said that the...
AccuRhythm AI algorithms gain US FDA clearance
Medtronic has announced US Food and Drug Administration (FDA) clearance for two AccuRhythm AI algorithms for use with the LINQ II insertable cardiac monitor...
AliveCor and Acutus partner for post-market study
AliveCor and Acutus Medical will collaborate to assess the integration of data collection tools across the cardiology continuum of care, which the companies say...
AngelMed launches its Guardian device in the USA
Angel Medical Systems (AngelMed) has announced the first commercial implantation and US launch of its The Guardian device. The procedure marks the Guardian's first...
Affera’s SpherePVI gets first-in-human use
Affera has announced the first-in-human use of its circumferential pulmonary vein isolation (PVI) pulsed field ablation (PFA) catheter, SpherePVI.
The work was conducted as part...
MicroPort enters into Series C financing agreements
MicroPort Cardiac Rhythm Management (CRM) has entered into definitive agreements in connection with its Series C financing with total investment proceeds of US$150 million.
Hillhouse...
Tyrx Envelope is effective at reducing infections in CIED patients with...
Medtronic has announced new data from the WRAP-IT study published in Heart Rhythm, which it said demonstrate a significantly lower infection risk for patients...
Cardiac rehabilitation reduces rehospitalisation, death in ICD recipients
People who made even small increases in their daily physical activity levels after receiving an implantable cardioverter defibrillator (ICD) experienced fewer incidences of hospitalisation...
“No evidence” to link moderate coffee consumption with arrhythmia risk
There is no evidence that moderate coffee consumption can cause cardiac arrhythmia, according to the authors of a prospective, population-based community cohort study, findings...
TVT 2021: Two-year PINNACLE FLX results report low rate of ischaemic...
Two-year results from the PINNACLE FLX clinical trial assessing the safety and efficacy of the next-generation Watchman FLX (Boston Scientific) left atrial appendage closure...
Ancora Heart secures US$80 million in financing
Ancora Heart has closed US$80 million in equity financing, with the funds to be used to accelerate the CORCINCH-HF pivotal clinical study of the...
Research highlights AF risk factors for HCM patients
The authors of research published in JACC: Clinical Electrophysiology claim that their findings will help physicians to identify, treat and prevent atrial fibrillation (AF)...
First patients treated with reSept ASD occluder in IDE trial
atHeart Medical has announced the successful treatment of the first five patients in its ASCENT ASD US Investigational Device Exemption (IDE) pivotal trial. This...
AliveCor gains US FDA clearance for KardiaMobile 6L to calculate patients’...
AliveCor has today announced the receipt of 510(k) clearance from the US Food and Drug Administration (FDA) for healthcare professionals to use the KardiaMobile...
FDA approval for SafeCross transseptal RF system
East End Medical has announced it has received US Food and Drug Administration (FDA) clearance for the company's SafeCross transseptal radiofrequency (RF) puncture &...
CABANA trial shows favourable results for catheter ablation among ethnic minority...
Among racial or ethnic minority patients enrolled in the North American cohort of the CABANA (Catheter ablation versus antiarrhythmic drug therapy for atrial fibrillation)...
Adagio’s ultra-low temperature cryoablation system in first-in-human use
Adagio Medical has announced successful first-in-human use of ultra-low temperature cryoablation (ULTC) for the treatment of monomorphic ventricular tachycardia (VT).
The two-hour mapping and ablation...
First patient treated with VeriSight Pro 3D intracardiac echocardiography catheter
Royal Philips has announced the first procedure using its real-time 3D intracardiac echocardiography (ICE) catheter. The left atrial appendage occlusion (LAAO) procedure was carried...
Vaccine myocarditis risk “far outweighed” by COVID-19 infection
The risk of heart damage from COVID-19 infection is far greater than that from receiving a dose of the messenger RNA (mRNA) vaccine, according...
Boston acquires remaining shares of Farapulse
Boston Scientific has exercised its option to acquire the remaining shares of Farapulse. The acquisition will complement the existing Boston Scientific electrophysiology portfolio to...
Medtronic launches app-based study to probe relationship between AF disease burden...
Medtronic has announced the initiation of DEFINE AFib, an app-based research study which aims to address unanswered questions around atrial fibrillation (AF) burden and...
AngelMed gains FDA approval for enhanced real-time cardiac monitor for ACS...
Angel Medical Systems (AngelMed) has announced US Food and Drug Administration (FDA) approval of the second-generation AngelMed Guardian device. The AngelMed Guardian system is...
AHA statement on AF and HFrEF positive for catheter ablation
The American Heart Association (AHA) has this week issued a scientific statement on the management of atrial fibrillation (AF) in patients with heart failure...
CardioFocus receives Japanese approval for HeartLight X3
CardioFocus has announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the company's HeartLight X3 System for marketing in Japan....
Expanded FDA approval for Medtronic’s Arctic Front cryoablation catheter
Medtronic has received US Food and Drug Administration (FDA) expanded approval for the Arctic Front family of cardiac cryoablation catheters for the treatment of...
Heart Rhythm Society names new chief strategy officer
The Heart Rhythm Society (HRS) has announced the appointment of Simintha Esson as its new chief strategy officer (CSO).
In this role, Esson is responsible...
ESC president urges vigilance over signs of cardiac arrest following Christian...
The president of the European Society of Cardiology (ESC) has called for greater awareness of the signs of cardiac arrest and how to respond,...
Remote heart failure monitoring platform offered to Imperial College patients
Imperial College Healthcare NHS Trust (London, UK) is working with remote healthcare developer, Luscii, to provide an at-home monitoring platform to support patients with...
Bluetooth-equipped pacemakers receive CE mark approval
MicroPort CRM has announced the European launch of Alizea and Borea pacemakers after receiving the CE mark under the new Medical Device Regulation. The...
Tech advancements in remote monitoring are connecting patients to better care
Robert Kowal is the chief medical officer of the Cardiac Rhythm businesses at Medtronic. In this interview he shares his views and experiences on...
Vaccination centre screening campaign reports success at “opportunistic” AF detection
A campaign by Arrhythmia Alliance to DETECT atrial fibrillation (AF)—the most common type of arrhythmia—found that 6% of people aged 65 or older attending...
RAFT-AF fails to show benefit of AF ablation in heart failure...
Among patients with both heart failure and atrial fibrillation (AF), treatment strategies focused on rhythm control, using catheter ablation, and those focused on rate...
Pulmonary artery proportional pulse pressure monitoring could improve survival for heart...
A new physiological measurement of heart function could improve survival for people with heart failure by identifying high-risk patients who require tailored treatments, a...
GE Healthcare and ACC partner to advance AI in cardiology
GE Healthcare is collaborating with the American College of Cardiology (ACC) through support of and participation in the ACC’s Applied Health Innovation Consortium for...
Medtronic announces publication of STROKE AF trial results
Medtronic has announced clinical trial results from the STROKE AF trial demonstrating the superiority of the Reveal LINQ insertable cardiac monitor (ICM) to detect...
Abbott’s Amplatzer steerable delivery sheath gains EU and Canadian approvals
Abbott has announced it has received CE mark and Health Canada approval for its Amplatzer steerable delivery sheath, which is used with the company's...
Medtronic stops sale of its HVAD system
Medtronic is stopping the distribution and sale of the Medtronic HVAD system. This morning, the company notified physicians to cease new implants of the...
Siemens Healthineers receives CE mark for the ACUSON AcuNav Volume ICE...
Siemens Healthineers has announced that it has received CE Mark for the AcuNav Volume ICE (intracardiac echocardiography) catheter, an imaging guide that provides real-time,...
Abiomed acquires breakthrough device company preCARDIA
Abiomed has acquired preCARDIA, developer of a proprietary catheter and controller to expand options for patients with acute decompensated heart failure (ADHF). The preCARDIA...
Implicity and MicroPort CRM partner for US distribution agreement
Implicity has announced a distribution agreement with MicroPort CRM, through which MicroPort CRM can sell and distribute Implicity's cloud-based solution in the USA as...
Wearables study shows physical activity reduces AF risk
Physical activity that conforms to medical and health association guidelines is associated with a lower risk of atrial fibrillation (AF) and stroke, according to...
MDR comes into effect across EU
The European Union (EU) Medical Devices Regulation (MDR) takes effect from today (26 May 2021).
The Regulation revises quality and safety standards and the range...
iRhythm gains two FDA approvals for updates to its Zio system
iRhythm Technologies has announced two US Food and Drug Administration (FDA) 510K clearances—one for a new and improved design of its flagship monitor and...
Cardiomatics partners for tool to analyse ECG signals from paediatric patients
Cardiomatics and the Medical University of Warsaw, Warsaw, Poland are developing a tool for automatic assessment, analysis, and interpretation of electrocardiographic signals (ECG) from...
FDA issues public warning over interference from consumer electricals on implanted...
The US Food and Drug Administration (FDA) has issued advice to patients with implanted devices such as pacemakers or implantable defibrillators to take precautions...
ACC.21: Pandemic has seen burnout “double” among cardiology professionals
The proportion of cardiologists reporting burnout has nearly doubled during the COVID-19 pandemic, according to research presented at the American College of Cardiology’s 70th...
ACC.21: Registry data show low rate of stroke at one year...
Transcatheter left atrial appendage occlusion (LAAO) with a Watchman (Boston Scientific) device was associated with a low rate of stroke at one year, even...
ACC.21: LAAO after heart surgery offers “new paradigm” for stroke prevention...
Patients with an elevated risk of stroke due to arrhythmia or atrial fibrillation (AF), were much less likely to suffer a stroke after undergoing...
AI allows early diagnosis of low ejection fraction in primary care
An electrocardiogram (EKG)-based artificial intelligence (AI) algorithm based can enable the early diagnosis of low ejection fraction in patients in routine primary care, according...
Single-shot pulsed-field ablation yields “excellent” PVI durability
Pulmonary vein isolation (PVI) with a “single-shot” pulsed-field ablation (PFA) catheter results in excellent PVI durability and acceptable safety with a low one-year rate...
Acutus Medical announces CE mark approval for suite of EP products
Acutus Medical has announced CE mark approval for a broad suite of electrophysiology (EP) products including the AcQCross family of universal transseptal crossing devices,...
Hostile environment: Cardiologists report high prevalence of discrimination and harassment in...
Discrimination and harassment are a common experience among those working in cardiology, according to the findings from a global survey carried out by the...
Galaxy Medical and Japan Lifeline enter distribution agreement for pulsed electric...
Galaxy Medical (Galaxy) and Japan Lifeline (JLL) have announced an exclusive distribution agreement for the ALPHA1 ablation catheter in the USA, developed by Japan...
Cardiology trainees require training to adapt to shift towards telemedicine
A significant proportion of cardiology trainees are uncomfortable with using telemedicine and feel that better preparation for new-tech medicine is needed, findings of a...
Abbott initiates trial focusing on twin AF and heart failure treatments
Abbott has announced a new trial focused on improving the treatment for people simultaneously battling both atrial fibrillation (AF) and heart failure.
The TAP-CHF trial...
AtriCure’s EPi-Sense system approved by US FDA for treatment of long-standing...
AtriCure has announced US Food and Drug Administration (FDA) approval of the EPi-Sense system to treat patients diagnosed with long-standing persistent atrial fibrillation (AF).
The...
Hospitalised COVID-19 patients at risk of developing heart failure
Patients hospitalised with COVID-19 may be at risk of developing heart failure even if they do not have a previous history of heart disease...
EHRA 2021: Study advocates screening ICD patients for depression and anxiety
Patients receiving an implantable cardioverter defibrillator (ICD) should be regularly screened for anxiety and depression, according to research presented at the European Heart Rhythm...
Smartphone ECG screening app aided detection of AF among American Indians
A smartphone-based electrocardiogram (ECG) screening accurately detected previously unknown atrial fibrillation (AF) in American Indians, and more than half who were diagnosed were younger...
EHRA 2021: Diabetic patients could be screened for AF during foot...
Atrial fibrillation (AF) could be detected during annual foot assessments in patients with diabetes, according to research presented today at the European Heart Rhythm...
Putting the patient at the centre of the AF treatment strategy
This article was sponsored by Biosense Webster
Putting the patient at the centre of the discussion is vital to setting the right strategy for the...
Oxford study to assess smart devices for AF detection
A project at Oxford University Hospitals NHS Foundation Trust (Oxford, UK) to test how effective smart devices are at detecting heart rhythm problems has...
AcQCross transseptal crossing devices gain US FDA clearance
Acutus Medical has announced US Food and Drug Administration (FDA) clearance of the AcQCross family of universal transseptal crossing devices. The transseptal puncture system...
MultiPulse therapy “shows promise” in the treatment of AF
Cardialen has announced the publication of a first-in-human study in the Journal of the American College of Cardiology: Clinical Electrophysiology investigating its low-voltage MultiPulse...
Report aims to improve diagnosis and treatment of SVT
The charity Arrhythmia Alliance has launched the Arrhythmia Alliance Healthcare Pioneers Report—Showcasing Best Practice in SVT to provide examples of good care to improve...
COVID-19 “lays the foundation for a digital shift in cardiovascular care”
More patients, particularly those with medical risk factors or from underserved communities, opted into telehealth appointments for their cardiovascular care during the COVID-19 pandemic,...
Charity targets vaccine centres for opportunistic AF screening campaign
AF Association has launched an opportunistic screening programme to DETECT atrial fibrillation (AF) at COVID-19 vaccination clinics across the UK. The charity has created...
ACC launches NCDR EP device implant registry
The American College of Cardiology (ACC) has launched the EP Device Implant Registry, which will include data on ICD and CRT-D procedures previously captured...
US enrolment in AcQForce Flutter IDE clinical trial commences
Acutus Medical has announced initial US enrolment in the company’s AcQForce Flutter Investigational Device Exemption (IDE) clinical trial. The trial is expected to enrol...
Dipti Itchhaporia begins term as ACC president
Dipti Itchhaporia has today begun her term as president of the American College of Cardiology (ACC). During her one-year presidency, she will lead the...
DOACs show better safety and effectiveness versus warfarin in patients with...
Patients with valvular atrial fibrillation (AF) who were new users of direct oral anticoagulants (DOACs) were at lower risk for ischaemic stroke or systemic...
One in three female cardiologists report unwanted advances
More than a third of female cardiologists polled in a UK survey on discrimination and sexism in the profession have reported receiving unwanted sexual...
US FDA grants Breakthrough Device Designation for AF ECG analysis platform
Tempus has announced that the US Food & Drug Administration (FDA) has granted the company Breakthrough Device Designation for its ECG analysis platform. The...
Daiichi Sankyo leads partnership to improve access to at-home AF diagnostics
Daiichi Sankyo has announced that it has entered into a collaborative agreement with three technology partners—FibriCheck, neoHealthTech and Capitol Medicare—to improve timely detection and...
Mavacamten granted US FDA new drug application
Bristol Myers Squibb has announced that the US Food and Drug Administration (FDA) has accepted its new drug application (NDA) for mavacamten, an investigational,...
Higher procedural volume linked to better outcomes for LAAO
Higher procedural volume is associated with better outcomes for percutaneous left atrial appendage occlusion (LAAO) procedures, research published online in JACC: Cardiovascular Interventions has...
Index-beat approach improves diagnosis of heart failure in AF patients
An assessment method known as the index-beat approach could improve the diagnosis of heart failure in patients with atrial fibrillation (AF), authors of a...
Medtronic receives CE mark for catheter system and cardiac pacing lead...
Medtronic has announced CE mark approval for the SelectSite C304-HIS deflectable catheter system, as well as CE mark labelling expansion for the SelectSecure MRI...
Looking ahead to AFIB2021
Far from being the first event in the electrophysiology calendar now to make the switch to a digital-only format, the 2021 edition of the...
Qardio receives US FDA clearance for QardioCore continuous ambulatory ECG
Qardio has announced that the US Food and Drug Administration (FDA) has granted the company 510(k) clearance for its QardioCore ambulatory ECG device. QardioCore...
Five-year results of Gore REDUCE clinical study published
Five-year follow-up results from the Gore REDUCE study, assessing the Gore Cardioform or Helex septal occluder versus antiplatelet therapy in long-term recurrent stroke prevention,...
ACC.21 late-breaking clinical trial programme announced
The American College of Cardiology (ACC) has announced a number of the late-breaking clinical trials to be presented at its 70th annual scientific session...
CorSystem announces first use of Bipolar Ablation Adapter
CorSystem has announced the first use of its Bipolar Ablation Adapter since the device received CE mark in July 2020.
The patient who underwent treatment...
Inflammatory heart disease “rare” among athletes with COVID-19
Inflammatory heart disease is a rare finding among professional athletes with mild or asymptomatic COVID-19 infection, a large-scale study has found. The study, led...
ControlRad Select imaging system gains FDA market clearance
ControlRad has announced US Food and Drug Administration (FDA) 510(k) clearance to market ControlRad Select, a technology that utilises proprietary semi-transparent filters, a user-interface...
First procedures performed in pivotal trial to evaluate PulseSelect PFA system
Medtronic has announced the first procedures in the investigational device exemption (IDE) pivotal trial to evaluate the PulseSelect pulsed field ablation (PFA) system, a...
AF burden at six months predictive of hard clinical outcomes in...
Atrial fibrillation (AF) burden at six months after catheter ablation is predictive of all-cause mortality and heart failure hospitalisation, in AF patients with heart...
Societies collaborate to develop universal heart failure definition
A global collaboration between international heart failure bodies seeks to standardise the language and practices around the definition and classification of heart failure around...
Open-source platform could aid study of AF
An open-source platform, OpenEP, has been made available to advance research on atrial fibrillation (AF), which developers claim can perform 90% of the analyses...
First patients treated in ADVENT trial of pulsed field ablation system
FARAPULSE has announced that the first patients have been treated in the ADVENT trial, a US Food and Drug Administration (FDA) Investigational Device Exemption...
SCREEN-AF study results published in JAMA Cardiology
iRhythm Technologies has announced the results of the SCREEN-AF study, led by researchers at Sunnybrook Health Sciences Centre in Toronto, Canada and University Hospital...
Analysis of REVERSE trial points to CRT benefit for heart failure...
Medtronic has announced new results from the REVERSE trial, evaluating outcomes of cardiac resynchronisation therapy (CRT) for patients with mild heart failure (HF). The...
HeartLight X3 pivotal study meets safety and efficacy endpoints
CardioFocus has announced that results from the HeartLight X3 Pivotal Study have been published online in the journal Circulation: Arrhythmia and Electrophysiology (CircEP), showing...
Piccolo Medical receives US FDA clearance for SmartPICC system
Piccolo Medical has announced that it has received US Food and Drug Administration (FDA) clearance of its SmartPICC system.
The SmartPICC system offers the ability...
ACC.21 switches to a virtual-only meeting
The American College of Cardiology (ACC) has announced that its 70th annual scientific session, will be held as an all virtual meeting. The meeting...
Urgent action needed to address growing burden of heart failure
Urgent action is needed to address the growing burden of heart failure and the impact of COVID-19 in the UK, according to a report...
RhythMedix releases its next-generation wearable cardiac telemetry monitor
RhythMedix has announced the release of its next-generation RhythmStar wearable device with built-in 4G cellular connectivity. The novel cardiac telemetry monitor is worn for...
MicroPort Academy CRM launched to aid training in cardiac pacing therapy
MicroPort CRM has launched an online education website—MicroPort Academy CRM—dedicated to cardiac pacing therapy and the functionality of MicroPort CRM products.
MicroPort Academy CRM provides...
Global heart failure cases soar since 1990
The number of patients with heart failure worldwide nearly doubled from 33.5 million in 1990 to 64.3 million in 2017 according to research published...
New recommendations issued on antithrombotic treatment of AF patients undergoing PCI
Updated recommendations on the optimal antithrombotic treatment of patients with atrial fibrillation (AF) receiving oral anticoagulants after undergoing percutaneous coronary intervention (PCI) have been...
MedLumics closes on financing round and makes board appointment
MedLumics has announced that it has closed an €18 million (US$21.7 million) financing round and has appointed Rich Ferrari as Chairman of the Board...
CardiacSense’s AF monitoring watch gains CE mark
CardiacSense has received the CE mark to market and sell a medical grade watch which can detect and remotely monitor atrial fibrillation (AF) and...
Philips completes acquisition of cardiac diagnostics specialist BioTelemetry
Royal Philips has announced that it has completed the acquisition of BioTelemetry, a US provider of remote cardiac diagnostics and monitoring.
The acquisition of BioTelemetry...
“Strong evidence” of a causal link between high blood pressure and...
A study published in the European Journal of Preventive Cardiology provides “strong evidence” of a causal relationship between elevated blood pressure and atrial fibrillation...
B-Secur receives FDA clearance for its HeartKey EKG/ECG technology
B-Secur has announced that it has received US Food and Drug Administration (FDA) 510(K) clearance for its HeartKey software library.
B-Secur’s HeartKey is a suite...
AF Symposium 2021: Experts debate early ablation strategy in AF
The merits of catheter ablation as a first-line treatment for atrial fibrillation (AF) were considered during the second day of AF Symposium 2021 (29–31...
AF Symposium 2021: HARTCAP-AF supports hybrid over catheter ablation
Hybrid ablation, a procedure which involves “attacking” the atrial substrate from the epicardium and endocardium, has been shown to result in significantly higher freedom...
AF Symposium 2021: Studies explore lattice-tip catheter strategies for AF
Findings of two studies investigating the use of a lattice-tip catheter for the treatment of atrial fibrillation (AF) were presented during a late-breaking trial...
AI-enabled mobile device rapidly and accurately determines QTc
Researchers using artificial intelligence (AI) have determined that a smartphone-enabled mobile EKG device can accurately determine a patient’s QT. This can be used to...
AF Symposium 2021: Hybrid, multidisciplinary therapy superior to catheter ablation for...
Results of a sub-analysis of the CONVERGE clinical trial, presented during a late-breaking trial session at the digital AF Symposium (29–31 January, virtual), suggest...
Medtronic receives FDA approval for DiamondTemp ablation system
Medtronic has received US Food and Drug Administration (FDA) approval for the DiamondTemp ablation (DTA) system which treats patients with recurrent, symptomatic paroxysmal atrial...
AF Symposium 2021: Live case from ECLIPSE-AF study to feature
Galaxy Medical, a developer of pulsed electric field (PEF) technology for the treatment of cardiac arrhythmias, has announced that the proprietary Centauri system will...
AF Symposium 2021: Early results of CathVision Cube to be announced
CathVision ApS has announced that its novel cardiac electrophysiology system and artificial intelligence platform to guide ablation therapy for heart rhythm disorders, will be...
AF Symposium 2021: Two cases highlight Acutus’ mapping technology
Acutus Medical has announced a number presentations relating to its mapping and ablation procedures during 26th Annual International AF Symposium (29–31 January, virtual). The...
Farapulse gains CE mark for its pulsed field ablation system
Farapulse announced that it has received the CE mark for its pulsed field ablation (PFA) system for the treatment of paroxysmal atrial fibrillation (AF)....
RHYTHM AI announces latest publication of data backing its STAR Mapping...
RHYTHM AI has announced publication of a clinical outcome study for its STAR (Stochastic Trajectory Analysis of Ranked signals) Mapping system, which is designed...
Cardialen awarded US$2.8 million grant for study of low-energy cardioversion in...
Cardialen has been awarded a US$2.8 million National Institutes of Health (NIH) phase II SBIR grant to further the clinical study of low-energy cardioversion...
Kardium secures financing to advance Globe mapping and ablation system
Kardium has raised US$115 million in a new financing round, which will be used to accelerate commercial growth of the Globe mapping and ablation...
Blood pressure bracelet “offers greater insight” into hypertension
Following the announcement of CE mark approval for the Aktiia cuffless blood pressure monitor bracelet, Gregoire Wuerzner (Lausanne University Hospital and University of Lausanne,...
Richer European countries have higher AF death rates than their less...
The wealthiest countries in Europe have higher death rates from atrial fibrillation (AF) than the least wealthy and these death rates are increasing more...
Aktiia’s wrist-mounted blood pressure monitor gains CE mark
Aktiia has announced that its automated blood pressure monitoring system has received the CE mark as a Class IIa medical device. With the CE...
InCarda Therapeutics announces enrolment of first US patient in phase 2...
InCarda Therapeutics has announced dosing of the first US patient in the company’s multinational INSTANT Phase 2 clinical trial of InRhythm (flecainide for inhalation)...
Boston Scientific to acquire Preventice Solutions
Boston Scientific has entered into a definitive agreement to acquire Preventice Solutions, a privately-held company which offers a full portfolio of mobile cardiac health...
Remote technology in cardiac care is “here to stay”
Robert Klempfner, is director of the Israeli Center for Cardiovascular Research, and director of the Cardiovascular Prevention and the Cardiac Rehabilitation Institutes at Sheba...
Activating patient engagement to evolve AF care
Patient engagement is key to optimising outcomes in the treatment of atrial fibrillation (AF) argues Elana Arbelo (Consultant Cardiac Electrophysiologist and Community Cardiologist, Hospital...
Wearables offer “great potential” in AF screening but physicians cautious over...
Consumer wearables offer a great potential for the screening of atrial fibrillation (AF), however two thirds of healthcare professionals admit to concerns over mass...
Wearable devices: The new frontier in arrhythmia management?
“I believe, if you zoom out into the future, and you look back, and you ask the question, ‘What was Apple’s greatest contribution to...
Regular alcohol consumption linked to increased AF risk
A study of nearly 108,000 people has found that people who regularly drink a modest amount of alcohol are at increased risk of atrial...
Volta Medical secures €23 million in financing round
Volta Medical, a French health technology startup working on artificial intelligence (AI) algorithms to treat cardiac arrythmias, has announced that it has successfully raised...
ACC.21 to offer remote COVID-19 screening
The American College of Cardiology (ACC) is partnering with BioIntelliSense, a continuous health monitoring and clinical intelligence company, to advance remote patient monitoring (RPM)...
Warning over smartphone interference inhibiting ICD therapy
A letter published in the journal Heart Rhythm has warned of possible interference to implantable cardioverter defibrillator (ICD) therapy caused by magnets in the...
Jian’an Wang named as editor of JACC: Asia
Jian’an Wang (Heart Center, Zhejiang University, Hangzhou, China) has been named the inaugural editor-of-chief of JACC: Asia, a new journal from the American College...
High power CLOSE-guided PVI “increases procedural efficiency”
Results of a prospective randomised evaluation of using high power during CLOSE-guided pulmonary vein isolation (PVI) using the Thermocool Smarttouch (Biosense Webster) device—the POWER-AF...
Canadian approval for Medtronic’s Micra AV pacemaker
Medtronic Canada has received a Health Canada licence for Micra AV, the world's smallest pacemaker with atrioventricular (AV) synchrony. Micra AV is indicated for...
PRECAF study looks at elimination of distal coronary sinus to left...
Elimination of distal coronary sinus (CS) to left atrial (LA) connections reduced atrial arrhythmia recurrences compared to standard pulmonary vein (PV) isolation and non-PV...
ACC recommends against “triple therapy” in AF patients
The American College of Cardiology (ACC) has issued guidance recommending against triple antithrombotic therapy in patients with atrial fibrillation (AF), due to its increased...
Philips to acquire cardiac monitoring specialist BioTelemetry
Royal Philips has agreed a merger agreement with BioTelemetry, a cardiac monitoring company focused on the diagnosis and monitoring of heart rhythm disorders.
Philips will...
Abbott’s HeartMate 3 LVAD receives approval for paediatric use
Abbott has announced that the US Food and Drug Administration (FDA) has approved updated labelling for the company's HeartMate 3 heart pump to be...
US FDA clears vital data sensor in Biomonitor IIIm
Biotronik has today announced US Food and Drug Administration (FDA) clearance and availability of the Vital Data Sensor, which identifies body temperature increases potentially...
CardioFocus announces 10,000-patient milestone for HeartLight ablation system
CardioFocus has announced that more than 10,000 patients worldwide have been treated with the HeartLight endoscopic ablation system.
The HeartLight system is a catheter ablation...
Patient enrolment begins in Astral-4LV clinical trial
MicroPort Cardio Rhythm Management (CRM) has announced the first enrolment in the Astral-4LV clinical trial to evaluate the safety and efficiency of Axone, a...
European launch for Acutus Medical’s AcQCross transseptal crossing system
Acutus Medical has announced CE mark approval and the European launch of its integrated family of transseptal crossing products, designed to deliver safe and...
Volta Medical’s VX1 AI software for use in AF mapping now...
Volta Medical has announced that it has obtained US Food and Drug Administration (FDA) clearance for its VX1 AI (artificial intelligence) software. According to...
Biotronik receives CE mark for AICath Force ablation catheter
Biotronik has announced CE mark approval for the AlCath Force the gold-tipped force sensing ablation catheter system.
The AlCath Force was designed specifically to show...
Heavy alcohol consumption leads to higher stroke risk in AF patients
Fourteen drinks a week is linked with a higher risk of stroke and embolism in patients with atrial fibrillation (AF), according to research published...
Study compares WatchPAT to in-lab diagnosis of sleep apnoea in AF...
Itamar Medical has announced the publication of a study in the December 2020 edition of Nature and Science of Sleep validating the use of...
Acutus Medical launches the AcQBlate force sensing ablation system in Europe
Acutus Medical has announced the launch of the AcQBlate force sensing ablation system in Europe after securing CE mark for the company’s AcQBlate FORCE...
Cathy Gates named as ACC’s new CEO
Cathy Gates has been named as the new CEO of the American College of Cardiology (ACC), effective immediately. Gates has been serving as interim...
Anticoagulants fail to improve survival from COVID-19, Swedish study finds
The use of direct oral anticoagulants (DOACs) did not reduce the rate of hospitalisation, intensive care admission or fatality due to COVID-19, according to...
Zio XT cardiac monitor recommended for NICE guideline adoption
iRhythm Technologies has announced it is the first technology to pass through a new digital health tech pilot, resulting in a successful recommendation for...
Rhythm AI announces publication of STAR mapping study
Rhythm AI has announced publication of a human clinical outcome study for its Stochastic Trajectory Analysis of Ranked signals (STAR) mapping system in Circulation:...
AHA 2020: Active AF screening associated with significant improvement in clinical...
Three-year clinical outcomes of the mHealth Screening to Prevent Strokes—mSToPS—study evaluating silent, or previously undiagnosed, atrial fibrillation (AF) in moderate-risk individuals using Zio, the...
AHA 2020: AF detected more often in high risk patients recovering...
Atrial fibrillation (AF) was detected up to 10 times more frequently in high risk patients recovering from heart surgery who wore a continuous cardiac...
AHA 2020: Medtronic shares results of cryoablation studies
Medtronic has announced the presentation of results of three studies which it says demonstrate that cryoablation is superior to drug therapy for first-line treatment...
AHA 2020: InCarda announces presentation of INSTANT trial data
InCarda Therapeutics has announced the presentation of positive data from the open-label, dose-escalation Part A portion of the company’s multinational INSTANT Phase 2 clinical...
AHA 2020: Rivaroxaban may be comparable to warfarin for bioprosthetic mitral...
The primary results from the RIVER Trial—Rivaroxaban for Valvular Heart disease and Atrial Fibrillation—show that rivaroxaban is comparable to warfarin for patients with bioprosthetic...
Adagio closes US$42.5 million Series E financing
Adagio, developer of the intelligent Continuous Lesion Ablation System (iCLAS), has announced that it has closed a US$42.5 million Series E equity financing. Proceeds...
Kardium announces first clinical use of Globe Positioning System
Kardium has announced the first clinical use of the Globe Positioning System—a 3D mapping and navigation feature of its flagship product, the Globe Mapping...
Append Medical completes transcatheter implant-free LAA occlusion procedures
Append Medical, developer of the Appligator implant-free left atrial appendage (LAA) occlusion device, today announced completion of its first pre-clinical chronic procedures. The procedures...
AliveCor appoints Toby Cosgrove to board of directors
AliveCor has announced the appointment of Toby Cosgrove to its board of directors. For more than 13 years, through to 2017, Cosgrove served as...
HeartHero receives CE mark for automated external defibrillator device
HeartHero has announced that its automated external defibrillator (AED) device—known as Elliot—has received CE mark approval. In a press release, the company said that...
American Heart Association issues call for action on structural racism in...
Structural racism is a major cause of poor health and premature death from heart disease and stroke, according to a presidential advisory issued today...
AHA 2020: Higher level of fitness reduces atrial fibrillation risk
Higher fitness levels reduced the risk of developing atrial fibrillation (AF) by 30‒50% in a study of male, African American veterans, according to preliminary...
Study draws link between physician payments and device selection
Payments from device manufacturers to physicians are likely to have a bearing on device selection in patients receiving an implantable cardioverter defibrillator (ICD) or...
Procedural success comparable in CRT implants and upgrades
Rates of procedural success and complications were no different between de novo cardiac resynchronisation therapy (CRT) implantations and upgrades, a study published in JACC:...
European and Australian approvals granted for Abbott’s cardiac mapping system EnSite
Abbott has announced has announced the receipt of CE mark and approval in Australia for its EnSite X EP System, and is launching the...
Machine learning approach could detect drivers of atrial fibrillation
Researchers have designed a new machine learning-based approach for detecting atrial fibrillation (AF) drivers, small patches of the heart muscle that are hypothesised to...
Boston Scientific initiates CHAMPION-AF trial of Watchman FLX
Boston Scientific has initiated the CHAMPION-AF clinical trial to evaluate the safety and efficacy of the Watchman FLX left atrial appendage closure (LAAC) device...
ESC events to continue digitally in 2021, society announces
The European Society of Cardiology (ESC) has announced that its full portfolio of congresses, teaching courses and exams in 2021—including the ESC Congress 2021—will...
InCarda raises US$30 million through Series C financing
InCarda Therapeutics, has raised US$30 million through the first close of a Series C equity financing. The financing was led by an affiliate of...
MRI scans can be performed safely in non-MR ICDs, study finds
Magnetic resonance imaging (MRI) examinations can be performed safely in patients with non-MR compatible cardiac devices, including those who are pacemaker-dependent or have abandoned...
Research programme to probe causes of unexplained cardiac arrest
A research programme into understanding the underlying causes of unexplained cardiac arrest has received significant backing from the British Heart Foundation (BHF).
The four-year project,...
JACC journal series looks at impact of COVID-19 on cardiovascular health
The Journal of the American College of Cardiology (JACC) has issued a three-part focus seminar on COVID-19 in 2020 to address the complex relationship...
Conformal LAAC studies presented at TCT Connect 2020
Conformal Medical has announced positive clinical data from first-in-human studies performed in the USA and Czech Republic, following trials of its left atrial appendage...
High-risk surgery patients vulnerable to cardiovascular diseases
One in five high-risk patients undergoing major non-cardiac surgery will develop one or more heart complications within a year, according to research published today...
BMJ study proves efficacy of Coala Heart Monitor as part of...
Coala Life has announced the results of a late breaking trial on cryptogenic stroke patients. In the TEASE-study, recently published in the British Medical...
First patients treated with the Centauri pulsed electric field system
Galaxy Medical, a developer of pulsed electric field (PEF) technology, has announced that the first patients in the ECLIPSE-AF study were successfully treated with...
VivaLNK and AMPS partner on data-gathering from remote ECGs
VivaLNK and AMPS have partnered to advance remote patient monitoring (RPM) for clinical trials, combining AMPS’ continuous electrocardiogram (ECG) recording suite with VivaLNK medical...
Rhythm AI gets green light for ROCSTAR clinical trial
Rhythm AI has today announced that it has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to proceed with its...
Development of AF after CABG linked to higher risk of cerebrovascular...
Patients with postoperative atrial fibrillation (AF) after coronary artery bypass graft (CABG) surgery are at a higher risk of cerebrovascular accidents (CVAs) up to...
Catheter ablation linked to lower incidence of dementia in AF patients
People with atrial fibrillation (AF) have a reduced risk of dementia if they undergo catheter ablation to restore the normal rhythm of their heart,...
US FDA approves Biosense Webster’s Thermocool Smarttouch SF ablation catheter
Johnson & Johnson Medical Devices Companies has announced the US Food and Drug Administration (FDA) approval of Biosense Webster’s Thermocool Smarttouch SF ablation catheter...
First patient implanted with next-generation AngelMed Guardian system
AngelMed has announced the first implant of the next-generation AngelMed Guardian system as part of the ALERTS-Continued Access Study. The AngelMed Guardian is an...
Holographic ablation guidance system gains US FDA clearance
SentiAR has received US Food and Drug Administration (FDA) 510(k) clearance for its CommandEP system, the first holographic guidance system to be used during...
First patients in Europe treated with Biosense Webster Varipulse catheter
Johnson & Johnson has announced that Biosense Webster has enrolled and treated the first patients in its inspIRE clinical study in Europe. The study...
Shouvik Haldar announced as Heart Rhythm Congress programme director
Shouvik Haldar (London, UK) has been announced as the new A-A Heart Rhythm Congress programme director, following the decision by Kim Rajappan (Oxford, UK)...
Study finds over 2,000 excess cardiovascular deaths in England and Wales...
Research has identified 2,085 excess deaths in England and Wales linked to cardiovascular disease during the peak of the COVID-19 pandemic. On average, that...
Twin studies demonstrate the evolving S-ICD evidence-base
This advertorial has been sponsored by Boston Scientific
Two landmark studies have been published in 2020 following the use of subcutaneous implantable cardioverter defibrillator (S-ICDs)...
Low rate of arrhythmia in COVID-19 patients undergoing short-term hydroxychloroquine treatment
Short-term hydroxychloroquine treatment is not associated with lethal heart rhythms in patients with COVID-19 who are risk assessed prior to receiving the drug. That...
First patients enrolled in study of LINQ ICM to detect heart...
Medtronic has announced the first enrolments in the ALLEVIATE-HF clinical trial which will evaluate the ability of its Reveal LINQ insertable cardiac monitor (ICM)...
VivaLNK wearable ECG to be used in AF biomarkers study
VivaLNK has announced that the University of California, San Francisco (UCSF) (San Francisco, USA), will be utilising its continuous wearable electrocardiogram (ECG) sensor for...
Breakthrough status for Medtronic’s Tyrx for use with ventricular assist devices
Medtronic has received Breakthrough Device Designation status from the US Food and Drug Administration (FDA) for the Tyrx absorbable antibacterial driveline wrap, which is...
Boston Scientific to invest in pulsed field ablation device developer
Boston Scientific has signed an investment agreement with an exclusive option to acquire Farapulse, a privately-held company developing a pulsed field ablation (PFA) system...
US FDA approval for second generation AcQMap system
Acutus Medical has announces US Food and Drug Administration (FDA) 510(k) clearance of the second-generation AcQMap 3D imaging and mapping catheter which builds on...
Redesigning pathways to incorporate innovative technologies into primary care
Yassir Javaid (Northampton, UK) discusses the use of cloud-based technologies and machine learning to improve the treatment and detection of arrhythmias.
What potential is there...
Heart Rhythm Congress gears up for first digital-only event
Details of the digital format for the Arrhythmia Alliance’s Heart Rhythm Congress 2020 (27–30 September) have been released, with the event to be hosted...
Medtronic’s TYRX envelope found to be cost effective for patients at...
Medtronic has announced new data from the WRAP-IT study, showing the TYRX absorbable antibacterial envelope (TYRX Envelope) is cost effective for patients at increased...
CoreMap completes US$10.5 million financing round
CoreMap has announced the completion of a US$10.5 million Series A financing round led by Qure Ventures. The round included existing investors such as...
Air pollution exposure multiplies risk of stroke in AF patients
Sufferers of atrial fibrillation (AF) who are exposed to greater levels of pollution have a 1.2-fold higher risk of stroke than their peers who...
VitalConnect begins TELESTAR-TAVR remote monitoring study
VitalConnect has announced the commencement of the TELESTAR-TAVR clinical study—Deployment of Telemedicine for Symptom Tracking And Decrease Readmission Rate in TAVR Patients)—monitoring patients undergoing...
AHA calls for awareness of medication-induced arrhythmias
Healthcare professionals should become more familiar with medications that cause arrhythmias, according to a new scientific statement from the American Heart Association (AHA), published...
Stereotaxis robotic navigation systems installed in Phoenix and Helsinki
Stereotaxis has completed installations of the world’s first Genesis Robotic Magnetic Navigation (RMN) systems to treat heart rhythm disorders at Helsinki University Hospital in...
Arrhythmia Alliance launches online event for heart rhythm patients
Arrhythmia Alliance and its sister charities will launch the first virtual Patients Day on 27 September, with thousands of heart rhythm patients and healthcare...
Fitbit receives US and European approvals for ECG app to identify...
Fitbit has received 510(k) clearance from the US Food and Drug Administration (FDA), as well as Conformité Européenne (CE) marking in the European Union,...
Acutus announces pre-clinical results of a novel diagnostic workflow using its...
Acutus Medical has announced pre-clinical experimental results of a novel diagnostic and therapeutic workflow utilising the AcQMap system along with tissue-selective, non-thermal pulse field...
iRhythm wins AI award funding to trial Zio at NHS sites
iRhythm Technologies has been named a winner of the UK government’s Artificial Intelligence (AI) in Health and Care Award. The announcement was made by...
ACC announces revised dates for ACC.21
The American College of Cardiology (ACC) has announced that its 70th Annual Scientific Session, ACC.21 taking place in Atlanta, USA, will be held across...
Philips launches latest version of its Azurion imaging platform
Royal Philips has announced the next-generation of its Azurion image-guided therapy platform, designed to improve the quality and efficiency of interventional procedures. The Azurion...
ESC 2020 Congress: IMPACT-AFib finds no statistical difference in anticoagulant usage
A study investigating an educational intervention aimed at increasing the use of oral anticoagulants for stroke prevention among atrial fibrillation (AF) patients, found that...
Cardiologs and MicroPort CRM partner to offer AI-based ECG system in...
Cardiologs has announced an exclusive distribution agreement in France with MicroPort CRM, for the reselling of its cloud analysis solution for Holter electrocardiograms (ECGs)....
ESC 2020 Congress: Digoxin found to be favourable in rate control...
Digoxin should be considered as a first-line approach for rate control in patients with permanent atrial fibrillation (AF). This was the conclusion of the...
ESC 2020 Congress: AF associated with long-term mortality in primary PCI...
Atrial fibrillation (AF) is associated with long-term mortality in patients undergoing primary percutaneous coronary intervention (PCI), irrespective of left ventricular (LV) function, a study...
ESC 2020 Congress: Daiichi Sankyo announces results from ETNA-AF studies
Daiichi Sankyo Europe has announced one-year results of four sub-analyses from the European and global ETNA-AF (Edoxaban Treatment in routiNe clinical prActice in patients...
ESC Congress 2020: EAST-AFNET 4 finds early rhythm control improves AF...
Patients with newly diagnosed atrial fibrillation benefit from early rhythm control therapy, according to results of the EAST-AFNET 4 trial presented in a Hot...
ESC 2020 Congress: STOP AF First finds cryoballoon ablation safer than...
Cryoballoon catheter ablation as a first line treatment for paroxysmal atrial fibrillation (AF) was found to be safer and more effective than anti arrhythmic...
ESC Congress 2020: Guidelines push individualised approach to AF
Patients with arrhythmia should choose the treatment plan with their health professionals, according to European Society of Cardiology (ESC) guidelines published online today in...
Heart Rhythm Society publishes Cardiovascular Digital Health Journal
The Heart Rhythm Society has announced the publication of the inaugural issue of the Cardiovascular Digital Health Journal. The new journal focuses on the...
Biosense Webster launches latest generation of Carto heart mapping system
Johnson & Johnson Medical Devices Companies has today announced the launch of Biosense Webster’s Carto 3 system version 7 and the Carto Prime mapping...
Philips announces new imaging enhancements for Kodex-EPD system
Royal Philips has announced new imaging and workflow enhancements for its Kodex-EPD cardiac imaging and mapping system. The system is used to treat patients...
ESC Congress 2020: Smoking cessation linked to reduced stroke risk in...
Research presented at the ESC Congress 2020 (Virtual, 29 August–1 September) suggests that, among atrial fibrillation (AF) patients, those who quit smoking were 30%...
Low rates of bleeding and mortality reported in one-year results of...
Daiichi Sankyo Europe has announced the publication of one-year follow-up results from the ongoing ETNA-AF-Europe (Edoxaban Treatment in routiNe clinical prActice for patients with...
Digital platform takes 2020 ESC Congress to a wider audience
Ahead of the 2020 European Society of Cardiology (ESC) Congress, taking place from 29 August–1 September, the event’s scientific chair Marco Roffi (University Hospitals...
Using advanced imaging to tackle complex arrhythmias
J Peter Weiss (Heart Institute, Banner University of Arizona Medical Center, Phoenix, USA) outlines his experience of the AcQMap (Acutus Medical) 3D imaging and...
Biosense Webster receives CE mark approval for QDot Micro ablation catheter
Johnson & Johnson Medical Devices has today announced European CE mark approval of Biosense Webster’s QDot Micro radiofrequency (RF) ablation catheter.
According to a press...
Atrial fibrillation deaths “declining”, study finds
A study by researchers from the Boston University School of Public Health (BUSPH, Boston, USA) shows a decline in deaths related to atrial fibrillation...
First procedures performed in the USA using Watchman FLX LAAC device
Physicians at the Texas Cardiac Arrhythmia Institute (TCAI) at St David's Medical Center in Austin and Los Robles Health System in Thousand Oaks, became...
Fitness linked to lower arrhythmia recurrence after AF ablation
Patients undergoing atrial fibrillation (AF) ablation, who are physically fit before the procedure, have a much higher chance of benefiting from the procedure and...
JAHA retracts paper calling for end to cardiology diversity programmes
The Journal of the American Heart Association (JAHA) has retracted a paper published in March 2020, which drew criticism due to its conclusions about race and the role of affirmative action within...
Conformal Medical secures funding to support CLAAS device trial
Conformal Medical, a medical device company focused on reducing stroke in patients with atrial fibrillation (AF), today announced it has secured US$85 million in...
Integrated cardiac ablation performed using remote telerobotic system
Stereotaxis and Acutus Medical have announced the first integrated cardiac ablation procedure using remote TeleRobotic support. Gery Tomassoni of Baptist Health, Lexington, USA treated...
Eko and AstraZeneca announce digital cardiovascular health partnership
Eko has announced a collaboration with AstraZeneca to accelerate the development of digital health tools for the earlier screening of cardiovascular diseases, including heart...
Abbott begins IDE study of TactiFlex device for paroxysmal AF
Abbott has announced first enrolments in the TactiFlex PAF IDE study to evaluate a new device to treat people suffering from paroxysmal atrial fibrillation...
Adagio Medical reports pre-clinical success combining cryoablation catheter with pulsed field...
Adagio Medical, developer of the intelligent Continuous Lesion Ablation System (iCLAS), has announced successful pre-clinical results demonstrating its existing cryoablation catheter is also capable...
Prompt diagnosis “vital” in effective AF management
Dhiraj Gupta, consultant cardiologist and electrophysiologist at Liverpool Heart and Chest Hospital, (Liverpool, UK) discusses the current burden of atrial fibrillation (AF) on healthcare...
Mobile phones and smartwatches pose little risk of CIED interference
The risk of electromagnetic interference to cardiovascular implantable electronic devices (CIEDs) from smartwatches and mobile phones is low—although close proximity between an iPhone 6...
American College of Cardiology to launch JACC: Asia
The American College of Cardiology (ACC) is expanding its JACC family of peer-reviewed journals to include JACC: Asia, which will publish original manuscripts focused...
Holographic display may improve physician accuracy during cardiac ablation
Details of the first-in-human use of an augmented reality holographic display to aid physician accuracy during cardiac ablation have been published in the Journal...
Caption Health gains FDA approval for updates to its cardiac AI...
Caption Health, a developer of medical artificial intelligence (AI) technology, has received US Food and Drug Administration (FDA) 510(k) clearance for an updated version...
Funding secured to further study of AI systems for cardiovascular health
Digital health and artificial intelligence (AI) company Eko has been awarded a US$2.7 million Small Business Innovation Research (SBIR) grant by the National Institutes...
Next-generation Watchman LAAC device gains US FDA approval
Boston Scientific has received US Food and Drug Administration (FDA) approval for the Watchman FLX left atrial appendage closure (LAAC) device. The device is...
LifeSignals receives US FDA clearance for the ECG Remote Monitoring Patch
LifeSignals Group has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance for the LifeSignals ECG Remote Monitoring Patch platform.
The...
Women taking beta blockers for hypertension may have higher risk of...
Women taking beta blockers for hypertension with no prior history of cardiovascular disease have a nearly 5% higher risk for heart failure than men...
AHA Scientific Sessions 2020 to be held virtually
The American Heart Association (AHA) has announced that its 2020 Scientific Sessions will be presented as a 100% virtual experience in light of the impact...
ACC publishes pathway on the management of bleeding in patients on...
The American College of Cardiology has published an expert consensus decision pathway (ECDP) on the management of bleeding in patients being treated with direct...
Continuous electrocardiogram monitoring post-stroke patients uncovers AF in 4.6% of patients
Screening patients in a primary care setting over one year after occurrence of a stroke using seven-day Holter monitoring uncovered atrial fibrillation (AF) in 4.6%...
Paper highlights use of robotic system for catheter ablation in COVID-19...
Stereotaxis has announced the publication of a paper in the European Heart Journal highlighting the benefits of using robotic technology for the management of...
Lower rate of post-ablation arrhythmia recurrence found in patients with shorter...
Patients with atrial fibrillation (AF) episodes limited to less than 24 continuous hours had a significantly lower incidence of arrhythmia recurrence following AF ablation...
Athena Poppas
Athena Poppas is chief of cardiology at the Alpert Medical School of Brown University (Providence, USA) and has recently begun her term as the...
AliveCor launches KardiaCare subscription service
AliveCor has announced the launch of KardiaCare, a digital health subscription service offering digital tools to monitor heart data, risk factors, identify symptom triggers,...
US and European approval for Medtronic’s LINQ II insertable cardiac monitor
Medtronic today announced that it has received US Food and Drug Administration (FDA) clearance and CE mark approval for its LINQ II insertable cardiac...
Abbott receives US FDA approval for Gallant ICD and CRT-D devices
Abbott has announced that the US Food and Drug Administration (FDA) has approved the company's next-generation Gallant implantable cardioverter defibrillator (ICD) and cardiac resynchronisation...
€3.7m funding round completed for cardiac AI developer inHEART
inHEART, developer of a cloud-based medical image analysis solution for cardiac interventions on patients with arrhythmias, has closed a funding round of €3.7m led...
Carag Bioresorbable Septal Occluder approved for US IDE trial
US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval has been granted for the Carag Bioresorbable Septal Occluder (CBSO).
The CE-marked CBSO is...
Kardium receives CE mark for its Globe Mapping and Ablation System
Kardium has received CE mark approval for its Globe Mapping and Ablation System for the treatment of atrial fibrillation (AF).
“This is an important milestone...
PCR e-Course 2020: Roll-in trial finds high device success rate for...
Left atrial appendage occlusion (LAAO) using the Amplatzer Amulet (Abbott) device has a high implant success rate and a low procedural complication rate in...
PCR e-Course 2020: Left atrial appendage occlusion improves clinical outcomes versus...
Left atrial appendage occlusion (LAAO) improves clinical outcomes including ischaemic stroke, major bleeding and all-cause mortality, in atrial fibrillation (AF) patients with a high...
Tenfold risk of arrhythmias in intensive care COVID-19 patients
Patients with COVID-19 who were admitted to an intensive care unit were 10 times more likely than other hospitalised COVID-19 patients to suffer cardiac...
Philips receives FDA premarket approval for its HeartStart FR3 and HeartStart...
Royal Philips has announced that the Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA) has granted premarket...
Smartphone app can identify lung congestion in heart failure patients
Voice analysis by a smartphone app can identify lung congestion in heart failure patients, allowing early intervention before their condition deteriorates, a study presented...
Medtronic’s Micra AV TPS receives CE mark
Medtronic has received CE mark for Micra AV Transcatheter Pacing System (TPS), the world’s smallest pacemaker with atrioventricular (AV) synchrony.
Micra AV is indicated for...
First US patients treated using HeartLight X3 ablation system
CardioFocus has announced that the first patients have been treated commercially with the recently-approved HeartLight X3 endoscopic ablation system in the USA. The cardiac...
Biotronik announces initial launch of its His-Bundle Pacing tools
Biotronik has announced its commitment to giving physicians additional tools to pace in the His-Bundle, coinciding with the launch of its His-Bundle Pacing (HBP)...
Occupation: Influencer
Jeffrey L Turner, Brian Zenger and Benjamin Steinberg (all University of Utah School of Medicine, Salt Lake City), write that social media has become...
Societies publish consensus statement on risk assessment in arrhythmias
Global cardiac health societies have collaborated on a consensus statement on the diagnosis of arrhythmias, designed to provide physicians with practical proposals to improve...
Optical mapping used to assess effect of hydroxychloroquine on heart rhythm
Researchers have used an optical mapping system to observe how the malaria drug hydroxychloroquine, which has been touted as a possible treatment for COVID-19,...
Adagio Medical receives CE mark for iCLAS ablation system
Adagio Medical has received CE mark approval for its ultra-low temperature intelligent Continuous Lesion Ablation System (iCLAS) for the endocardial treatment of paroxysmal (PAF)...
Cardiologists plot “return to normal” as COVID-19 restrictions ease
As electrophysiologists worldwide begin the process of restarting elective procedures put on hold due to the COVID-19 pandemic, cardiology departments are braced for a...
Cardiac Rhythm News Issue 48 – May 2020
Highlights:
Cardiologists discuss the "return to normal" as COVID-19 restrictions ease
Late breaking trials from HRS 2020 Science including: PRAETORIAN, UNTOUCHED and PINNACLE FLX
...
Bardy Diagnostics receives CE mark for 14-day CAM patch
Bardy Diagnostics has received CE mark certification for the 14-day version of the Carnation Ambulatory Monitor (CAM) patch, the p-wave centric ambulatory cardiac patch...
Heart Rhythm Congress moves to virtual event for 2020
The 2020 edition of the Heart Rhythm Congress (HRC 2020), which had been scheduled to take place 27–30 September in Birmingham, UK, has been...
Lancet study finds no benefit in use of hydroxychloroquine for COVID-19
A study into the use of hydroxychloroquine or chloroquine, published in The Lancet, has failed to find a benefit in hospital-outcomes from the use...
Music triggers individualised cardiac response
Play the same piece of music to two people, and their hearts can respond very differently. That is the conclusion of a study presented...
Eko launches AI-powered telehealth platform for cardiac exams
Eko has announced the launch of Eko Telehealth, an artificial intelligence (AI)-powered telehealth platform for virtual cardiac and pulmonary monitoring. Being used by more...
Acutus Medical and Biotronik announce electrophysiology alliance
Acutus Medical and Biotronik have announced a new alliance to provide a comprehensive portfolio of electrophysiology, mapping, ablation and accessory products for catheter-based treatment...
AI-based ECG analysis reduces false positives in AF detection
Cardiologs, in partnership with the Valley Health System, has announced the results of a clinical study that found the Cardiologs AI-based ECG analysis solution...
Durablate catheter results demonstrate feasibility in VT ablation
Thermedical has announced that results from a first-in-human early feasibility study (EFS) using the Durablate catheter to treat ventricular tachycardia (VT) were presented in...
Philips gains FDA clearance for the use of its ultrasound portfolio...
Royal Philips has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market a wide range of...
The evolution of cardiac care in the wake of COVID-19
David E Albert, founder and chief medical officer of AliveCor, considers the impact of the COVID-19 pandemic on the monitoring and of management of...
FDA approves update to cardiac imaging system to aid COVID-19 diagnostics
The US Food and Drug Administration (FDA) has expedited clearance of an update to software from Caption Health, a medical artificial intelligence (AI) company,...
US FDA approval granted for HeartLight X3 endoscopic ablation system
CardioFocus has announced that the US Food and Drug Administration (FDA) has approved the next-generation HeartLight X3 endoscopic ablation system for the treatment of...
Medtronic receives US FDA approval for Cobalt and Crome implantable ICDs
Medtronic has received US Food and Drug Administration (FDA) approval for its Cobalt and Crome implantable cardioverter-defibrillators (ICD) and cardiac resynchronisation therapy-defibrillators (CRT-D).
ICDs monitor...
CONVERGE IDE trial results presented at HRS 2020 Science
AtriCure has announced results from the CONVERGE IDE clinical trial, which showed an 18% difference in favour of the hybrid Convergent procedure as compared...
HRS 2020 Science: UNTOUCHED study finds improved inappropriate shock rate using...
Findings from the UNTOUCHED study, presented online in a late-breaking trial session at HRS 2020 Science, showed that patients receiving subcutaneous implantable cardioverter defibrillator...
Medtronic shares results of BlueSync and Micra TPS CED studies
Medtronic has announced results from late breaking clinical trials, presented online at HRS 2020 Science, evaluating the MyCareLink Heart mobile app and the Micra...
Contact force sensing catheters “safe and effective” in persistent AF ablation
Contact force (CF) sensing catheters have been shown to be safe and effective in persistent atrial fibrillation (AF) ablation, according to the findings of...
Boston Scientific announces positive PINNACLE FLX study results
Boston Scientific has announced positive 12-month results from the PINNACLE FLX clinical trial assessing the safety and efficacy of the next-generation WATCHMAN FLX Left...
HRS 2020 Science: PRAETORIAN trial demonstrates non-inferiority of S-ICDS compared to...
Subcutaneous implantable cardioverter defibrillators (S-ICDs) are as protective as transvenous implantable cardioverter-defibrillators (ICDs) in the prevention of sudden cardiac death, but have a better...
Results of PULSED AF trial presented at HRS 2020 Science
Initial results of the PULSED AF trial, the first-in-human results for paroxysmal or persistent atrial fibrillation (AF) treated with pulsed field ablation (PFA) were...
Heart Rhythm Society launches white paper on AF centres of excellence
The Heart Rhythm Society (HRS) has released a white paper announcing the rationale and core components for Atrial Fibrillation (AF) centres of excellence (CoE),...
Fitbit to enrol patients in AF detection study
Fitbit has today launched the Fitbit Heart Study, its first large-scale, virtual study to validate the use of its wearable technology to identify episodes...
LifeSignals receives CE mark for the ECG Remote Monitoring Patch
LifeSignals has received CE mark approval for the LifeSignals ECG Remote Monitoring Patch, a disposable wireless remote monitoring system, intended for use by healthcare...
Sex and race disparities found in ICD interventions for cardiac patients
Results of a clinical trial show stark disparities in the use of life-saving implantable cardioverter defibrillator (ICD) interventions based on sex and race, suggesting...
VitalConnect granted Emergency Use Authorisation for cardiac monitoring in COVID-19 patients
VitalConnect has been granted Emergency Use Authorisation (EUA) status by the US Food and Drug Administration (FDA) as part of the response to the...
Study points to potential treatment for long QT syndrome
A study published in the Journal of the American College of Cardiology (JACC) provides the first direct evidence that KCNQ1 antibodies are able to...
Same-day discharge “feasible for majority of AF ablation patients”
Same-day discharge after atrial fibrillation (AF) ablation is feasible for the majority of patients when a standardised protocol is used, findings of a multicentre cohort study, published in the Journal of the American...
iRhythm offers home enrolment of Zio monitoring devices
iRhythm Technologies has announced a virtual platform to support patients and clinicians in the wake of COVID-19 by offering home enrolment for the company’s...
Coala Heart Monitor expands capabilities for monitoring COVID-19 patients
Coala Life has announced the expansion of capabilities to help monitor patients from home using the Coala Heart Monitor. This expansion is a result...
iRhythm makes board appointment
iRhythm Technologies has announced the appointment of Renee Budig to its Board of Directors effective 23 April 2020. Budig was appointed as a Class...
FDA advises close screening of COVID-19 patients receiving hydroxychloroquine
The US Food and Drug Administration (FDA) has issued a Drug Safety Communication regarding known side effects of hydroxychloroquine and chloroquine, including serious and...
Mobile telemetry can aid QTc monitoring of COVID-19 patients
The use of mobile cardiac outpatient telemetry (MCOT) can help monitor COVID-19 patients taking hydroxychloroquine and azithromycin, while reducing potential exposure to the virus...
Heart Rhythm Society provides further advice for using hydroxychloroquine to treat...
The Heart Rhythm Society (HRS) COVID-19 Rapid Response Task Force has updated its guidance on QTc monitoring in COVID-19 patients. In the revised guidance,...
EU-funded project to assess AF screening algorithm
The European Society of Cardiology (ESC) is participating in two large-scale EU-funded projects to detect heart rhythm disorders and prevent sudden cardiac death.
The first...
AI study launched to monitor cardiac safety of COVID-19 patients receiving...
Cardiologs has announced the launch of a clinical study using the company’s artificial intelligence (AI) solution to remotely monitor the cardiac safety of COVID-19...
Cardiac Insight launches Heart@Home ECG test kit
Cardiac Insight has announced the launch of the Heart@Home electrocardiogram (ECG) test kit to address new telehealth demands placed on cardiology practices by the...
Vivek Reddy joins DiNovA Medtech as chief medical advisor
DiNovA Medtech has announced that Vivek Reddy will join the company as chief medical advisor and co-founder of portfolio company Nuomao Medtech to lead...
Carnation Ambulatory Monitor patch used to detect arrhythmias in COVID-19 patients
Bardy Diagnostics has announced that its Carnation Ambulatory Monitor (CAM) Patch has been chosen for use in protocols to measure QT Segments in COVID-19...
US heart societies express concern over using hydroxychloroquine and azithromycin for...
Presidents of leading cardiac organisations, including the American Heart Association (AHA), the American College of Cardiology (ACC) and the Heart Rhythm Society (HRS), have...
Webinar: Cardiovascular specialists detail COVID-19 strategies
Cardiovascular specialists from across the globe shared current knowledge and key experience of managing COVID-19 patients as part of a webinar organised by the...
AHA issues oxygenation and ventilation guidance for healthcare providers
The American Heart Association (AHA), in conjunction with the American Association for Respiratory Care (AARC) and American Society of Anesthesiologists (ASA) is offering guidance...
Heart Failure 2020 in Barcelona cancelled
The Heart Failure Association (HFA) of the European Society of Cardiology (ESC) has announced that Heart Failure 2020 & the World Congress on Acute...
Athena Poppas begins ACC presidency
Athena Poppas (Providence, USA) is the new president of the American College of Cardiology (ACC). Her term officially began at the close of the...
HRS 2020 in San Diego cancelled due to COVID-19 concerns
Due to COVID-19 concerns and travel restrictions, the 2020 Heart Rhythm Scientific Sessions (HRS 2020) will not take place in San Diego, USA, on...
Virtual ACC: Mavacamten “promising” in treatment of non-obstructive hypertrophic cardiomyopathy
Results from the phase 2 MAVERICK-HCM clinical trial, presented at the American College of Cardiology/World Congress of Cardiology’s virtual scientific sessions (ACC.20/WCC Virtual) suggest that...
Virtual ACC: LivaNova highlights Vitaria data
Data on the use of LivaNova’s implantable neuromodulation technology, Vitaria, for heart failure patients has been shared at the American College of Cardiology/World Congress...
Virtual ACC: Ethanol infusion in vein of Marshall improves catheter ablation outcomes
The infusion of ethanol via the vein of Marshall (VOM), coupled with catheter ablation, leads to improved outcomes for patients with persistent atrial ablation, according to the findings of a study presented by...
AHA commits US$2.5 million for fast-tracked COVID-19 heart and brain research
The American Heart Association (AHA) has committed US$2.5 million to research efforts to better understand the novel coronavirus, COVID-19, and its interaction with the...
Funding round for developer of wrist-mounted blood pressure monitor
Aktiia, a Swiss-US start-up that has developed an optical blood pressure monitor at the wrist, has raised an additional CHF 6 million in funding...
Study recommends “widespread adoption” of CVC for CIED implantation
Cephalic vein cutdown (CVC) and axillary vein access (AVA) are both effective approaches for cardiac implantable electronic device (CIED) lead implantation, and could avoid...
Stereotaxis receives FDA clearance for Genesis Robotic Magnetic Navigation system
Stereotaxis has received US Food and Drug Administration (FDA) 510(k) clearance for the Genesis Robotic Magnetic Navigation (RMN) system for the robotic navigation of...
Focus on the Zio Patch wearable sensor in diagnosis of cardiac...
James Teo was the chief investigator in the EPACS clinical trial, testing the performance of the Zio Patch (iRhythm Technologies) wearable biosensor. He outlines...
EHRA 2020 to feature late-breaking arrhythmia studies
Twenty late-breaking trials, including major clinical studies on the treatment of atrial fibrillation (AF) are among the research to be presented at the annual...
Kalyanam Shivkumar named as editor-in-chief of JACC: Clinical Electrophysiology
Kalyanam Shivkumar has been named the next editor-in-chief of the Journal of the American College of Cardiology (JACC): Clinical Electrophysiology.
Shivkumar is a physician scientist...
Wearable sensor analytics platform predicts worsening heart failure prior to hospitalisation
Wearing an adhesive patch sensor that streams data to an analytical platform can accurately predict worsening heart failure (HF) and the need for hospitalisation...
Append Medical shares clinical proof-of-concept results for internal sealing of LAA
Append Medical, developer of the Appligator, a novel left atrial appendage (LAA) closure device to minimise stroke risk in atrial fibrillation (AF) patients, and...
Abbott receives CE mark approval for Gallant ICD and CRT-D devices
Abbott has announced that it has received CE mark approval for the Gallant implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices.
The...
One in three patients treated in line with ICD guidelines
A study of patients undergoing implantable cardioverter defibrillator (ICD) therapy across three centres, found that only one in three were treated in concordance with...
VitalConnect adds arrhythmia detection to its remote monitoring software
VitalConnect has announced the introduction of arrhythmia detection to its remote monitoring portfolio. In partnership with CorVitals, VitalConnect now offers physicians the ability to...
ACC partners with AED device company for cardiac arrest alliance
The American College of Cardiology (ACC) and automated external defibrillator (AED) technology start-up HeartHero have formed an alliance aimed at making a “significant impact”...
AI-guided cardiac imaging system given FDA authorisation
The US Food and Drug Administration (FDA) has authorised marketing of software to assist in the acquisition of cardiac ultrasound, or echocardiography, images. The...
CardioFocus submits HeartLight X3 PMA application to FDA
CardioFocus has submitted a pre-market approval (PMA) supplement to the US Food and Drug Administration (FDA) for the HeartLight X3 Endoscopic Ablation System for...
Value of augmented reality goes well beyond holograms in the electrophysiology...
Jennifer Silva (St Louis, USA) talks to BLearning Cardio at SIR 2019 (Society of Interventional Radiology; 23–28 March; Austin, USA) about why physicians should...
Medtronic receives CE Mark for Cobalt and Crome implantable ICDs
Medtronic has received CE Mark for its Cobalt and Crome portfolio of implantable cardioverter-defibrillators (ICDs) and cardiac resynchronisation therapy-defibrillators (CRT-D). ICDs monitor heart rhythms...
Eko receives FDA clearance for AF and heart murmur algorithms
Eko has announced that the US Food and Drug Administration (FDA) has cleared a suite of algorithms that, when combined with Eko’s digital stethoscopes,...
AF Symposium 2020: Acutus Medical live streams case using AcQMap System
Acutus Medical offered a demonstration of its AcQMap advanced cardiac imaging and mapping system at AF Symposium (23–25 January, Washington, DC, USA) with a live-stream...
Medtronic gains FDA approval for PulseSelect trial
Medtronic has received approval from the US Food and Drug Administration (FDA) to proceed with an investigational device exemption (IDE) trial to evaluate the...
BardyDx announces commercial launch of the 14-day CAM Patch
Bardy Diagnostics (BardyDx) has today announced the commercial launch of the 14-Day version of the Carnation Ambulatory Monitor (CAM), the P-wave centric ambulatory cardiac...
Biotronik announces Japanese launch of injectable cardiac monitor
Biotronik has announced the market release of its injectable cardiac monitor (ICM), BioMonitor III in Japan. The device is designed to help patients with...
Hypocapnia could aid ablation of cardiac arrhythmias
A technique that enables patients suffering from heart conditions to hold their breath safely for over five minutes could have potential as a treatment...
AI and its growing role in arrhythmia
Malcom Finlay (Bart's Health Centre, London, UK) reviews the growing role of artificial intelligence (AI) in diagnosing arrhythmias.
Johnny, a 72-year-old film producer, is meeting...
Medtronic receives FDA approval for Micra AV
Medtronic has announced that it has received US Food and Drug Administration (FDA) approval of Micra AV, the world’s smallest pacemaker with atrioventricular (AV)...
CardioFocus appoints Burke T Barrett as chief executive
CardioFocus, has announced that the company’s board of directors has promoted Burke T Barrett to the position of chief executive officer (CEO), effective January...
First patient enrolled in PREDICT-LAA clinical trial
FEops has announced that the first patient has been enrolled in the physician-initiated PREDICT-LAA trial.
The trial is led by Righshospitalet (Copenhagen, Denmark) and aims...
Cardiac Rhythm News Issue 47 – January 2020
Highlights:
WRAP-IT shows significant mortality risk with CIED infection, and reduced quality of life
Sequential approach using STAR mapping system identifies key early sites...
Leading electrophysiologists identify four key studies that will shape arrhythmia treatment...
Leading electrophysiologists have pinpointed four clinical studies due to report findings in 2020—AMULET IDE, aMAZE IDE, PULSED AF and CEASE AF—that they expect to...
Persistent atrial fibrillation—seeking the sources of the cardiac electrical field
Andrew Grace charts the evolution of non-contact mapping culminating in the current AcQMap system—the technology has advanced understanding of persistent atrial fibrillation (AF), providing...
Eric N Prystowsky
Eric N Prystowsky (director of the Cardiac Arrhythmia Service at St Vincent Hospital, Indianapolis, and a consulting professor of medicine at Duke University Medical...
NICE recommends use of Reveal LINQ implantable cardiac monitor
The UK National Institute for Health and Care Excellence (NICE) has issued draft guidance recommending the use of the Reveal LINQ (Medtronic) implantable cardiac...
Ed Vertatschitsch joins Bardy Diagnostics as chief operating officer
Bardy Diagnostics (BardyDx) has announced today the appointment of Ed Vertatschitsch as chief operating officer. Effective 2 January 2020, the appointment will see Vertatschitsch...
ACC makes senior staff appointments
The American College of Cardiology (ACC) has announced several promotions and structural changes within its senior staff. The College said that the staff changes...
Stryker launches voluntary field action for LIFEPAK 15
Stryker has launched a voluntary field action on specific units of the LIFEPAK 15 monitor and defibrillator.
In an announcement issued by the company on...
AtriCure announces completion of enrolment for aMAZE clinical trial
AtriCure has announced the successful completion of patient enrolment in the aMAZE clinical trial. In addition, the company announced that it has received approval...
FDA grants Breakthrough designation for ECG-based algorithm
The US Food and Drug Administration has granted Breakthrough Device designation to the digital health and artificial intelligence (AI) company Eko for an echocardiogram...
European trial data ‘reinforce’ safety profile and efficacy of Lixiana
Daiichi Sankyo Europe has announced outcomes from an observational study in mainly caucasian atrial fibrillation (AF) patients being treated with the anti-coagulation drug edoxaban...
First patients treated in robotic arrhythmia care programme at Overland Park...
Stereotaxis announced today that HCA Midwest Health has launched a new robotic arrhythmia care programme based at Overland Park Regional Medical Center (OPRMC). Installation...
FDA panel votes against approval of AF drug Brinavess
The US Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted not to recommend approval for the anti-arrhythmic drug...
Impulse Dynamics secures funding to commercialise Optimizer Smart
Impulse Dynamics has announced the completion of a US$80.25 million Series D financing round with new investors. Proceeds will be used primarily to facilitate...
Tackling focal VT may improve catheter ablation in structural heart disease
Uncovering and abolishing focal ventricular tachycardia (VT) may further improve outcomes of catheter ablation in the treatment of structural heart disease, a study published...
VivaLnk’s multi-vital wearable sensor and software development kit receive CE mark
VivaLnk has announced it has received the class IIa medical device CE mark for its multi-vital medical wearable sensor and software development kit (SDK).
The...
PADIT score predicts CIED infection risk
Five independent predictors of cardiac implantable electronic device (CIED) infection have been identified which could be used to aid physicians and patients in decision-making...
Pedro Brugada
With his brothers Josep and Ramon, Pedro Brugada discovered the syndrome that bears their name. He reflects on his career highlights with Cardiac Rhythm...
AHA 2019: Correvio announces new data from SPECTRUM Brinavess study
Correvio announced the presentation of new data from the SPECTRUM study evaluating Brinavess (vernakalant hydrochloride, IV), an antiarrhythmic drug for the rapid conversion of...
Cardiac Rhythm News Issue 46 – October 2019
Highlights:
ESC guidelines on supraventricular tachycardias underline the pivotal role of catheter ablation therapy
Study suggests increased use of DOACs in AF leads to...
Left atrial appendage closure associated with a decreased stroke risk in...
Left atrial appendage closure (LAAC) via implanted device was associated with a decreased risk of admission for stroke, compared with the expected risk without...
First patients treated using integrated navigation technology from Stereotaxis and ADAS...
Stereotaxis and ADAS 3D Medical have announced that the first patients have been treated with the integration of ADAS 3D’s advanced preoperative substrate mapping...
CardioFocus treats first patients with HeartLight endoscopic ablation system in France
CardioFocus has announced that the first patients in France have been treated in the University Public Hospital of Nancy with the HeartLight endoscopic ablation...
Cardiva Medical announces publication of data from AMBULATE pivotal study
Cardiva Medical has said that results from the AMBULATE pivotal study demonstrate the safety and efficacy of its VASCADE MVP venous vascular closure system...
Bardy Diagnostics wins digital health pitch session at ESC Congress
Bardy Diagnostics announced that it was selected as winner of the ‘Remote Monitoring in Arrhythmias’ Technology and Innovation Pitch Session held as part of...
Low bleeding and cardiovascular events in elderly NVAF patients using edoxaban,...
Daiichi Sankyo has announced one-year follow-up results from an analysis of 12,574 European non-valvular atrial fibrillation (NVAF) patients, mostly elderly, treated with edoxaban (Lixiana)....
Haran Burri
During his studies Haran Burri was fascinated by the simplicity of an ECG providing a vast amount of information on cardiac functions. This drew...