Tag: FDA
US FDA seeks to “modernise” clinical trials with new draft guidance
The US Food and Drug Administration (FDA) has released draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernising the design...
MicroPort receives FDA approval for latest range of implantable pacemakers
MicroPort, a global developer in the field of cardiac rhythm management, announced today it has received US Food and Drug Administration (FDA) approval for...
FDA issues two final guidances for including patient perspectives in medical...
The US Food and Drug Administration (FDA) has issued two final guidances providing recommendations for including patient perspectives in medical device clinical studies.
As...
CDRH adjusts working practices with medical device companies to deal with...
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has written to the medical device industry to outline its...
Medtronic releases MARVEL 2 data on leadless pacing in AV block
Medtronic has announced results from the MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study. A press release from the company says that...
FDA grants Fast-Track designation to develop heart failure drug
The US Food and Drug Administration (FDA) has granted Fast Track designation for the development of dapagliflozin (Farixga, AstraZeneca) to reduce the risk of...
FDA grants Breakthrough Device Designation for the WiSE CRT
EBR Systems has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its WiSE cardiac resynchronisation therapy (CRT)...
Scott Gottlieb resigns as head of US FDA
The commissioner of the US Food and Drug Administration (FDA), Scott Gottlieb, has unexpectedly resigned after serving just shy of two years in the...
US government shutdown disrupting FDA work
The US government shutdown means the country’s Food and Drug Administration (FDA) cannot accept new user fees, which means the agency cannot accept new...
US FDA plan shakeup of its 510(k) clearance programme
The US FDA has announced plans to modernise its 510(k) clearance programme for approving medical devices for the US market. Data show that about...
US FDA issues draft guidances for recommended premarket testing and labelling...
The US Food and Drug Administration (FDA) released the following two draft guidance documents: These guidance documents provide industry and FDA staff with recommendations on...
FDA classifies HeartWare HVAD systems unexpected power source switching as Class...
The United States Food and Drug Administration (FDA) has classified Medtronic recent voluntary urgent field action related to the HeartWare HVAD System unexpected power...
Battery performance alert and cybersecurity firmware updates for certain Abbott implantable...
The US FDA has approved a firmware update that is now available and is intended as a corrective action (recall), to reduce the risk...
Medtronic: class I recall- manufacturing error preventing electrical shock delivery
Medtronic is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT-Ds) due to a defect in the manufacturing process. This defect...
Clarithromycin (Biaxin): potential increased risk of heart problems or death in...
The FDA is advising caution before prescribing the antibiotic clarithromycin (Biaxin) to patients with heart disease because of a potential increased risk of heart...
New FDA approvals for Abbott’s MRI-ready devices
Abbott has announced the US Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labelling for the Quadra Assura MP cardiac resynchronisation therapy...
Medtronic HeartWare HVAD approved for destination therapy
The US Food and Drug Administration (FDA) has approved Medtronic’s HeartWare HVAD system as a destination therapy for patients with advanced heart failure who...
US FDA bans powdered gloves
The US Food and Drug Administration (FDA) has issued a final rule to ban powdered surgical gloves, patient examination gloves and the absorbable powder...
NICE collaborates with US FDA on Payer Communication Taskforce
The UK’s National Institute for Health and Care Excellence (NICE) has announced its participation in the US Food and Drug Administration (FDA)’s Payer Communication...
Fewer cardiovascular drugs being studied in clinical trials
The number of cardiovascular drugs in the research pipeline has declined across all phases of development in the last 20 years—even as cardiovascular disease...
US FDA approves Boston Scientific Emblem MRI S-ICD system
Boston Scientific has received US Food and Drug Administration (FDA) approval for the Emblem MRI subcutaneous implantable defibrillator (S-ICD) system, as well as magnetic...
US FDA clears expanded paediatric indication for Itamar Medical WatchPAT device
Itamar Medical has received US Food and Drug Administration (FDA) clearance to expand the medical indication of WatchPAT for sleep apnoea diagnosis. WatchPAT is...