Tag: FDA approval
Luma Vision receives US FDA clearance for Verafeye 2D/4D cardiac visualisation...
Luma Vision has announced the US Food and Drug Administration (FDA) clearance of its Verafeye visualisation platform.
As per a company press release, this...
US FDA grants Medtronic approval for extravascular defibrillator to treat abnormal...
Medtronic has received US Food and Drug Administration (FDA) approval for the Aurora EV-ICD MRI SureScan (extravascular implantable cardioverter-defibrillator) and Epsila EV MRI SureScan defibrillation...
Swiss parliament votes to accept US FDA-approved medical devices
The Swiss Federal Assembly has voted in favour of accepting medical devices with US Food and Drug Administration (FDA) marketing authorisation in Switzerland.
A motion...
Abbott announces trial to assess new therapy option for stroke
Abbott has announced approval from the US Food and Drug Administration (FDA) for the CATALYST trial to examine its Amplatzer Amulet device compared to...
FDA approves Abbott heart pump for less invasive surgical approach
Abbott has announced US Food and Drug Administration (FDA) approval of a new alternative surgical technique for Abbott's HeartMate 3 heart pump that the...
FDA approval granted for VASCADE MVP system
Premarket Approval (PMA) from the US Food and Drug Administration (FDA) has been granted for the VASCADE MVP Venous Vascular Closure System (Cardiva Medical)....
Evolocumab becomes first FDA-approved PCSK9 inhibitor for prevention of MI and...
Following a priority review by US Food and Drug Administration (FDA), evolocumab has received FDA approval in the USA. The drug is a PCSK9...
Central sleep apnoea treatment device remedē receives FDA approval
Respicardia has received US Food and Drug Administration (FDA) approval of its remedē system, a transvenous implantable neurostimulation device that stimulates the phrenic nerve and...
Analysis of LAA closure devices reveals post-approval spike in safety events
A retrospective study conducting a safety assessment and comparison between two percutaneous devices commonly used for left atrial appendage (LAA) closure in the US...
Acutus Medical receives FDA clearance for AcQGuide Steerable Sheath
Acutus Medical has announced the FDA clearance of the AcQGuide Steerable Sheath, which marks the first US regulatory milestone for the company. The AcQGuide Steerable...