Tag: FDA approval

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 Amgen

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...
Cardiac Rhythm news for specialists

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...