Vivasure Medical announced today that it received CE mark approval for its PerQseal Elite vascular closure system.

The regulatory approval in the EU comes approximately six months after Novocure secured FDA approval of the system.

Edwards Lifesciences has received CE marking for its transfemoral transcatheter mitral valve replacement system, setting up ...

You can no longer expect users to figure out PDE security for themselves or hope that you can shift responsibility to your ...

The replacement system is launching into markets already served by repair devices, namely Edwards’ Pascal and Abbott’s ...

Receipt of EU MDR CE mark may not be a magic potion, but Elixir Medical Corp. is certainly feeling a boost from the regulatory nod for its mechanical Lithix hertz contact intravascular lithotripsy ...

Abbott's Volt™ PFA System is designed to provide a new therapy option for people battling heart rhythm disorders such as atrial fibrillation Pulsed field ablation – or PFA – uses high energy ...

After acquiring its developer last year, Edwards Lifesciences has now obtained a European approval for what it described as ...

Edwards Lifesciences (EW) announced the company’s Sapien M3 mitral valve replacement system received CE Mark for the transcatheter treatment of ...

IRVINE, Calif.--(BUSINESS WIRE)--Edwards Lifesciences Corporation (NYSE: EW) today announced the company’s SAPIEN M3 mitral valve replacement system received CE Mark for the transcatheter ...

Edwards Lifesciences has received Europe’s CE mark for its transcatheter mitral valve replacement system, Sapien M3, the company said Monday. The device is designed for people with symptomatic ...