Tag: Medical devices

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...

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...

Swiss parliament votes to accept FDA-approved medical devices

The Swiss Federal Assembly has voted in favor of accepting medical devices with the Food and Drug Administration (FDA) marketing authorization in Switzerland. A motion...

CX Aortic Vienna: Onus on industry to meet clinician desire for...

The need for vascular companies to home in on developing longer-lasting devices—perhaps even ones that adapt over time to match patients’ changing anatomies—was underscored...

SCVS 2022: ‘We should not allow our industry relationships influence how...

Industry players and device makers have helped spark new science and innovation in vascular surgery amid flatlining National Institutes of Health (NIH) funding, but...

FDA issues guidance documents for including patient perspectives in medical device...

The Food and Drug Administration (FDA) has issued two final guidances providing recommendations for including patient perspectives in medical device clinical studies.   As per...

VQI partners with Symmetric Health Solutions to improve device identification accuracy

The Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) has announced a partnership with Symmetric Health Solutions aimed at elevating the consistency and...

Robert W Gore, inventor and chairman emeritus of WL Gore &...

Robert W. "Bob" Gore, PhD, the man behind expanded polytetrafluoroethylene (ePTFE) and chairman emeritus of the W.L. Gore & Associates board of directors, has...

Regulatory unity can help drive medical device adoption globally, FDA official...

LAS VEGAS—Efforts at international collaboration across borders can drive harmony among disparate regulatory requirements and lead to greater global cooperation at the medical device...