The CE marking by GMED recognises compliance with patient safety and clinical efficacy for Class IIb devices.

This article will examine market access outside the EU/EEA based on reliance and recognition. For countries outside the European Union (EU) and European Economic Area (EEA), regulatory reliance and ...

The decision was based on findings from the Phase III PANOVA-3 clinical trial.

Valgen Medtech announced today that it received CE mark approval for its DragonFly transcathteter mitral repair system.

AorticLab announced today that its FLOWer device received CE mark approval for extended use in transcatheter cardiovascular ...

This authorisation will expand the B-Right AI platform’s use to Europe, as BrightHeart continues to roll the technology out ...

With the ever-increasing stringency, time, and expense associated with FDA approval for medical devices, debate is sharpening in the medical devices industry over whether it is actually better ...

PARIS--(BUSINESS WIRE)--Regulatory News: CARMAT (FR0010907956, ALCAR), designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for ...

Spotlight Medical, a Paris-based oncology diagnostics company, today announced that myStage Dx has received CE marking under the European Union In Vitro Diagnostic Medical Devices Regulation (IVDR, ...

European marketing authorization follows U.S. FDA clearance of eyonis LCS, Median's AI-based Software as a Medical Device designed to aid in the detection and diagnosis of lung cancer in screening ...