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

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

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

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 ...

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 ...

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, ...

With approval, the HeartMate 3 System offers physicians in Europe the most advanced ventricular assist technology available to support the management of patients with advanced stage heart failure ST.

NEUCHATEL, Switzerland--(BUSINESS WIRE)--Masimo (NASDAQ: MASI) announced today the CE marking of Next Generation SedLine ® brain function monitoring for pediatric patients (1-18 years of age). With ...