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

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 ...

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 ...

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 ...

Research indicates that non-shockable cardiac arrest is associated with higher mortality rates compared to cardiac arrest cases wherein shockable rhythms such as ventricular fibrillation or pulseless ...

BrightH eart, a global leader in AI-driven prenatal ultrasound, today announced it has received the CE mark for its flagship medical devices, enabling commercialization of the B-Right AI Platform ...

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 ...

Developed, tested, and selected from more than 200 formulations Unique long-chain chemistry formulated and optimized for 3D printing Pioneers a same-day digital denture solution with three times the ...