Senseonics (NYSE:SENS) announced today that its Eversense 365 continuous glucose monitor (CGM) system received CE mark ...

Medtronic announced two new milestones for its Affera Sphere-360 catheter for pulsed field ablation (PFA) procedures.

GE HealthCare has gained 501(k) clearance from the US Food and Drug Administration (FDA) for its CleaRecon DL technology, as well as a European CE Mark. An AI-based technology for improving the ...

HighLife announced today that it received CE mark approval for its transcatheter mitral valve replacement (TMVR) system.

Add Yahoo as a preferred source to see more of our stories on Google. Abbott’s range of paediatric heart treatments also includes the Masters HP 15mm mechanical heart valve. Credit: Michael Vi / ...

Certification opens the European market for the first FDA-cleared AI platform for prostate MRI interpretation. OMAHA, Neb., Oct. 27, 2025 /PRNewswire/ -- Bot Image, Inc., a leader in AI-powered ...

Paris, France and Cambridge, Massachusetts-based Voluntis, which makes companion software for medical devices or medications, has received both FDA clearance and the CE Mark for a type 2 diabetes ...

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 ...

Rockfield Medical Devices Limited Receives CE Mark Approval for the Mobility+® Enteral Feeding System, Marking a Major Milestone in Global Commercial Expansion ...