One of the key proposals the MHRA seeks feedback on is the ‘indefinite recognition’ of EU CE-marked medical devices in the UK.

Lumea’s Viewer+™ software is now CE marked under IVDR for clinical use across Europe, making Lumea the most versatile ...

Medtronic (NYSE: MDT) announced today that it received CE mark for its ColonPRO fourth-generation software for AI-assisted colonoscopy.

Q4 2025 Management View CEO Paul LaViolette stated that Pulse Biosciences is “creating a pulsed field ablation platform to completely shift how physicians treat disease” by advancing nanosecond pulsed ...

CentoCloud, CENTOGENE’s cloud-based Software as a Service (SaaS) platform, is CE-marked under the In Vitro Diagnostics Directive (98/79/EC) CE-marking is required for all in vitro diagnostic (IVD) ...

PARIS, July 28, 2025--(BUSINESS WIRE)--Regulatory News: CARMAT (FR0010907956, ALCAR), designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic ...

The Medicines and Healthcare products Regulatory Agency (MHRA) is hoping to address a critical regulatory issue for medical ...

First-and-only test of its kind approved under new European Union regulations expands access to personalized cancer care for patients across the EU This in vitro diagnostic (IVD) assay, which has been ...

PARIS, Dec. 15, 2025 /PRNewswire/ -- AZmed, one of the leading companies in artificial intelligence (AI) for radiology, announced today the CE marking of AZnod, its first AI tool for computed ...