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 ...

With CE mark approval, the pulsed field ablation procedure becomes available to treat patients in Europe with persistent atrial fibrillation.

PCOS affects between 10% and 13% of women worldwide. Image credit: Toey Andante via Shutterstock.com. France-headquartered May Health has secured a European CE mark for its Anavi system to address ...

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 ...

As previously announced, the UK government has enacted legislation to continue the recognition of the CE marking indefinitely for a range of products falling within the scope of 21 regulations, ...

Only a month after Getinge announced the suspension of the CE marks allowing it to sell its heart-lung support and permanent life support systems in Europe, the Swedish devicemaker has temporarily ...

Add Yahoo as a preferred source to see more of our stories on Google. CMR Surgical is based in Cambridge, United Kingdom. (Courtesy of CMR Surgical) This story was originally published on MedTech Dive ...

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

PARIS & SAN FRANCISCO--(BUSINESS WIRE)--Moon Surgical, a French-American pioneer in collaborative robotics, announced today that the latest version of its Maestro System is CE Marked under the Medical ...

SAN DIEGO, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Beam Global, (Nasdaq: BEEM), a leading provider of innovative and sustainable infrastructure solutions for the electrification of transportation and energy ...

The European Commission is working on a proposed revision of the New Legislative Framework (NLF) for CE-marked products, with plans to use this as a vehicle to roll out requirements for digital ...