IVDR compliance is a critical milestone not only for regulatory readiness, but for the long-term sustainability of ...

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 ...

The MEVION S250-FIT is the first and only proton therapy system designed to fit into a standard radiation therapy vault. By enabling cancer centers to use their existing infrastructure, the MEVION ...

The UPC has granted a preliminary injunction effective for Germany, France, Italy, the Netherlands and Ireland against a Chinese medical device manufacturer and its Dutch subsidiary over the ...

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 ...

IRVINE, Calif.--(BUSINESS WIRE)--Telesair, Inc., an innovator of next generation respiratory technology, announced today that it has received CE (Conformité Européenne) Marking under the European ...

Edwards Lifesciences has received CE marking for its transfemoral transcatheter mitral valve replacement system, setting up market rivalry with Abbott. Edwards’ device, dubbed Sapien M3, is the first ...

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 ...

In January 2026, the ERC reaffirmed that CE marking via ETA should be the reference route for placing GFRP reinforcing bars on the European market. The objective is clear, remove technical barriers to ...

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

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