Highlife SAS secured CE mark for its transcatheter mitral valve replacement (TMVR) system, bringing a much needed treatment ...

A PDA requiring treatment is present in approximately 20% of premature infants 1 ABBOTT PARK, Ill., Dec. 18, 2025 /PRNewswire/ -- Abbott (NYSE: ABT) today announced it has received U.S. Food and Drug ...

Femasys Inc. announced the achievement of CE mark certification for the FemBloc delivery system, marking it as the first regulatory approval in the world for a non-surgical permanent birth control ...

The CE Mark enables the commercial distribution of Mobility+ ® Enteral Feeding System throughout the European Union and other CE-recognizing markets. The Mobility+ ® Enteral Feeding System is the ...

Varian’s Halcyon and Ethos radiotherapy systems received two regulatory nods in short succession, with both U.S. FDA 510(k) clearance and CE marking. In addition, the company reported that the first ...

Several years into the process of rectifying potential breaches in the sterile packaging of its life support systems—a process that has been littered with field correction notices and FDA-rated ...

Since the European Union’s main aims include consumer protection and ensuring product safety, you might be forgiven for thinking that the EU’s rules in those areas would be clear and straightforward.

Cerus’ Notified Body, TÜV-SÜD, has completed the review of the clinical module for the CE Mark submission for INTERCEPT Red Blood Cells (RBCs) CONCORD, Calif.--(BUSINESS WIRE)-- Cerus Corporation ...

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