Overture’s DaVitri system aims to make egg thawing and freezing processes during IVF more consistent to improve successful ...

(click to enlarge)Average total FDA review days from filing to approval for original PMAs and panel track PMA supplements. Some of these products can now be reviewed for marketing in Europe within 45 ...

The introduction of mandatory CE marking for batteries in August 2024 marked a major shift for manufacturing industries. This ...

Given the amount of tests that have required certification under the new system, the EU has staggered the grace periods for different classes of devices already holding CE-IVD marks obtained under the ...

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 ...

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.

SAN FRANCISCO, Oct. 23, 2025 /PRNewswire/ -- Alife Health, a health tech company advancing the future of fertility care with artificial intelligence, today announced that Embryo Predict™, its ...

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 ...

In another boost to its diabetes portfolio, Medtronic plc was granted CE mark approval for its Simplera continuous glucose monitor (CGM) sensor. The EU greenlight for Simplera follows the U.S. FDA ...

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.