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 ...

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 ...

In its letter to the European Commission, the European Organisation of Technical Assessment (EOTA) and stakeholders in the construction sector, the ERC advocates the adoption of CE marking through the ...

For manufacturers aiming to export electrical equipment to the European market, CE/UKCA Marking is a crucial requirement. CE Conformity Services provides the expertise and support needed to navigate ...

(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 ...

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 ...

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.

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 ...

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 ...

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 ...