This authorisation will expand the B-Right AI platform’s use to Europe, as BrightHeart continues to roll the technology out ...

This article will examine market access outside the EU/EEA based on reliance and recognition. For countries outside the European Union (EU) and European Economic Area (EEA), regulatory reliance and ...

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 ...

Company focusing resources on near-term commercial milestones; European CE Mark process and Healthcare Research revenue opportunities Process intended to evaluate strategic growth alternatives to ...

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 ...

The European Commission issued new rules on 24 September 2013 that establish a new EU process for designating and monitoring Notified Bodies, establishing the basis for withdrawing such a designation ...