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 ...

CMR Surgical announced today that it received CE mark and UK approval for its Versius surgical robot in pediatric surgery.

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.

(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 ...

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 ...

VANCOUVER, BC / ACCESSWIRE / September 27, 2023 / EvokAI Creative Labs Inc. (TSXV:OKAI)(OTCQB:OKAIF) ("EvokAI" or the "Company"), a leading MedTech AI-powered company dedicated to the development of ...

Stereotaxis' MAGiC catheter received CE Mark approval in Europe, enabling the company to earn an additional $3k per procedure with +80% gross margins. FDA approval of MAGiC is expected by September.