CE mark awarded for aXess™ at record speed, underpinned by strong EU pivotal trial data Xeltis advances ahead of schedule to ...
(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 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 ...
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 ...
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 ...
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