(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 ...

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 ...

GenesisX was approved in Europe and is set to be approved in the US late this year. The new robot is a giant leap forward in accessibility. Stereotaxis should get MAGiC approved in Europe in October.

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.