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 ...

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 ...

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 ...

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 ...

Beam Global announced that its products, including EV ARC™, BeamBike™, BeamWell™, and BeamPatrol™, have received the CE mark, which signifies compliance with European Union health, safety, and ...

Convatec Group plc secured CE mark and UKCA approvals for Convamatrix, its porcine placenta-based wound dressing designed for hard-to-heal wounds. The single use, skin substitute product is intended ...