(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 ...

GI Dynamics has lost the right to sell its Type 2 diabetes and obesity device in the European Union. SGS, the notified body for EndoBarrier, pulled the CE Certificate of Conformity over the weekend in ...

It serves as a critical gateway for market entry in these regions, ensuring the delivery of devices that uphold the highest ...

(2500.HK) today announced that Cardiovalve has submitted the CE technical file for its transcatheter tricuspid ...

HINGHAM, Mass., July 25, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), the developer of the LIBERTY ® Robotic Surgical System, the first single-use endovascular robotic system, today ...

While uncertainty remains about the terms and indeed the exact date by which the UK will leave the European Union, US companies that export electronic products to the EU and the UK marked with the "CE ...

Traditionally, if medical device manufacturers wanted to get products into a major market quick, they obtained CE Marking in the European Union first. The EU required proof of safety and performance, ...

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- CorMedix Inc. (“CorMedix”) (NYSE Amex: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and ...

New Delhi [India], October 24: Indian IVD manufacturers face growing regulatory hurdles under the EU IVDR. I3CGLOBAL provides strategic CE Marking support to small, medium, and large-scale ...