To avoid overlaps, the industry is calling for aligning MDR/IVDR with the EU's digital frameworks, pharmaceutical regulations ...

The Medical Device Regulation (EU) 2017/745 replaces the previous Medical Device Directive (MDD), introducing stricter requirements for clinical evidence, post-market surveillance, and ...

Paragonix Technologies, a pioneer in organ transplant technologies and organ procurement services, announced today that five of its devices have now received approval under the European Union (EU) ...

The medical device industry landscape is evolving rapidly, driven both by regulatory changes and the quest for innovation. The new European Medical Device Regulation (EU MDR) and its ...

The DMA, or Digital Markets Act, is an antitrust law that passed in 2022. It’s designed to regulate large tech firms that ...

The European Union has sent Apple preliminary instructions on how it expects the iPhone maker to comply with interoperability ...

WALTHAM, Mass., March 13, 2025--(BUSINESS WIRE)--Paragonix Technologies, a pioneer in organ transplant technologies and organ procurement services, announced today that five of its devices have ...

Paragonix Technologies, a pioneer in organ transplant technologies and organ procurement services, announced today that five of its devices have now received approval under the European Union (EU ...