Huma Therapeutics Ltd. received the first EU Class IIb approval for a software as a medical device (SaMD) product, winning the certification for its system for collecting and analysing patient data ...

The European Commission’s Medical Device Coordinating Group (MDCG) has revised several documents addressing the classification of products under the Medical Device Regulation (MDR) and the In Vitro ...

Infermedica earns EU MDR Class IIb certification, validating its AI platform’s safety, clinical rigor, and regulatory compliance. With this certification, we’re proud to demonstrate that our solutions ...