An ongoing tug-of-war between federal and state governments exacerbates the need for continually updating AI governance ...

The agency will conduct a controlled experiment on a closed course to study the effects of warning devices to help determine ...

EPA proposes some stricter PFAS rules for medical device makers, cutting reporting timeline from 6 to 3 months as companies ...

This week in Pedersen's POV, our senior editor finds humor in the European Commmission's plan to simplify the EU Medical ...

Restrictions on ‘medical devices’ currently prevent us from unlocking some capabilities.

If finalized, the changes would reduce the scope of AI regulations for medical devices and include more provisions for rare ...

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a call for evidence on artificial intelligence ...

numares Health enters ASEAN region with regulatory approval in Malaysia and first contract win for AXINON (R) LDLp Test System -- AXINON (R) LDLp Test System receives Medical Device Authority (MDA) in ...

Following the identification of several key challenges in the application of the Medical Device Regulation (MDR) and In Vitro ...

Since the 2017 publication of the medical device regulation (MDR) and the IVD regulation (IVDR), EU regulations for medical ...