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

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

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

The City of Ames is planning to add "personal transportation devices" to its code and add more micromobility regulations.

FDA is removing barriers to real-world evidence in device applications, allowing the use of de-identified patient data from ...

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

Regulatory overhaul aims to cut compliance burdens, improve safety, and attract investment in India’s $15B medical devices ...

The FDA recently had a meeting to explore regulatory aspects of AI-enabled mental health medical devices. I explore a useful ...

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

The Centre plans a major overhaul of India’s medical device regulatory framework by removing expiry-based licences and introducing perpetual approvals, along with standardised laboratory testing norms ...

A Parliamentary Panel urges digitised, time-bound CDSCO approvals, AI tools, single-query systems and conditional ...