Proposals include establishing "indirect recognition" of EU CE-marked devices to the UK market and "international reliance" ...

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is getting better, and use is not mandatory.

The U.S. Medical Device 3PL market is set for growth, driven by the complexity of modern devices needing specialized ...

As medical technology evolves, advanced packaging must meet rising demands for safety, sustainability, and efficiency in healthcare.

The FDA is still on track to meet its user fee targets despite a higher-than-normal vacancy rate among scientific reviewers.

Artificial intelligence (AI) is already indispensable in the healthcare and life sciences sector. Intelligent medical devices promise nothing ...

The Advanced Medical Technology Association (AdvaMed) has expressed support for the Trump administration’s artificial intelligence (AI) action plan.

The agency claims Whoop is marketing an unauthorized medical device intended to diagnose, cure, treat or prevent a disease.

Stoned AI delivers hallucinations and headaches The Trump administration is flogging artificial intelligence as the silver ...

The milestone reinforces the company as the new benchmark for safe, trusted healthcare AI across Europe.<a href = ...

The MHRA has now published the government's response to its public consultation on future routes to market for medical ...