A new FDA artificial intelligence tool designed to streamline medical device reviews is faltering in its early rollout stages, raising concerns for agency staff and ethics experts about its ...

FDA Commissioner Dr. Martin A. Makary said the agency is taking aggressive steps to modernize outdated regulations, expand ...

Musk has previously stated that humans may be able to surf the web with their thoughts by the end of 2030, Reuters reported. The claim has drawn renewed attention amid the funding news. In January, ...

There is a nearly five-year gap between when a new medical device receives FDA approval and is subsequently covered by ...

The Trump Administration has effectively ended the Biden Administration's attempt to regulate lab-developed tests,” TD Cowen ...

Brain-computer interface technology shows promise in helping motor-impaired patients, like those with Lou Gehrig's disease, ...

As noted in our earlier alert, the FDA continues to face mounting internal pressure, ranging from staffing reductions and ...

However, the integration of AI into medical devices raises significant regulatory challenges. Ensuring that these ...

The approval is based on a trial that revealed that the system’s treatment led to improvements in disability and pain.

The FDA compiled the list using product codes and device summaries. The list is not exhaustive ... The EPA is expected to finalize new regulations in March that would limit ethylene oxide emissions ...

On 16 May 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance for medical device manufacturers on the changed requirements for post-market surveillance (PMS) ...