The question is not whether AI will transform healthcare; it’s whether regulators can keep pace with that transformation.

The rise of AI in health care presents new challenges related to the patentability and regulation of AI-driven medical ...

Precision Neuroscience has received FDA approval for a key component of its brain-computer interface, aimed at restoring ...

One attorney said the ruling “isn’t quite the stake in the heart.” The FDA is unlikely to challenge the court’s decision, but ...

The US FDA is coping with a series of Trump-imposed job cuts. These are starting to hamper food safety and pharmaceutical ...

On Monday, March 31, a court in the Eastern District of Texas found unlawful and vacated the Food and Drug Administration’s ...

In another rebuke to federal regulatory overreach, the U.S. District Court for the Eastern District of Texas (“District Court”) has vacated the ...

The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, ...

HHS Secretary Robert F. Kennedy Jr.’s sweeping layoffs across federal health agencies are disrupting the work of drug, ...

The legislation would allow the FDA to approve drugs and devices that have already been approved in other industrialized ...

After mass layoffs, the FDA has started missing certain deadlines, pushing one biopharma to delay a phase 3 trial and ...

Precision Neuroscience announced today that it received FDA 510(k) clearance for its Layer 7 cortical interface for BCI ...