But this time, the unknown is hitting the industry in a different way from when Prasad was tapped to lead CBER less than ...

There’s no questioning that AI should have governance and guardrails. As much good as it can bring, it also heightens risk.

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...

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

The FDA’s regular communications based on reports from its drug safety report database don’t always rattle investors’ cages. But that was not the case with a regulatory update Monday on ...

FDA stops Olympus devices from entering the US The agency said it issued the import alerts because it “continues to have concerns related to outstanding Quality System regulation violations by ...

As the market for AI enabled medical devices grows, experts say there is less transparency around device approvals.

FDA Will Use AI to Approve Drugs and Devices Faster The agency launched a large-language model, dubbed Elsa, just last week to streamline operations.

How can medtech manufacturers minimize the risk of regulatory delays? Medical device manufacturers should be proactive in preparing filings by ensuring systems are designed to achieve their intended ...

Clinical-stage company earns key regulatory milestone as it advances a first-of-its-kind heart replacement system toward wider use. HUNTINGTON BEACH, Calif.-- (BUSINESS WIRE)-- #BiVACOR --BiVACOR, a ...