Drug Eluting Stents are anticipated to lead the product category, holding 34.5% of the market revenue in 2025. Their clinical demand stems from their ability to prevent restenosis and maintain ...

Infuse for TLIF initially received FDA breakthrough device designation in April 2024. A new indication could expand treatment ...

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" ...

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 ...

Here’s what food and drug regulation might look like under the Trump administration Leaders of the FDA have published a list of new priorities for the agency.

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.

BiVACOR, a clinical-stage medical device company developing the world’s first titanium Total Artificial Heart (TAH), today announced that its device has rece ...

His background is in medicine, suggesting expertise with respect to drug and medical device regulation, rather than food safety specifically.