Sources told CNBC -TV18 that government is in talks with the medical device industry to ensure that the Indian manufacturers ...

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

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

Enlil, Inc., a Shifamed Portfolio Company and leader in enabling MedTech product innovation, today announced seven new strategic partnerships formed to date in 2025. These agreements, spanning ...

The US Food and Drug Administration (FDA) has granted 510(k) clearance for CardioTag, Cardiosense’s multimodal, wearable sensor. Aimed at cardiac function monitoring, the device is said to capture ...

George Tidmarsh is taking on more responsibilities at FDA after the sudden departure of top official Vinay Prasad.

Whoop pushed back on the warning letter, claiming its blood pressure feature for a wearable wristband is for “wellness” and ...

Until the FDA streamlines and modernizes its regulatory process, states will continue stepping in, with inconsistent and ...

The FDA claims the wearable tech company's BPI offering is "adulterated" and "misbranded," and is being sold without the ...

Commissioner Marty Makary says the FDA will plow ahead with big plans on ultra process foods, dietary guidelines and ...

The U.S. Food and Drug Administration said on Tuesday it will now review all imports of the products it regulates regardless ...