As the threat of counterfeiting continues to torment industry stakeholders and patients, more strategic approaches to ...

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 getting better, and use is not mandatory.

Despite campaign-trail promises from Donald Trump to protect flavored vapor products, tobacco harm reduction tools remain ...

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

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

Health system leaders are monitoring AI regulation as states and the federal government take different approaches to the technology. The One Big Beautiful Act originally included a 10-year ban on ...

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

The Food and Drug Administration (FDA) can maintain its high bar for safety and efficacy, and also cut the waste and unnecessary delays in the regulatory process.

The FDA has barred the import of multiple medical devices manufactured by Olympus Medical Systems and its subsidiaries in Japan, citing ongoing violations of federal quality system regulations ...

AI-enabled medical devices often fall under multiple regulatory frameworks, which can create conflicts: • The FDA regulates AI as a medical device under its Digital Health Software ...

According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device clearances. That includes the Jan. 17 green light of Myocene’s ...