Among 24 such systems (called devices in FDA parlance) authorized since 2015, FDA summaries for 14 lacked data on the ...

Insiders at the Food and Drug Administration are ringing alarm bells over the agency's use of an AI to fast-track drug ...

A new technology that harnesses artificial intelligence (AI) to analyze mammograms and improve the accuracy of predicting a ...

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

But three of those FDA employees told CNN that Elsa just makes up nonexistent studies, something commonly referred to in AI ...

Medical AI company Cardiosense has claimed an FDA clearance for its CardioTag device, a wearable sensor that provides a ...

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

FDA officials say the assistant is flawed, just as the Trump administration stresses AI adoption in healthcare.

At IAFP 2025, experts shared how AI and predictive modelling are now delivering tangible food safety outcomes across industry ...

With reports that FDA’s AI Elsa is “confidently hallucinating” studies that don’t exist, the use of AI to streamline drug ...

The federal agency introduced Elsa last month, boasting about the AI tool's ability to increase efficiency at the FDA.

Cardiosense has received U.S. Food & Drug Administration clearance for a wearable sensor that can measure multiple cardiac ...