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

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 ...

The former official, Vinay Prasad, had been on the job three months and had recently come under attack by conservative ...

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

In a breakthrough for cardiovascular medicine, researchers have harnessed artificial intelligence to discover unexpected ...

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

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

Chicago-based Cardiosense has received 510(k) clearance from the FDA for its CardioTag device, a multimodal wearable sensor.  The CardioTag is designed to provide clinicians with a comprehensive, ...

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

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

Medical device lobbyists and lawmakers have united in recent months over legislation that would make it easier to bill ...