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

Science evolves as both controlled clinical research and real-world evidence show us how to use health care technologies to ...

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 ...

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

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.

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

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

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

Ultromics announced that it raised $55 million in a Series C financing to support its AI-powered heart failure diagnostic ...

The FDA's generative AI, Elsa, has a massive hallucination problem, according to the agency's employees themselves.