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 ...

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 ...

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

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

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.

Despite ambitions to streamline regulatory review, FDA’s Elsa platform has been prone to hallucinations, prompting internal scrutiny and questions about AI reliability and governance.

Tempus AI (TEM) recently secured FDA clearance for its Tempus ECG-Low EF software and expanded its collaboration with Personalis for colorectal cancer detection, measures that collectively ...

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

The Food and Drug Administration's new AI tool, Elsa, is reportedly generating false studies, raising concerns about the ...