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 ...

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

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

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

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.

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

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

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 ...

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, ...