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 ...

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

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 ...

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

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

Earlier this year, the FDA unveiled Elsa, an artificial intelligence tool that's expected to speed up the process for ...

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

The wearable, noninvasive CardioTag is designed to capture electrocardiogram, photoplethysmogram, and seismocardiogram signals, as well as heart rate and pulse rate.

Cardiosense announced today that it received FDA 510 (k) clearance for its CardioTag wearable sensor device.