Tempus AI Gets 510(k) Clearance for ECG-AF Device

By Chris Wack

Tempus AI said it received 510(k) clearance from the U.S. Food and Drug Administration for its Tempus ECG-AF device, which uses artificial intelligence to help identify patients who may be at increased risk of atrial fibrillation/flutter.

The medicine company said this is the first FDA clearance for an AF indication in the category known as "cardiovascular machine learning-based notification software."

Tempus said this device will offer physicians AI-based clinical technology to support the potential for earlier identification of cardiovascular disease and conditions.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

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