Tempus AI Gets 510(k) Clearance for ECG-AF Device
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Dow Jones
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 chris.wack@wsj.com
(END) Dow Jones Newswires
June 26, 2024 10:06 ET (14:06 GMT)
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