10:31 AM EDT, 06/26/2024 (MT Newswires) -- Tempus AI ( TEM ) said Wednesday that its Tempus ECG-AF device, to identify patients with increased risk of atrial fibrillation or flutter, has received the US Food and Drug Administration's 510(k) clearance.
The company said the device uses artificial intelligence to identify patients at risk for different heart disease conditions and got clearance under the category of "cardiovascular machine learning-based notification software."
Tempus ECG-AF algorithm works with 12-lead electrocardiogram devices and can detect signs related to patients experiencing atrial fibrillation in the next 12 months, according to Tempus.
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