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# Tempus AI Device for Atrial Fibrillation
- URL: https://www.fdaweb.com/tempus-ai-device-for-atrial-fibrillation/
- Published: 2024-06-26T12:00:00.000Z
- Updated: 2026-09-14T14:34:14.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157254

FDA has cleared a Tempus AI 510(k) for its Tempus ECG-AF device that uses artificial intelligence to help identify patients at increased risk of atrial fibrillation/flutter (AF). The company says this is the first FDA clearance for an AF indication in the category known as “cardiovascular machine learning-based notification software.”

AF affects millions of people and can be challenging to diagnose, according to the company. “We believe that there are too many patients who die from AF-related causes unnecessarily due to underdiagnosis or undertreatment,” it says.

The device’s algorithm analyzes recordings of 12-lead electrocardiogram (ECG) devices and detects signals associated with a patient experiencing AF within the next 12 months, Tempus says. It is for use on resting 12-lead ECG recordings collected at a healthcare facility from patients 65 years of age or older who do not have a known history of AF or other specified conditions, (XXX DELETE LAST SENTENCE XXX)it says.