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Tempus Receives U.S. FDA 510(k) Clearance For Tempus ECG-AF, An AI-based Algorithm That Identifies Patients At Increased Risk Of Atrial Fibrillation/ Flutter

Author: Benzinga Newsdesk | June 26, 2024 09:31am

Tempus AI, Inc. (NASDAQ:TEM), a leader in artificial intelligence and precision medicine, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Tempus ECG-AF device that uses AI to help identify patients who may be at increased risk of atrial fibrillation/flutter (AF). This is the first FDA clearance for an AF indication in the category known as "cardiovascular machine learning-based notification software" and paves the way for physicians to use this innovative algorithm in the care of their patients.

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