Tempus AI receives 510(k) clearance for Tempus ECG-AF

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