Tempus AI Receives 510(k) Clearance From FDA For Tempus ECG-MR, AI Product That Analyzes Standard 12-Lead Resting Ecgs To Detect Signs Associated With Undiagnosed Mitral Regurgitation

ECG-MR becomes the fourth FDA-cleared Tempus ECG-AI product, spanning arrhythmia, heart function, pulmonary vascular and valvular disease

Tempus AI, Inc. (NASDAQ:TEM) today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Tempus ECG-MR, an AI product that analyzes standard 12-lead resting electrocardiograms (ECGs) to detect signs associated with undiagnosed moderate or severe mitral regurgitation (MR).

MR is a common form of heart valve disease where blood leaks backward through the mitral valve. Because early stages are often asymptomatic or manifest as non-specific symptoms like shortness of breath, MR frequently remains undiagnosed until advanced stages. Tempus ECG-MR serves as an early detection tool to help identify high-risk patients who should be referred for further evaluation, such as follow-up diagnostic imaging.