India, Sept. 28 -- Tempus AI, Inc. (TEM) announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Tempus ECG-MR, an artificial intelligence (AI) product designed to analyze standard 12-lead resting electrocardiograms (ECGs) for signs associated with undiagnosed moderate or severe mitral regurgitation (MR).
MR is a common heart valve condition in which blood leaks backward through the mitral valve. Early-stage MR may be asymptomatic or present with non-specific symptoms, potentially resulting in delayed diagnosis.
Tempus ECG-MR is intended to help identify patients at higher risk of moderate or severe MR who may require further evaluation, including diagnostic imaging.
The software analyzes resting,...