Tempus AI Secures FDA Clearance for Mitral Regurgitation Screening Tool

Tempus AI received U.S. Food and Drug Administration (FDA) clearance for ECG-MR AI, an algorithm that analyzes electrocardiograms (ECGs) to identify patients at high risk of undiagnosed mitral regurgitation, a common heart valve disorder.

The clearance allows Tempus AI to market the device in the United States. Cardiologists can use it as a non-invasive screening tool. The company said the technology could support earlier detection of the condition, which can lead to serious heart complications if left untreated.