Tempus AI Wins FDA 510(k) Clearance for ECG-Based Mitral Regurgitation Detection Software

Tempus AI, Inc. (TEM) said on September 28, 2026, that the U.S. Food and Drug Administration granted 510(k) clearance for Tempus ECG-MR, an artificial intelligence product that analyzes standard 12-lead resting electrocardiograms (ECGs) for signs associated with mitral regurgitation. The clearance allows Tempus to market the software as a screening aid for the heart valve condition, which is often underdiagnosed. The company did not disclose pricing or a commercial launch date. Tempus, which went public in 2024, builds AI-driven precision medicine tools spanning genomics and clinical data. Shares trade on the Nasdaq under the ticker TEM.