Tempus AI Receives FDA Clearance for ECG-MR Tool to Identify Moderate or Severe Mitral Regurgitation

09:10 AM EDT, 09/28/2026 (MT Newswires) -- Tempus AI (TEM) said Monday that it has secured a 510(k) clearance from the US Food and Drug Administration for its Tempus ECG-MR, an artificial intelligence-powered product designed to identify moderate or severe mitral regurgitation. Tempus ECG-MR supports early detection of high-risk patients who should be referred for further evaluation, the company said. Shares of the company were down 1.2% in Monday's premarket activity.