Tempus AI wins FDA clearance for ECG-MR tool to flag undiagnosed mitral regurgitation

• Tempus AI received FDA 510(k) clearance for ECG-MR, an AI tool that flags signs linked to undiagnosed moderate or severe mitral regurgitation.
• The software analyzes standard resting 12-lead ECGs to identify high-risk patients for follow-up evaluation such as diagnostic imaging.
• The clearance expands its ECG-AI portfolio to four FDA-cleared products spanning arrhythmia, heart function, pulmonary vascular, and valvular disease.

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