Tempus AI wins FDA clearance for ECG-MR tool to flag undiagnosed mitral regurgitation
TEM•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, and expands the company’s ECG-AI portfolio to four FDA-cleared products.
1. FDA clearance
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.
2. Expanded portfolio
The clearance brings Tempus AI’s ECG-AI portfolio to four FDA-cleared products spanning arrhythmia, heart function, pulmonary vascular and valvular disease.
