Tempus ECG-MR gains FDA clearance for mitral-regurgitation signals
Source publication date
Site published
FDA decision K254297 is dated September 25. Eligible patients are 65 or older, have cardiovascular risk, and have neither previous mitral intervention nor diagnosed moderate/severe regurgitation. The manufacturer lists software version 2.1.0.
Summary
The U.S. company announced clearance for AI analysis of resting 12-lead ECGs.
Editorial view
Editorial view: existing ECG workflows can help identify candidates for further evaluation.
Evidence and limitations
510(k) clearance, not PMA approval. Not a standalone diagnosis, treatment trigger or serial monitor; paced rhythms are excluded. Hospital adoption and revenue are not established.