Tempus gains FDA clearance for mitral-regurgitation screening AI

Tempus AI ($TEM) has received FDA 510(k) clearance for ECG-MR, software that examines standard resting 12-lead electrocardiograms for signs associated with previously undiagnosed moderate or severe mitral regurgitation. It is the company’s fourth cleared ECG-AI product. The intended population is patients aged 65 or older with cardiovascular risk factors, without a prior mitral-valve intervention or an existing diagnosis of moderate or severe disease.

The clearance expands Tempus’s cardiology portfolio and could help clinicians identify patients needing confirmatory imaging using a test already common in care. Its scope is nevertheless limited: ECG-MR is not a standalone diagnostic tool, is not for serial monitoring, and should not analyze paced rhythms. Results must be assessed alongside other clinical information. No sales forecast or reimbursement terms accompanied the announcement.

Sources:

• Tempus company release — Business Wire / StockTitan