Tempus AI receives FDA 510(k) clearance for its ECG-MR AI product
The product analyzes standard 12-lead resting electrocardiograms to detect signs of undiagnosed moderate or severe mitral regurgitation.
GetSignal Tempus AI Inc TEM
Tempus AI said on September 28, 2026 that the U.S. Food and Drug Administration has cleared its Tempus ECG-MR product through a 510(k) clearance.
Mitral regurgitation is a common form of heart valve disease in which blood leaks backward through the mitral valve.
Key facts
- Clearance
- 510(k), U.S. Food and Drug Administration
- Product
- Tempus ECG-MR
- Condition targeted
- Undiagnosed moderate or severe mitral regurgitation
Source: The company's release on Business Wire, September 28, 2026.
Written by GetSignal with AI from the company's press release.
Not investment advice.
