Tempus AI (TEM) Stock Gains FDA Clearance for Pulmonary Hypertension AI Tool
TLDR
- Tempus AI received FDA 510(k) clearance for its ECG-PH software, which uses AI to detect signs of pulmonary hypertension from standard 12-lead ECGs.
- This is Tempusโ third FDA-cleared cardiovascular AI product, joining tools for atrial fibrillation and low ejection fraction.
- Pulmonary hypertension affects roughly 1% of the population and up to 10% of adults over 65.
- The device is not a standalone diagnostic tool and must be used alongside other clinical information.
- The software only works on patients aged 40 or older who have cardiovascular symptoms and no prior PH diagnosis.
Tempus AI (TEM) has received FDA 510(k) clearance for Tempus ECG-PH, an AI-powered software tool designed to detect signs of pulmonary hypertension using standard 12-lead electrocardiograms.
The clearance marks the third FDA-approved cardiovascular AI product in Tempusโ portfolio. The company already holds clearances for tools targeting atrial fibrillation and low ejection fraction.
Pulmonary hypertension is caused by stiffening and narrowing of the blood vessels in the lungs, which puts pressure on the right side of the heart. It affects around 1% of the general population and up to 10% of adults over 65.
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