Tempus AI won FDA 510(k) clearance for Tempus ECG-PH, an AI tool that flags signs of pulmonary hypertension from standard 12-lead ECGs.
The software targets symptomatic patients aged 40 or older with no known pulmonary hypertension, supporting earlier risk identification in clinical settings.
It is the company’s third FDA-cleared cardiovascular device, expanding its regulated AI product portfolio.
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