Tempus AI wins FDA 510(k) clearance for ECG-PH pulmonary hypertension software

AllThingsApx · x · 2026-08-25

Tempus AI received FDA 510(k) clearance for Tempus ECG-PH, an AI-enabled software that analyzes standard 12-lead ECGs for signs of pulmonary hypertension. This is the third FDA-cleared device in their cardiovascular portfolio, expanding their suite of next-gen AI products for identifying patients at risk of complex cardiac conditions.

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