Tempus AI gets FDA clearance for ECG-based AI pulmonary hypertension tool
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Tempus Receives FDA Clearance for its AI Product Intended to Detect Signs of Pulmonary Hypertension From Standard ECGs
August 24, 2026 8:30 AM EDTECG-PH clearance adds pulmonary hypertension to Tempus FDA-cleared AI products for atrial fibrillation and low ejection fraction
CHICAGO--(BUSINESS WIRE)-- Tempus AI, Inc. (NASDAQ: TEM) today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Tempus ECG-PH (pulmonary hypertension), an AI-enabled software device that analyzes standard 12-lead electrocardiograms (ECGs) for signs associated with pulmonary hypertension. Tempus ECG-PH is the third FDA-cleared device in Tempus growing cardiovascular portfolio, expanding the companys suite of next-generation AI products aimed at identifying patients at risk for... More
