Tempus Receives FDA Clearance for its AI Product Intended to Detect Signs of Pulmonary Hypertension From Standard ECGs
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ECG-PH clearance adds pulmonary hypertension to Tempus' FDA-cleared AI products for atrial fibrillation and low ejection fraction CHICAGO, August 24, 2026 --( 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 company's suite of next-generation AI products aimed at identifying patients at risk for complex cardiac conditions. PH is characterized by stiffening and narrowing of the blood vessels in the lungs, putting strain on the right side of the heart. It affects roughly 1% of the population and up to 10% of adults over 651, yet can be difficult to diagnose. PH diagnosis typically requires right heart catheterization, an invasive procedure, and echocardiography. "Pulmonary hypertension has historically been underdiagnosed because early symptoms are non-specific and gold-standard diagnostics are invasive," said Brandon Fornwalt, MD, PhD, Senior Vice President of Cardiology at Tempus. "This third FDA-cleared cardiovascular device reflects our broader goal of using AI to help identify patients across the...
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