FDA Clears Tempus ECG-PH AI Software for Signs of Pulmonary Hypertension

Tempus AI has received U.S. Food and Drug Administration 510(k) clearance for Tempus ECG-PH, software that uses artificial intelligence to look for signs of pulmonary hypertension in standard 12-lead electrocardiograms. The FDA's 510(k) database lists the clearance as K253699, with a decision date of August 21, 2026, and the Chicago company announced it on August 24, according to Diagnostic and Interventional Cardiology.

The FDA classified the device as pulmonary hypertension machine learning-based notification software. The 510(k) was received on November 24, 2025, according to the database entry.

Who the software is for

Tempus ECG-PH analyzes resting, non-ambulatory 12-lead ECG recordings and detects signs associated with elevated mean pulmonary artery pressure, above 20 mmHg, which the company describes as an indicator of pulmonary hypertension. It is meant for clinical diagnostic ECGs collected at a health care facility from patients 40 or older who have cardiovascular symptoms, namely shortness of breath, fatigue, chest pain or swelling, and no known history of the condition.

The software analyzes ECG data only and gives a binary output. Tempus said it is not intended to be a stand-alone diagnostic tool for pulmonary hypertension, should not be used for serial patient monitoring and should not be used on ECGs with paced rhythms. Results are to be interpreted with other information, including the original ECG recordings, symptoms, other tests and clinical history, the company said.

Pulmonary hypertension involves stiffening and narrowing of blood vessels in the lungs, which strains the right side of the heart. Tempus said it affects roughly 1% of the population and up to 10% of adults over 65, and that diagnosis typically requires echocardiography and right heart catheterization, an invasive procedure.

"Pulmonary hypertension has historically been underdiagnosed because early symptoms are non-specific and gold-standard diagnostics are invasive," said Brandon Fornwalt, senior vice president of cardiology at Tempus.

A third cardiovascular clearance

ECG-PH is the third FDA-cleared device in Tempus' cardiovascular portfolio, following products for atrial fibrillation and low ejection fraction, the company said. Tempus described the products as part of a growing suite of AI tools aimed at identifying patients at risk for complex cardiac conditions; it also sells AI-enabled precision medicine products and maintains a large library of multimodal clinical data, Medical Economics reported. Medical Economics noted that the clearance adds to a growing number of AI tools designed to extract diagnostic signals from the electrocardiogram, an inexpensive, noninvasive test that is already part of routine care.

The announcement did not include the performance data submitted to the FDA, pricing or a commercial launch date. Medical Economics reported that wider use will depend on how health systems fold AI flags into referral pathways and on validation across diverse patient populations.