FDA Clears AI Product that Detects Pulmonary Hypertension from Standard ECGs

Aug. 24, 2026 — Tempus AI, Inc. 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 spectrum of cardiovascular disease. We’re building tools that can help clinicians surface risk earlier."

Tempus ECG-PH

Tempus ECG-PH is software intended to analyze resting, non-ambulatory 12-lead ECG recordings and detect signs associated with a patient having elevated mean pulmonary artery pressure (mPAP > 20 mmHg), an indicator of pulmonary hypertension (PH). It is for use on clinical diagnostic 12-lead ECG recordings collected at a healthcare facility from patients 40 years of age or older with cardiovascular symptoms (dyspnea, fatigue, chest pain, or edema), who do not have a known history of PH.

Tempus ECG-PH only analyzes ECG data and provides a binary output for interpretation. Tempus ECG-PH is not intended to be a stand-alone diagnostic tool for PH, should not be used for serial patient monitoring, and should not be used on ECGs with paced rhythms. Results should always be interpreted in conjunction with other diagnostic information, including the patient’s original ECG recordings, as well as the patient’s symptoms, other tests, and clinical history.

1. Hoeper MM, Humbert M, Souza R, et al. A global view of pulmonary hypertension. The Lancet Respiratory Medicine 2016;4(4):306-322.