Chicago, Illinois, USA, Aug 26, 2026
Tempus AI, Inc. has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Tempus ECG-PH, an AI-enabled software medical device designed to analyze standard 12-lead electrocardiograms (ECGs) for signs associated with pulmonary hypertension (PH). The clearance, announced on August 24, 2026, in Chicago, Illinois, expands Tempus’ cardiovascular technology portfolio and marks its third FDA-cleared cardiovascular device. Tempus ECG-PH is intended to analyze resting, non-ambulatory 12-lead ECG recordings collected at healthcare facilities from patients 40 years of age and older who have cardiovascular symptoms, including dyspnea, fatigue, chest pain or edema, but no known history of pulmonary hypertension. The software provides a binary output indicating whether the ECG shows signs associated with elevated mean pulmonary artery pressure above 20 mmHg, an indicator of PH. By applying artificial intelligence to routinely collected ECG data, the technology is designed to help clinicians identify patients who may warrant further evaluation for a condition that can otherwise be difficult to recognize early.
AI Technology Targets an Underdiagnosed Heart Condition
Pulmonary hypertension is characterized by stiffening and narrowing of blood vessels in the lungs, placing additional strain on the right side of the heart. According to Tempus, the condition affects approximately 1% of the population and as many as 10% of adults over 65. Diagnosis can be challenging because symptoms may be nonspecific, while conventional diagnostic pathways can require advanced testing. Right heart catheterization, considered an invasive diagnostic procedure, and echocardiography are commonly used in the evaluation of pulmonary hypertension. Tempus’ new ECG-PH technology is positioned as an additional AI-supported tool that could help surface signs associated with the disease from a standard ECG performed during routine clinical care. Brandon Fornwalt, MD, PhD, Senior Vice President of Cardiology at Tempus, said the company aims to use AI to help identify patients across the cardiovascular disease spectrum and potentially support earlier recognition. The technology is therefore focused on risk identification rather than replacing established diagnostic evaluation, with clinicians expected to interpret results alongside the original ECG, symptoms, medical history and other diagnostic information.
Tempus Expands Its FDA-Cleared Cardiovascular Portfolio
The FDA clearance further strengthens Tempus’ growing cardiovascular AI portfolio, following its previously cleared products for atrial fibrillation and low ejection fraction. Tempus ECG-PH is specifically designed for patients with cardiovascular symptoms who do not have a known history of PH, and it is not intended as a standalone diagnostic tool. The software should not be used for serial patient monitoring or with ECGs showing paced rhythms. These limitations emphasize the role of the technology as a clinical decision-support tool within a broader diagnostic workflow. Tempus describes its broader strategy as applying artificial intelligence, multimodal healthcare data and precision medicine technologies to support clinicians and therapeutic development. The company has developed a large-scale data and computing infrastructure intended to connect clinical information with AI-enabled solutions. With ECG-PH, Tempus is extending this approach into another area of cardiovascular medicine where earlier identification could potentially support additional clinical assessment. The newly cleared product represents a further step in the integration of AI and cardiovascular diagnostics, although its real-world clinical impact will depend on how clinicians incorporate the technology into patient evaluation and follow-up.
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Source: Tempus AI press relese
