FDA Clears Tempus ECG-PH, Targeting PH That Affects 10% of Adults 65+

For cardiologists and health IT leaders, adding AI to ubiquitous 12-lead ECG data could expand detection of pulmonary hypertension without new hardware—addressing the underdiagnosis of a disease with nonspecific symptoms. This third cardiovascular clearance signals accelerating regulatory acceptance of machine learning as screening support in cardiac care.

Tempus AI, Inc. (NASDAQ: TEM) announced on August 24, 2026, that it has received 510(k) clearance from the U.S. Food and Drug Administration for Tempus ECG-PH, an AI-enabled software device designed to detect signs associated with pulmonary hypertension from standard 12-lead electrocardiograms. The company described the clearance as the third FDA-cleared device in its cardiovascular portfolio, an indication that Tempus is systematically building a suite of machine-learning tools for cardiac risk detection rather than pursuing one-off approvals. Because the announcement comes via press-release distribution rather than independent reporting, the clearance should be understood as a company-reported regulatory milestone.

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Pulmonary hypertension, characterized by stiffening and narrowing of pulmonary blood vessels that strains the right side of the heart, affects roughly 1% of the general population and up to 10% of adults over 65.

The clinical problem the product targets is significant. Pulmonary hypertension, characterized by stiffening and narrowing of pulmonary blood vessels that strains the right side of the heart, affects roughly 1% of the general population and up to 10% of adults over 65. Yet it remains difficult to diagnose because early symptoms such as dyspnea and fatigue are nonspecific, and gold-standard diagnosis often requires invasive right heart catheterization or echocardiography. By applying AI to the ubiquitous 12-lead ECG already collected in many care settings, Tempus is attempting to surface elevated risk earlier without adding new hardware or invasive procedures. The device analyzes resting, non-ambulatory 12-lead ECG recordings and returns a binary output indicating signs associated with elevated mean pulmonary artery pressure above 20 mmHg.

The intended-use population is narrowly defined: patients 40 years or older with cardiovascular symptoms such as dyspnea, fatigue, chest pain, or edema, and no known history of pulmonary hypertension. This constraint is important for regulatory strategy and clinical deployment. It limits the use case to a screening aid for symptomatic adults rather than a general population screener. Tempus explicitly states that ECG-PH is not intended as a standalone diagnostic tool; it only analyzes ECG data and provides an interpretation. This distinction matters for FDA's 510(k) pathway, which requires demonstration of substantial equivalence to a predicate device, and it positions the product as a clinician support tool rather than a replacement for catheterization or echocardiography. It may also help manage liability and reimbursement expectations.

From a portfolio perspective, the clearance reinforces Tempus's cardiovascular AI strategy. The company said it is now three FDA-cleared cardiovascular devices in, and Brandon Fornwalt, senior vice president of cardiology at Tempus, framed the approval as part of a broader goal to use AI to identify patients across the spectrum of cardiovascular disease. That sequencing suggests Tempus may be building an integrated cardiac AI platform that can analyze multiple sources of ECG and imaging data to flag different conditions. For health systems, that could mean a unified software stack deployed across existing ECG devices, reducing friction compared with point solutions.