FDA Clears Tempus AI Tool to Flag Pulmonary Hypertension

Tempus AI has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Tempus ECG-PH (pulmonary hypertension), AI-enabled software that analyzes 12-lead ECGs for signs related to PH.

Pulmonary hypertension (PH) narrows and stiffens lung blood vessels, straining the right side of the heart. It affects about 1% of the population and up to 10% of adults over 65, but diagnosis can be challenging and often requires invasive right heart catheterization and echocardiography.

Tempus ECG-PH analyzes resting 12-lead ECGs from patients 40 and older with cardiovascular symptoms to detect signs associated with elevated mean pulmonary artery pressure, an indicator of pulmonary hypertension.

The software provides a binary result and is intended to support, not replace, clinical assessment. It is not a standalone diagnostic or monitoring tool and should not be used with paced rhythms; results should be interpreted alongside the patient’s ECG, symptoms, clinical history, and other diagnostic findings.

Tempus ECG-PH is the third FDA-cleared device in Tempus’ cardiovascular portfolio, expanding its AI-powered tools for identifying patients at risk of complex cardiac conditions.

“Pulmonary hypertension has historically been underdiagnosed because early symptoms are non-specific and gold-standard diagnostics are invasive,” said Brandon Fornwalt, MD, Ph.D., senior VP 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.”