Tempus AI said on Monday it received 510(k) clearance from the U.S. Food and Drug Administration for Tempus ECG-PH, an AI-enabled software designed to analyze standard 12-lead electrocardiograms for signs associated with pulmonary hypertension.
The tool is intended for patients aged 40 or older presenting cardiovascular symptoms such as shortness of breath, fatigue, chest pain or swelling, but with no prior diagnosis of pulmonary hypertension. It flags cases where elevated mean pulmonary artery pressure exceeds 20 mmHg, a threshold linked to the condition.
This marks Tempus’ third cardiovascular clearance from the FDA, following prior approvals for tools detecting atrial fibrillation and low ejection fraction. Brandon Fornwalt, Tempus’ Senior Vice President of Cardiology, noted that pulmonary hypertension remains underdiagnosed due to nonspecific early symptoms and the invasive nature of standard diagnostic procedures such as right heart catheterization.
Tempus ECG-PH is not designed as a standalone diagnostic; its binary output must be interpreted alongside clinical data and patient history. The company specified that the software should not be used for serial monitoring or on ECGs with paced rhythms.
Pulmonary hypertension affects roughly 1% of the general population and up to 10% of adults over 65, according to medical estimates. The condition is typically confirmed through invasive procedures, though echocardiography is also used in initial assessments.
