The FDA has cleared Tempus ECG-PH, software from Tempus AI that reviews routine resting 12-lead electrocardiograms for hints of elevated mean pulmonary artery pressure. Elevated readings point to pulmonary hypertension, a condition that is easy to miss.
The Chicago company said the clearance is its third for a cardiovascular AI product, following devices for atrial fibrillation and low ejection fraction. Pulmonary hypertension affects about 1% of the population and up to 10% of adults over 65, yet it is frequently missed because early symptoms are vague and the gold-standard test, right heart catheterization, is invasive.
ECG-PH targets patients aged 40 and older with cardiovascular symptoms such as shortness of breath, fatigue, chest pain or edema who have no known history of the condition. The software returns a binary result and is not intended as a stand-alone diagnosis or for serial monitoring, and it should not be applied to paced rhythms.
Tempus cardiology chief Brandon Fornwalt argues the condition has long gone undetected because its early symptoms are generic while the definitive test is invasive. He says the new software exists to surface risk earlier, before the disease takes hold.
The clearance adds to a busy stretch for Tempus, which also earned FDA clearance this month for its PRISM2 pathology model. The company sees ECG analysis as a low-cost screen that could route more patients to confirmatory imaging and catheterization before the disease advances.
