India, Aug. 25 -- Tempus AI Inc. (TEM), a healthcare technology company, on Monday announced a 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Tempus PH-ECG, an AI-enabled software capable of diagnosing pulmonary hypertension (PH) by analyzing electrocardiograms (ECGs).
Pulmonary hypertension is defined by the stiffening and narrowing of blood vessels in the lungs, resulting in a strain on the right side of the heart. The disorder affects about 10% of people above 65 years of age, but diagnosis involves right heart catheterization and echocardiography.
The company designed the Tempus PH-ECG software to analyze resting, non-ambulatory, 12-lead echocardiogram recordings to identify elevated mean arterial pressure (over...