Medical technology company Tempus AI Inc (NASDAQ: TEM) reported on Monday 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 analyse standard 12-lead electrocardiograms (ECGs) for signs associated with pulmonary hypertension.

The clearance expands Tempus' cardiovascular portfolio to three FDA-cleared AI products, including those for atrial fibrillation and low ejection fraction.

Tempus ECG-PH analyses resting ECG recordings to detect signs associated with elevated mean pulmonary artery pressure, an indicator of pulmonary hypertension. It is intended for patients aged 40 and over with cardiovascular symptoms who have no known history of the condition.

The software provides a binary output and is not intended as a standalone diagnostic tool or for serial monitoring. Results are intended to be interpreted alongside the patient's ECG, symptoms, clinical history and other diagnostic information.