Tempus AI Secures FDA Clearance for ECG Software, Targeting Pulmonary Hypertension

Tempus AI, Inc. received FDA 510(k) clearance for its AI-enabled software, Tempus ECG-PH. The device analyzes standard 12-lead electrocardiograms to detect signs of pulmonary hypertension.

Pulmonary hypertension is difficult to diagnose early due to non-specific symptoms and invasive testing requirements. The software is intended for use in symptomatic patients aged 40 and older.

This clearance marks the third FDA-cleared cardiovascular device in the company's portfolio. Tempus AI aims to identify at-risk patients earlier to improve clinical outcomes.