Tempus AI has announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) for Tempus ECG-PH (pulmonary hypertension), an artificial intelligence (AI)-enabled software device that analyses standard 12-lead electrocardiograms (ECGs) for signs associated with pulmonary hypertension.
Tempus ECG-PH is the third FDA-cleared device in Tempus’ cardiovascular portfolio, expanding the company’s suite of next-generation AI products aimed at identifying patients at risk for complex cardiac conditions.
PH is characterised by stiffening and narrowing of the blood vessels in the lungs, putting strain on the right side of the heart. PH diagnosis typically requires right heart catheterisation and echocardiography.
“Pulmonary hypertension has historically been underdiagnosed because early symptoms are non-specific and gold-standard diagnostics are invasive,” said Brandon Fornwalt, senior vice president of cardiology at Tempus. “This third FDA-cleared cardiovascular device reflects our broader goal of using AI to help identify patients across the spectrum of cardiovascular disease. We’re building tools that can help clinicians surface risk earlier.”
