Tempus AI, Inc. (NASDAQ: TEM) has received 510(k) clearance from the U.S. Food and Drug Administration for Tempus ECG-PH, an AI-enabled software device that analyzes standard 12-lead electrocardiograms for signs associated with pulmonary hypertension.

The clearance marks the third FDA-cleared cardiovascular device in Tempus' portfolio, joining previously cleared products for atrial fibrillation and low ejection fraction.

Tempus ECG-PH is designed to detect signs associated with elevated mean pulmonary artery pressure above 20 mmHg. It is intended for use on ECG recordings collected at healthcare facilities from patients 40 years of age or older who present with cardiovascular symptoms such as dyspnea, fatigue, chest pain, or edema, and who do not have a known history of pulmonary hypertension.

Pulmonary hypertension affects roughly 1% of the general population and up to 10% of adults over 65, according to a 2016 study published in The Lancet Respiratory Medicine. Diagnosis typically requires right heart catheterization and echocardiography.

The device provides a binary output and is not intended as a stand-alone diagnostic tool. It should not be used for serial patient monitoring or on ECGs with paced rhythms, and results must be interpreted alongside other clinical information.

"Pulmonary hypertension has historically been underdiagnosed because early symptoms are non-specific and gold-standard diagnostics are invasive," said Brandon Fornwalt, MD, PhD, Senior Vice President of Cardiology at Tempus.

The information in this article is based on a press release issued by Tempus AI.