Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 FDA Clears Tempus AI Tool to Flag Pulmonary Hypertension

What are you searching for?

Sign in
OEM News

FDA Clears Tempus AI Tool to Flag Pulmonary Hypertension

Tempus ECG-PH analyzes resting 12-lead ECGs from patients 40 and older with cardiovascular symptoms to detect signs of elevated mean pulmonary artery pressure.

Author Image

By: Sam Brusco

Associate Editor

Tempus AI has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Tempus ECG-PH (pulmonary hypertension), AI-enabled software that analyzes 12-lead ECGs for signs related to PH.

Pulmonary hypertension (PH) narrows and stiffens lung blood vessels, straining the right side of the heart. It affects about 1% of the population and up to 10% of adults over 65, but diagnosis can be challenging and often requires invasive right heart catheterization and echocardiography.

Tempus ECG-PH analyzes resting 12-lead ECGs from patients 40 and older with cardiovascular symptoms to detect signs associated with elevated mean pulmonary artery pressure, an indicator of pulmonary hypertension.

The software provides a binary result and is intended to support, not replace, clinical assessment. It is not a standalone diagnostic or monitoring tool and should not be used with paced rhythms; results should be interpreted alongside the patient’s ECG, symptoms, clinical history, and other diagnostic findings.

Tempus ECG-PH is the third FDA-cleared device in Tempus’ cardiovascular portfolio, expanding its AI-powered tools for identifying patients at risk of complex cardiac conditions.

“Pulmonary hypertension has historically been underdiagnosed because early symptoms are non-specific and gold-standard diagnostics are invasive,” said Brandon Fornwalt, MD, Ph.D., senior VP 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.”

Add us as a preferred source on Google

Get the latest Medical Product Outsourcing news, insights and analysis in your Google Search and AI experiences.

Add Medical Product Outsourcing as a preferred source on Google (opens in a new tab)

Keep Up With Our Content. Subscribe To Medical Product Outsourcing Newsletters

Topics