Study Backs Efficacy of Tempus AI’s Afib Risk Prediction Technology

Tempus AI Inc. is touting the multi-site validation of its U.S. Food and Drug Administration (FDA)-approved software that predicts the one-year risk of atrial fibrillation or flutter (AF).

Titled, “Multi-Center Validation of an Artificial Intelligence-Enabled ECG Model to Predict 1-Year Risk of Atrial Fibrillation or Flutter,” the study appeared in Heart Rhythm.

AF is the most prevalent cardiac arrhythmia and is associated with an increased risk of stroke, heart failure, and death. AF is frequently asymptomatic and paroxysmal, so it can be difficult to detect; however, the application of artificial intelligence (AI) to electrocardiogram (ECG) interpretation offers a promising avenue for improving diagnosis, according to the company.

The study evaluated the Tempus ECG-AF software¹ across three geographically distinct clinical sites. Trial administrators aggregated ECG data and manually reviewed patient charts to identify eligible patients—those ages 65 and older with no prior AF and no history of pacemaker or defibrillator use. Study endpoints were defined as a new AF diagnosis within one year or one year of AF-free follow-up. Among the 4,017 patients evaluated, the ECG-AI-derived risk score surpassed pre-specified performance thresholds, and the resulting data supported Tempus’ FDA clearance of the technology.

“This study marks an important step toward shifting cardiac care from late-stage intervention to early risk detection,” Tempus Senior Vice President of Cardiology and study co-author Brandon Fornwalt, M.D., Ph.D., stated. “The ability of our AI model to consistently predict atrial fibrillation across varied clinical environments highlights its potential as a dependable decision-support tool. We believe this will enable clinicians to surface hidden risks sooner, opening the door to earlier, more targeted diagnosis and care to help minimize serious complications such as stroke and heart failure.”

The Tempus ECG-AF was the first FDA-cleared ECG-AI device in Tempus’ portfolio of next-generation devices that identifies patients at risk for various cardiovascular conditions.

Tempus is a technology company advancing precision medicine through the practical application of AI in healthcare. With one of the world’s largest multimodal data libraries and an operating system to make that data accessible and useful, Tempus provides AI-enabled precision medicine solutions to physicians to deliver personalized patient care and facilitate the discovery, development, and delivery of optimal therapeutics.

Reference
¹ Tempus ECG-AF is intended for use to analyze recordings of 12-lead ECG devices and detect signs associated with a patient experiencing atrial fibrillation and/or atrial flutter (collectively referred to as AF) within the next 12 months. It is for use on resting 12-lead ECG recordings collected at a healthcare facility from patients: 65 years of age or older, without pre-existing or concurrent documentation of atrial fibrillation and/or atrial flutter, who do not have a pacemaker or implantable cardioverter defibrillator, and who did not have cardiac surgery within the preceding 30 days. Performance of repeated testing of the same patient over time has not been evaluated and results SHOULD NOT be used for patient monitoring. Tempus ECG-AF only analyzes ECG data. Results should be interpreted in conjunction with other diagnostic information, including the patient’s original ECG recordings and other tests, as well as the patient’s symptoms and clinical history. Tempus ECG-AF is not for use in patients with a history of AF, unless the AF occurred after a cardiac surgery procedure and resolved within 30 days of the procedure. It is not for use to assess risk of occurrence of AF related to cardiac surgery. Results do not describe a person’s overall risk of experiencing AF or serve as the sole basis for diagnosis of AF, and should not be used as the basis for treatment of AF. Results are not intended to rule-out AF or the need for follow-up.