Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, announced publication of successful multi-site validation of its software, which received U.S. Food and Drug Administration clearance in 2024 for predicting the one-year risk of atrial fibrillation or flutter (AF). The study, titled "Multi-Center Validation of an Artificial Intelligence-Enabled ECG Model to Predict 1-Year Risk of Atrial Fibrillation or Flutter," was recently published in Heart Rhythm.

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

This study evaluated the Tempus ECG-AF software¹ across three geographically distinct clinical sites. ECG data were aggregated, and patient charts were manually reviewed to identify eligible patients: aged 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 this technology.

“This study marks an important step toward shifting cardiac care from late-stage intervention to early risk detection,” said Brandon Fornwalt, MD, PhD, SVP of Cardiology at Tempus and a coauthor of the study. “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’ growing portfolio of next-generation devices designed to identify patients at risk for a variety of cardiovascular conditions.

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.