Tempus AI Publishes Multi-Site Validation Study for Atrial Fibrillation Risk Prediction
Tempus AI announced publication of a 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. 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. 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.
