Tempus has announced the publication of successful multi-site validation of its artificial intelligence (AI)-enabled electrocardiogram (ECG) software, which received US Food and Drug Administration (FDA) clearance in 2024 for predicting the one-year risk of atrial fibrillation (AF) or flutter.
The study—recently published in Heart Rhythm—evaluated the Tempus ECG-AF software across three geographically distinct clinical sites. ECG data were aggregated, and patient charts were manually reviewed to identify eligible patients—those aged 65 years 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 prespecified performance thresholds, and the resulting data supported Tempus’ US 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, senior vice president of cardiology at Tempus and a co-author of the study. “The ability of our AI model to consistently predict AF 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 minimise serious complications, such as stroke and heart failure.”
The Tempus ECG-AF was the first US FDA-cleared ECG-AI device in the company’s growing portfolio of next-generation devices designed to identify patients at risk for a variety of cardiovascular conditions.
