CHICAGO–(BUSINESS WIRE)–Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, today 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.
1Tempus 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.
About Tempus
Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the world’s largest libraries of multimodal data, 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 in parallel facilitates discovery, development and delivery of optimal therapeutics. The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data. For more information, visit www.tempus.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended, about Tempus and Tempus’ industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release are forward-looking statements, including, but not limited to, statements regarding expected outcomes and statements regarding the quality of Tempus’ research and publications; the contributions of Tempus’ research and findings to the larger scientific community; and the use of Tempus’ products and services to advance clinical care for patients. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “going to,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Tempus cautions you that the foregoing may not include all of the forward-looking statements made in this press release.
You should not rely on forward-looking statements as predictions of future events. Tempus has based the forward-looking statements contained in this press release primarily on its current expectations and projections about future events and trends that it believes may affect Tempus’ business, financial condition, results of operations and prospects. These forward-looking statements are subject to risks and uncertainties related to: the intended use of Tempus’ products and services; Tempus’ financial performance; the ability to attract and retain customers and partners; managing Tempus’ growth and future expenses; competition and new market entrants; compliance with new laws, regulations and executive actions, including any evolving regulations in the artificial intelligence space; the ability to maintain, protect and enhance Tempus’ intellectual property; the ability to attract and retain qualified team members and key personnel; the ability to repay or refinance outstanding debt, or to access additional financing; future acquisitions, divestitures or investments; the potential adverse impact of climate change, natural disasters, health epidemics, macroeconomic conditions, and war or other armed conflict, as well as risks, uncertainties, and other factors described in the section titled “Risk Factors” in Tempus’ Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission (“SEC”) on February 24, 2026, as well as in other filings Tempus may make with the SEC in the future. In addition, any forward-looking statements contained in this press release are based on assumptions that Tempus believes to be reasonable as of this date. Tempus undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release or to reflect new information or the occurrence of unanticipated events, except as required by law.
Contacts
Tempus
Hanah Heintzelman
[email protected]
