Tempus publishes validation study for FDA-cleared ECG AI model

Tempus AI Inc. (NASDAQ: TEM) announced the publication of a multi-center validation study for its artificial intelligence-enabled electrocardiogram software in Heart Rhythm journal. The software received U.S. Food and Drug Administration clearance in 2024 for predicting one-year risk of atrial fibrillation or flutter.

The study evaluated the Tempus ECG-AF software across three clinical sites, analyzing data from 4,017 patients aged 65 and older with no prior atrial fibrillation history and no pacemaker or defibrillator use. The AI-derived risk score met pre-specified performance thresholds, supporting the FDA clearance of the technology.

Atrial fibrillation is the most common cardiac arrhythmia and is associated with increased risk of stroke, heart failure and death. The condition can be difficult to detect because it is frequently asymptomatic and intermittent.

"The ability of our AI model to consistently predict atrial fibrillation across varied clinical environments highlights its potential as a dependable decision-support tool," said Brandon Fornwalt, senior vice president of cardiology at Tempus and study coauthor.

The Tempus ECG-AF software analyzes 12-lead ECG recordings to detect signs associated with patients experiencing atrial fibrillation within 12 months. The device is intended for use on resting ECG recordings from patients 65 years or older without pre-existing atrial fibrillation documentation, who do not have cardiac devices and did not have recent cardiac surgery.

Tempus described the ECG-AF as the first FDA-cleared ECG-AI device in its portfolio of cardiovascular diagnostic tools. The company develops AI-enabled precision medicine solutions using multimodal data libraries.

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