The US Food and Drug Administration (FDA) has granted 510(k) clearance for Tempus AI鈥檚 ECG-Low (ejection fraction) EF software.
This software utilises AI to detect individuals with a low left ventricular ejection fraction (LVEF).
It is the latest addition to the company鈥檚 suite of ECG-AI devices, designed to detect at-risk patients of various cardiovascular conditions.
Tempus鈥� ECG-AI solutions are said to work with current ECG platforms and electronic health records (EHRs), integrating AI insights directly into clinical workflows.
The EF model is trained on data from over 930,000 ECGs and more than 170,000 individuals.
The company noted that for those who obtain a positive outcome from Tempus’ ECG-Low EF test, the LVEF of 40% or lower will be identified in nearly two in five subjects when assessed by echocardiogram.
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By GlobalDataA minimised LVEF potentially indicates cardiomyopathy, heart failure, or damage from a previous heart attack.
The software is designed for analysing resting, non-ambulatory 12-lead ECG recordings in a clinical setting.
It is intended for those who are aged 40 years or above with heart failure risk, including those with conditions such as aortic stenosis, atrial fibrillation, and diabetes.
Tempus noted that the software offers a binary output for interpretation and is not designed to function as an independent diagnostic instrument for cardiac conditions.
Additionally, it should not be used for monitoring of patients or on ECGs with paced rhythms.
Outcomes from the Tempus ECG-Low EF should be considered alongside other diagnostic information for a comprehensive clinical evaluation.
Tempus cardiology senior vice-president Brandon Fornwalt said: 鈥淲ith Tempus ECG-Low EF, we鈥檙e adding another powerful tool to the hands of clinicians to help them identify patients at risk for serious cardiovascular conditions much earlier in their care journey.
鈥淒etection of LVEF is essential for undiagnosed patients, and this technology enables us to deliver that capability at scale to transform patient care. The addition of a second FDA-cleared Tempus ECG-AI solution reflects our continued commitment to advancing AI-driven cardiology.鈥�
In May 2025, Tempus AI announced the expansion of its collaboration with Verastem Oncology to develop a companion diagnostic for the latter鈥檚 KRAS-mutant recurrent low-grade serous ovarian cancer (LGSOC) combination treatment.
