Tempus AI, Inc. (NASDAQ: TEM) announced it has received 510(k) clearance from the U.S. Food and Drug Administration for its Tempus ECG-Low EF software, an artificial intelligence-powered tool designed to identify patients who may have low left ventricular ejection fraction (LVEF) from standard electrocardiogram recordings.
The FDA clearance marks a significant milestone for Tempus's cardiovascular AI portfolio, with Tempus ECG-Low EF joining Tempus ECG-AF as the second FDA-cleared ECG-AI device in the company's growing suite of next-generation cardiovascular diagnostic tools.
Clinical Significance and Target Population
Ejection fraction measures the percentage of blood that the heart pumps out with each beat, and a reduced LVEF may indicate serious cardiovascular conditions including heart failure, cardiomyopathy, or damage from a prior heart attack. The Tempus ECG-Low EF software is specifically designed to analyze resting, non-ambulatory 12-lead ECG recordings and detect signs associated with having a low left ventricular ejection fraction defined as LVEF less than or equal to 40%.
The software is intended for use on clinical diagnostic ECG recordings collected at healthcare facilities from patients 40 years of age or older at risk of heart failure. This target population includes patients with atrial fibrillation, aortic stenosis, cardiomyopathy, myocardial infarction, diabetes, hypertension, mitral regurgitation, and ischemic heart disease.
"With Tempus ECG-Low EF, we're 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," said Brandon Fornwalt, MD, PhD, Senior Vice President of Cardiology at Tempus. "Detection of LVEF is essential for undiagnosed patients, and this technology enables us to deliver that capability at scale to transform patient care."
Technical Specifications and Limitations
The Tempus ECG-Low EF software analyzes ECG data and provides a binary output for clinical interpretation. However, the technology comes with specific limitations and requirements for proper use. The software is not intended to be a stand-alone diagnostic tool for cardiac conditions, should not be used for patient monitoring, and should not be used on ECGs with paced rhythms.
Results from the software must 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. A positive result may suggest the need for further clinical evaluation to establish a diagnosis of low LVEF, while patients receiving a negative result should continue to be evaluated according to current medical practice standards using all available clinical information.
Strategic Impact on AI-Driven Cardiology
The FDA clearance represents Tempus's continued expansion into AI-driven cardiovascular diagnostics. Fornwalt emphasized that "the addition of a second FDA-cleared Tempus ECG-AI solution reflects our continued commitment to advancing AI-driven cardiology."
Tempus positions itself as a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. The company operates one of the world's largest libraries of multimodal data and provides an operating system to make that data accessible and useful for AI-enabled precision medicine solutions.
The company's approach focuses on providing physicians with tools that learn as more data is gathered, with the goal that each patient benefits from the treatment of others who came before. This latest FDA clearance strengthens Tempus's position in the cardiovascular AI market and demonstrates the regulatory pathway for AI-powered diagnostic tools in cardiology.
