FDA clears AI tool for detecting undiagnosed heart valve disease in ECGs
Tempus AI has received U.S. Food and Drug Administration (FDA) clearance for a new artificial intelligence (AI) tool designed to evaluate standard 12-lead resting electrocardiograms (ECGs) for signs of undiagnosed mitral regurgitation (MR).
The newly cleared software, Tempus ECG-MR, identifies signs of moderate or severe MR and then flags clinicians to ensure the patient receives follow-up medical imaging as needed. It was built to assess diagnostic ECG recordings of any patients 65 years old or older who face a risk of developing cardiovascular disease.
“A standard ECG contains far more information than we have traditionally been able to use,” Brandon Fornwalt, MD, PhD, senior vice president of cardiology at Tempus, said in a statement. “With the fourth FDA-cleared Tempus ECG-AI product, we’re building a growing portfolio that can identify signals across numerous types of heart and vascular disease from the same ECG, helping provide clinicians with more actionable information from a test already embedded in everyday care.”
Tempus gaining more and more momentum
This is the second FDA clearance in just two months for Chicago-based Tempus. The agency cleared Tempus ECG-PH, built to identify signs of pulmonary hypertension in 12-lead ECGs, back in August.
Tempus has been busy in other ways as well. The company partnered with Medtronic to explore how AI can boost transcatheter aortic valve replacement care, for example, and then the U.S. government named Tempus part of its Agentic AI-EnableD CardioVascular CAre TransfOrmation (ADVOCATE) program.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.