FDA clears new AI algorithm for 1-year AFib risk
Chicago-based Tempus AI has gained clearance from the U.S. Food and Drug Administration (FDA) for a new artificial intelligence (AI) algorithm that identifies patients who may face a heightened risk of experiencing atrial fibrillation (AFib).
The Tempus ECG-AF algorithm evaluates 12-lead electrocardiogram (ECG) results, alerting users when the patient could be at risk of experiencing AFib within the next 12 months. The company emphasized that the newly approved AI model should be used in conjunction with other data, including the patient’s original 12-lead ECG results. It was specifically designed for patients 65 years old and older with no prior history of AFib.
“We believe that there are too many patients who die from AFib-related causes unnecessarily due to underdiagnosis or undertreatment,” Brandon Fornwalt, MD, PhD, senior vice president of cardiology at Tempus, said in a prepared statement announcing the FDA clearance. “The clearance of Tempus ECG-AF allows us to better support clinicians in potentially finding patients much earlier, when treatments can be more effective.”
A busy year for cardiology AI continues
2024 has already been a busy year for the FDA when it comes to approving new AI models related to cardiology. The agency has already given a thumbs up to new algorithms from Tempus AI, Medicalgorithmics, AliveCor, Implicity, Eko Health ,Viz.ai and others in the first six months of the year alone.
Of course, this is nothing new for cardiology; the specialty has been a leader in healthcare AI since the beginning, trailing only radiology when it comes to FDA-approved algorithms. Click here for additional context on this growing trend.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.