FDA Clears AI Model For Detecting Signs Of Heart Failure In ECGs

4 Oct 2023 • Anumana, a Massachusetts-based company, has received U.S. Food and Drug Administration (FDA) clearance for its new artificial intelligence (AI) model that identifies signs of low ejection fraction (LEF) in 12-lead electrocardiograms (ECGs). The ECG-AI LEF algorithm, developed as part of a collaboration with Mayo Clinic, was designed to help screen high-risk patients for heart failure.

It was built using data from more than 100,000 ECGs and 100,000 echocardiograms and has already been tested in a clinical setting on more than 40,000 patients. The AI model was then validated in a clinical trial involving 16,000 patients, producing a sensitivity of 84.5% and specificity of 83.6% when it came to spotting patients with an ejection fraction less than or equal to 40%.

Additionally, the Mayo Clinic conducted the prospective, randomized controlled EAGLE clinical trial that evaluated the use of an investigational version of the algorithm in routine clinical care of 22,641 adults by 120 primary care teams from 45 clinics or hospitals. The study demonstrated that ECG-AI LEF implementation improved clinician’s ability to diagnose LEF by 31% versus standard of care without increasing the overall rate of echocardiogram usage.

Anumana’s ECG-AI LEF fills an important unmet need—the lack of an easily accessible point-of-care, noninvasive, and inexpensive tool to screen for a weak heart pump,” Paul Friedman, MD, chair of the department of cardiovascular medicine at Mayo Clinic and chair of the Anumana Board of Advisors, said in a prepared statement. “It allows identification of otherwise hidden disease, for which many effective, lifesaving treatments are available—once the presence of the disease is known.”

Source: CI Today | Read full story

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