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AI heart failure algorithm receives FDA ‘breakthrough device’ designation

An echocardiogram-based algorithm developed by digital health vendor Eko, in collaboration with the Mayo Clinic, has been granted “breakthrough device” designation by the Food and Drug Administration.

The FDA’s Breakthrough Devices Program—a voluntary program—was first authorized in late 2016 to preserve the statutory standards for premarket approval, 510(k) clearance and De Novo marketing authorization, while providing timely access to new solutions for treating or diagnosing disease or condition that have significant advantages over existing treatment or diagnostic alternatives.

The provider-vendor partnership has combined Mayo’s machine-learning algorithm and cardiovascular database—which contains millions of ECGs and healthcare screenings—with Eko’s DUO smart stethoscope and software platform.

The machine learning algorithm, which analyzes 15 seconds of ECG data collected from Eko’s digital stethoscope during a standard physical exam, screens patients for low ejection fraction to determine if there are problems with the heart’s pumping function.

“A low ejection fraction means that the heart pump is weak, which can lead to shortness of breath, swelling, exercise intolerance or sudden death, so it is important to identify, as many treatments exist,” says Paul Friedman, MD, chair of the Department of Cardiovascular Medicine at the Mayo Clinic in Rochester, Minn.

“This technology gives physicians a tool to detect heart disease earlier and before it develops into a more serious illness,” adds Friedman, who—along with the Mayo Clinic—has a financial interest in the technology. “In effect, by imbedding the technology in a commonly used clinical tool—the stethoscope—all caregivers carry some of the diagnostic prowess of an expert cardiologist with them.”

In 2017, Eko received FDA clearance to market DUO, which combines ECG and digital stethoscope technology into a handheld device. According to the company, the problem with echocardiography is that it is an expensive and time-consuming medical imaging test using ultrasound that is less accessible than a doctor with a stethoscope.

“The Breakthrough Device designation recognizes the vast unmet clinical needs in identifying heart failure early in patients, whether it be due to cost, inaccessibility or misdiagnosis,” said Connor Landgraf, CEO and co-founder of Eko. “We look forward to working with the FDA to bring this algorithm to patients and to give clinicians a new tool to screen for low ejection fraction.”

Revenue from commercialization of the product will be used to support the Mayo Clinic’s not-for-profit mission in patient care, education and research, according to the healthcare organization.

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