FDA clears AI algorithms for detecting AFib, heart murmurs
The Food and Drug Administration has given clearance to algorithms for the detection of atrial fibrillation and heart murmurs, when used in combination with a digital stethoscope.
Developed by digital health vendor Eko, the company contends that their artificial intelligence-powered stethoscope is the first to screen for these serious cardiovascular conditions and will enable providers to make more accurate patient diagnoses during routine physical exams.
According to Connor Landgraf, Eko’s co-founder and CEO, the company’s AI software puts the “ears of a cardiologist” in a clinician’s stethoscope by accurately analyzing electrocardiogram and heart phonocardiogram (heart sound) data.
“We interpret those (cardiac data) to identify whether a patient has a murmur in a heart sound or whether they have an arrhythmia in the ECG,” says Landgraf. “What our technology does is allow the clinician to do a very quick screening test in the office that is highly accurate.”
When analyzing the one-lead ECG tracing from the Eko DUO stethoscope, the AI is able to detect AFib with 99 percent sensitivity and 97 percent specificity, notes Landgraf. At the same time, he points out that Eko’s AI identifies heart murmurs with 87 percent sensitivity and 87 percent specificity.
Northwestern Medicine, which helped Eko to build the algorithms and to test them, served as a clinical study site for the technology.
“Two centuries after its invention, the stethoscope is still the front-line tool to detect cardiovascular disease,” says Patrick McCarthy, MD, executive director of the Bluhm Cardiovascular Institute at Northwestern Medicine and a member of the Eko scientific advisory board. “Eko’s development of artificial intelligence algorithms to help clinicians better interpret sounds, identify arrhythmias and detect heart murmurs during a physical exam is going to make a huge difference in our ability to care for patients.”
In December, Eko announced that an ECG-based algorithm—developed in collaboration with the Mayo Clinic—was granted “breakthrough device” designation by the FDA and, if cleared by the agency, could offer an easy and accessible screening test for heart failure.
The FDA’s voluntary Breakthrough Devices Program—first authorized in late 2016—seeks 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 a disease or condition that have significant advantages over existing treatment or diagnostic alternatives.
Going forward, Landgraf says Eko’s AFib and heart murmur algorithms are the first in a suite of cardiac screening algorithms that the company plans to combine with its digital stethoscope.
“You can’t beat the traditional stethoscope in terms of its simplicity and ability to quickly determine how a patient’s heart is functioning—and, what we want to do with this digital augmentation is to give clinicians so much more data and insight,” he adds. “We really want to be able to give every frontline clinician the confidence of a cardiologist.”