FDA OKs AF, Heart Murmur Algorithms for Eko's Digital Stethoscope

Megan Brooks

January 29, 2020

The US Food and Drug Administration (FDA) has cleared two algorithms from Eko for use with the company's digital stethoscope to screen for atrial fibrillation (AF) and heart murmurs during routine physical exams, marking the first AI-powered stethoscope.

Eko's AF and heart murmur screening algorithms are the first in a suite of cardiac screening algorithms the company plans to combine with its digital stethoscopes to assist providers in the detection of cardiovascular conditions.

Last December, the FDA granted Eko breakthrough status for a novel ECG-based algorithm designed to provide an easily accessible screening test for heart failure. Developed in collaboration with the Mayo Clinic, the algorithm analyzes 15 seconds of ECG data collected from the Eko DUO digital stethoscope during a physical exam and helps identify reduced left ventricular ejection fraction.

The new heart murmur algorithm has a sensitivity and specificity of 87% for detection, greater than the 43% sensitivity and 69% specificity for detecting significant valvular heart disease using traditional stethoscopes in primary care, according to a recent study, the company said in a news release.

The AF algorithm detects AF with 99% sensitivity and 97% specificity when analyzing the one-lead ECG tracing from the Eko DUO stethoscope. "The integration of ECG into the stethoscope enables providers to quickly screen patients for the serious arrhythmia during a standard physical exam," the company says.

The algorithm also reports heart rate and QRS duration and identifies tachycardia and bradycardia, which can be indicative of heart disease or other health conditions, such as thyroid disease.

"Two centuries after its invention, the stethoscope is still the front-line tool to detect cardiovascular disease," Patrick McCarthy, MD, executive director, Bluhm Cardiovascular Institute at Northwestern Medicine, Chicago, and member of Eko's scientific advisory board, according to the news release.

"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," McCarthy added.

"Our vision since day one has been to build seamless technology that helps providers more accurately detect heart disease, the leading killer in the world, by putting the ears of a cardiologist in any clinician's stethoscope," Connor Landgraf, Eko's CEO and cofounder, says in the news release.

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