FDA clears algorithms used with digital stethoscopes – Med-Tech Innovation | Latest news for the medical device industry
The Food and Drug Administration (FDA) has cleared a suite of algorithms which can be used with Eko’s digital stethoscopes for the treatment of heart disease.
The algorithms aim to alert clinicians to the presence of heart murmurs and atrial fibrillation (AFib) during a physical examination, converting the classic stethoscope into an early detection tool.
Connor Landgraf, Eko’s co-founder and CEO, said: “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. Eko’s new ability to alert a provider to the presence of a heart murmur or atrial fibrillation during the standard physical exam brings that vision to life.”
Eko’s AI is able to identify heart murmurs, a leading symptom of valvular heart disease, with 87% sensitivity and 87% specificity. In comparison, a recent study revealed that using traditional stethoscopes, primary care physicians had a sensitivity of 43% and a specificity of 69% for detecting significant valvular heart disease.
The AI is also able to detect AFib with 99% sensitivity and 97% specificity when analysing the one-lead ECG tracing from the Eko DUO stethoscope. The integration of ECG into the stethoscope enables providers to screen patients for the serious arrhythmia during a standard physical exam.
Also, the Algorithm reports heart rate and QRS duration and identifies tachycardia and bradycardia, abnormally fast and slow heart rates, which can be indicative of heart disease or other health conditions such as thyroid disease.
Dr Patrick McCarthy, executive director of the Bluhm Cardiovascular Institute at Northwestern Medicine and member of Eko’s scientific advisory board, said: “Two centuries after its invention, the stethoscope is still the front line tool to detect cardiovascular disease. 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.”
Eko’s AFib and Murmur screening algorithms are the first in a suite of cardiac screening algorithms Eko plans to combine with its digital stethoscope devices. In December 2019, Eko announced the FDA had granted the company breakthrough status for a novel ECG-based algorithm that, if FDA-cleared, could provide a screening test for heart failure.