Eko announced today that it won FDA clearance for its suite of algorithms that combine with the company’s digital stethoscopes to screen for heart conditions during routine physical exams.
The San Francisco-based company develops an artificial intelligence-powered, cloud-based software application designed to analyze electrocardiogram (ECG) and heart sound/phonocardiogram (PCG) data, using signal processing and convolutional neural networks.
Eko’s software is not intended as a sole means of diagnosis, but it is intended to offer physicians support as they evaluate patient heart sounds and ECGs. The algorithms are designed to detect suspected murmurs, the presence of atrial fibrillation (AFib) and normal sinus rhythm.
The algorithm received FDA breakthrough device designation in December 2019 and is able to detect AFib with 99% sensitivity and 97% specificity, according to a news release. Eko said it can also identify murmurs with 87% sensitivity and 87% specificity.
“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 co-founder & CEO Connor Landgraf said in the news release. “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.”
“Two centuries after its invention, the stethoscope is still the front line tool to detect cardiovascular disease,” added Nortwestern Medicine’s Bluhm Cardiovascular Institute executive director and Eko scientific advisory board member Dr. Patrick McCarthy. “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.”
