Eko has won FDA clearance for a suite of algorithms that will allow its digital stethoscope to more accurately screen for heart conditions that include heart murmurs and atrial fibrillation (AFib) during routine physical exams.
Eko’s AI identifies heart murmurs with 87% sensitivity and 87% specificity. The company said 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, which affects more than five million Americans.
The AI has the ability to detect AFib with 99% sensitivity and 97% specificity when analyzing the 1-lead ECG tracing from the Eko DUO stethoscope. The integration of ECG into the stethoscope enables providers to quickly screen patients for serious arrhythmia during a standard physical exam.
The algorithm also 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.
“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 Co-Founder and CEO said in a 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.”
Eko is at the intersection of the cardiovascular market and AI. It joins several other companies in this space including iRhythm Technologies, which has developed the Zio Patch, a wearable technology to monitor heart rate activity.
iRhythm has been working closely with Verily Life Sciences’ for the Alphabet company’s prescription-only smartwatch. The device recently received a nod from FDA to measure irregular heartbeats.
Apple is perhaps one of the biggest companies at this intersection. In September of 2018 the Cupertino, CA-based put a huge spotlight on the space. It was at that time Apple received FDA clearance for an ECG app, a software-only mobile medical application that can classify whether there are signs of AFib, and another software-only mobile medical app analyzing pulse rates for irregular rhythms.