We’ve written about Eko‘s digital stethoscope technology several times. Most recently in December 2019, we reported that the U.S. Food and Drug Administration granted Eko Breakthrough Device status for the artificial intelligence algorithm designed to detect heart failure. Breakthrough Device status accelerates regulatory review as a product progresses to marketability. In a welcome demonstration that bureaucratic systems can act swiftly at times, the FDA made another significant announcement regarding Eko at the end of January 2020.
On January 28, 2020, the FDA cleared Eko’s algorithms for use with the company’s digital stethoscopes to detect heart disease. Healthcare providers can now use the Eko products during routine physical exams to identify atrial fibrillation (AFib) and heart murmurs. In a recent clinical study, Eko’s AI identified heart murmurs with 87% sensitivity and 87% specificity. These percentages easily topped the performance of conventional stethoscopes; they resulted in 43% sensitivity and 69% specificity in recent testing. Eko’s DUO Digital Stethoscope AI also excelled in detecting AFib, scoring 99% sensitivity and 97% specificity. Additional Eko algorithm reporting includes heart rate and QRS duration, IDing tachycardia and bradycardia.
Fast track indeed! Eko’s status boost followed by the algorithm’s relatively rapid clearance for use by healthcare professionals isn’t an overnight success, though the timing might seem like it. We wrote about Eko’s work in 2015 when we covered the Eko Core digital stethoscope attachment for smartphones. Still, the FDA program to help bring important new technology to market sooner will benefit the companies that make them as well as patients and healthcare professionals.
