Medical device company Eko got the greenlight from the FDA for its Class 2 medical device — digital stethoscope Eko CORE, according to a company statement. It wirelessly streams heart sounds to a smartphone app and integrates heart sounds directly into the patient’s electronic health record. The goal is to support physicians treatment of patients with cardiovascular disease.
One of the cool thing about digital stethoscopes is that they can record patients’ heart sounds and make it easier for physicians to share them for consults, for example. The app, which is available from iTunes app store, also provides a view of waveform of the heart sounds. The device itself is expected to retail for $199.
Eko has had a collaboration with the University of California San Francisco’s Department of Cardiology, which has led Eko’s ongoing clinical trial. The trial will be expanded to Stanford University Department of Medicine where internal medicine residents will use the device as part of a pilot.
Another product Eko has in the works is Eko is a clinical decision support algorithm. It will be included with the mobile app after undergoing a separate FDA review and completing trials, according to the company statement.
Earlier this year Eko raised a $2.8 million funding round that included music identification company Shazam’s co-founders, FOUNDER.org Founder and CEO, Michael Baum, Stanford University StartX Fund, and former senior advisor to the U.S. Secretary of Health and Human Services, John Noonan.
Eko’s isn’t the first digital stethoscope to get FDA clearance. Rijuven got FDA clearance two years ago. Stethoscopes have had few design modifications over the years. Electronic stethoscope have been around for years, but they have so far not made a big dent in the stethoscope market. Design limitations such as ambient sound that bleeds into the heart sound recordings have been a turn off for physicians.
