FDA clears Eko’s digital stethoscope

Eko Core

FDA has cleared the digital stethoscope Eko CORE to be used as a Class 2 medical device. The CORE can wirelessly stream heart sounds to a smartphone app and integrate heart sounds directly into the patient’s electronic health record to support physicians treatment of patients with cardiovascular disease. It is expected to retail for $199.

By digitizing heart sounds, patients are able to send them to their doctors, who can further share them for consults. The companion app also provides a view of waveform of the heart sounds.

Eko has been collaborating 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.

Beyond the device itself, the company is also working on a clinical decision support algorithm that will be included with the mobile app after undergoing a separate FDA review and completing trials.

Earlier this year Eko raised a $2 million in a round that included 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.

[Via: MedCityNews]