Digital Stethoscope That Links with EHR Gets FDA Clearance

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The Food and Drug Administration has approved use of a digital stethoscope that can integrate heart sounds into a patient’s electronic health record.

Called Eko Core, the stethoscope from startup vendor Eko Devices in San Francisco wirelessly streams heart sounds to a HIPAA-compliant smartphone app that is available in the Apple App Store.

Because patient heart sounds can be integrated directly with EHRs, the company says their mobile solution enables “more seamless cardiology referrals, documentation, and cardiac monitoring.”  In addition, the vendor claims Eko Core is the only stethoscope available that enables clinicians to switch between analog and digital modes.

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“The beauty of the Eko Core is that it captures the heart sounds in a streamlined way that has never been done before, interfacing seamlessly into our traditional exam without requiring any extra effort,” said John Chorba, M.D., a cardiologist at the University of California, San Francisco, in a written statement.

Currently, the University of California, San Francisco’s Department of Cardiology is conducting a clinical trial of Eko Core and Stanford University’s Department of Medicine will be the first institution in the country to deploy the FDA-cleared Class II medical device to its internal medicine residents as part of a pilot.

Founded in 2013 by University of California-Berkeley engineering and business school graduates, Eko Devices has received the American Heart Association’s Emerging Health Technology Award and participated in the Stanford University StartX Med and accelerator programs.

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