FDA clears new stethoscope for new age
The FDA has cleared Eko Core, a digital stethoscope designed by medical devices startup Eko Devices. Company founders call Eko Core "a next-generation" stethoscope – billed as the only one on the market to wirelessly stream heart sounds to a HIPAA-compliant smartphone app. It is also the first to integrate heart sounds directly into the patient's EHR.
The value proposition? It enables clinicians to better address a cardiovascular disease crisis that affects one in four people worldwide.
Eko Core is also the only stethoscope available that enables clinicians to switch between analog and digital modes, according to company executives. The Bluetooth-connected mobile app, available on the Apple App Store, enables clinicians to view a heart sound waveform, save heart sounds directly to a patient's electronic health record and securely collaborate with a cardiologist for a second opinion.
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The University of California, San Francisco's Department of Cardiology is leading Eko's ongoing clinical trial. Stanford University Department of Medicine will be the first institution in the country to deploy the device to its internal medicine residents as part of an institutional pilot.
"The stethoscope is an iconic and universal part of the medical practice, a tool which nearly every doctor, nurse and student learns to use," said John Chorba, MD, cardiologist at the University of California, San Francisco, in a statement. "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."
Eko is also developing a decision support algorithm – a "Shazam for Heartbeats – that will be included with the mobile app after undergoing a separate FDA review and completing trials. Shazam's co-founders invested in Eko's $2.8 million funding round alongside FOUNDER.org founder and CEO, Michael Baum; Stanford University StartX Fund; and former senior adviser to the U.S. Secretary of Health and Human Services, John Noonan.
"As a team of young entrepreneurs, Eko has the ability to introduce delightful software and advanced decision support tools on top of the devices physicians already know and, most importantly, trust," said Connor Landgraf, Eko's co-founder and CEO, in a statement. "We've started by pairing the oldest and the newest tools in the medical toolkit – the stethoscope and the smartphone."
Founded in 2013 at the University of California, Berkeley SkyDeck accelerator, the company has been has received the American Heart Association's Emerging Health Technology Award and participated in the Stanford University StartX Med and FOUNDER.org accelerator programs.
Landgraf and Eko's additional co-founders, Tyler Crouch, CTO, and Jason Bellet, COO, all UC Berkeley engineering and business school graduates, are considered the youngest team to receive FDA clearance for a Class II medical device.