FDA Clears Smart Stethoscope From Eko Devices

Finally, a stethoscope for the 21st century.

The U.S. Food and Drug Administration has cleared the Eko Core, a product the company describes as a next-generation digital stethoscope. The Eko Core is reportedly the only stethoscope on the market to wirelessly stream heart sounds to an HIPAA-compliant smartphone app and web portal, and the first to integrate heart sounds directly into a patient’s electronic health record.

Using the $199 device, which began selling last week, doctors insert the Eko Core into the tubing of a traditional device to chart patients’ heartbeats. Eko also will sell a smart stethoscope for doctors who prefer to abandon their analog devices entirely; the produt is priced at $299.

“The stethoscope is an iconic and universal part of medical practice, a tool which nearly every doctor, nurse and student learns to use,” said John Chorba, M.D., cardiologist at the University of California-San Francisco. “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.”

The University of California-San Francisco’s Cardiology Department is participating in Eko’s ongoing clinical trial of the smart stethoscope. Nearby Stanford University’s Department of Medicine is slated to be the nation’s first healthcare institution to deploy the device to its internal medicine residents as part of an ongoing institutional pilot, Eko executives said.

“It’s the first time the oldest and newest tools in medical toolkit are being married,” said 23-year-old Jason Bellet, a co-founder and chief operating officer of Eko Devices. “We can track [heartbeats] over time — from childhood to adulthood.”

Bellet admits the Eko Core is not the first smart stethoscope on the market, but he said the device is the first to connect to a smartphone and wirelessly transfer a heart recording. In a news release announcing FDA clearance, company officials said Bellet and fellow co-founders Connor Landgraf (CEO) and Tyler Crouch (chief technology officer) are considered the youngest development team to receive FDA clearance for a Class II medical device.

“As a team of young entrepreneurs, Eko has the ability to introduce software and advanced decision support tools on top of the devices physicians already know and, most importantly, trust,” Landgraf noted. “We’ve started by pairing the oldest and the newst tools in the medical toolkit — the stethoscope and the smartphone.”

While much of the medical field has gone digital, it’s been a slow transition for the nearly 200-year-old stethoscope.

“It has been stuck in the analog world,” said Charanjit S. Rihal, M.D., chairman of Cardiovascular Diseases at the Mayo Clinic. “With heart sounds, even if you’re good at examining patients … then what? It’s in our heads, we make diagrams, but a year later, do [doctors] really remember what you heard? The answer is they cannot.”

Eko, which has received $2.8 million in funding, is just beginning its cardiovascular innovations.

“The real value is if engineers can figure out ways to analyze the sounds using algorithms,” said Rihal, who joined Eko as an adviser.

And that’s exactly what Eko is looking to do. The two hospital clinical trials will pool heartbeat data from 200 children and 200 adults. This data will be analyzed and tested to help develop a Shazam-like heartbeat functionality that Eko is building. It will undergo separate FDA-testing, which is slated for early 2016.

Founded in 2013 at the University of California-Berkeley SkyDeck accelerator, Eko Devices uses mobile and cloud computing to develop medical products.