FDA clears Eko Devices smartphone-connected stethoscope and app

By Aditi Pai
06:37 am

EkoBerkeley, California-based Eko Devices has received FDA 510(k) clearance for its smartphone-enabled stethoscope, called Eko Core as well as the companion smartphone app.

Eko Devices, which describes itself as a "Shazam for heartbeats", has previously received an investment from two Shazam cofounders, as well as Founder.org, Stanford StartX, former HHS advisor John Noonan. The company has raised at least $2.8 million to date.

The device hooks on to an analog stethoscope, records the sound, and sends data to the app via Bluetooth so that clinicians can visualize, record, listen to, and analyze heart sounds.The app will also capture a waveform called a phonocardiogram so clinicians can review the heart’s sound in real time, to identify abnormalities. Clinicians can use the app or web portal to attach heart sound reports and recordings to certain electronic health records -- the device will initially integrate with drchrono, but the company is planning to add integrations with other EHRs too.

"The plan here is to take digital heart sounds, make it part of the patient record, make it easy for doctors to share for cardiology referrals, to save and analyze at a later point," Eko Devices COO Jason Bellet told MobiHealthNews. "And in 2015, in the digital age, you have heart sounds from a patient from pediatrics, when they were 3, until they’re 27. We now have the ability with big data to trend that, to analyze it, to actually provide clinicians analytics above and beyond just listening to it."

Eko Core is now available for sale on the company's website. Clinicians can purchase the Eko Core for $199, or they can buy a bundle digital stethoscope for $299, which includes Eko Core as well as an analog stethoscope.

Eko is working on a separate FDA clearance for a decision support algorithm that is currently being researched at the University of California San Francisco.

"With UCSF, we are working with two cardiologists at San Francisco General Hospital, and they are doing a 200-patient study of incoming patients into the echo lab where they’re recording their heart sounds with our Eko Core," Bellet explained. "And over the course of about six months, they'll gather a relatively large data set of recorded heart sounds that have been analyzed by cardiologists and then we’ll run that against our algorithm that we’re developing to compare the accuracy of a cardiologist versus our algorithm. The goal being that we would love to hit sensitivity and specificity of a cardiologist."

Eko Core will also be deployed to seven of Stanford University Department of Medicine's internal medicine residents as part of a yearlong ongoing institutional pilot.


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