FDA clears digital stethoscope for US market
04 September 2015
The US Food and Drug Administration has cleared a digital stethoscope for the US market, that seeks to upgrade auscultation, the ancient medical practice of listening to the heartbeat of a patient.
The Eko Core, the new generation smartphone, streams heart sounds to a smartphone app which, in turn, saves the recorded beats to a patient's electronic medical record. The recorded heartbeat can be viewed as a heart-sound wave form and shared via a secure link with a cardiologist for a second opinion.
The mobile application that allows the transfer and visualisation of the sounds of a human heart is available on the Apple app store. The device, the app and the web platform built around it have been designed for compliance with the comprehensive patient-privacy law called HIPAA.
The Eko Core and its associated app are the first offerings of a Silicon Valley start-up founded by a team of UC Berkeley engineering and business school graduates.
The founder members of the company 25-year-old CEO Connor Landgraf, 23-year-old chief operating officer Jason Bellet, and 23-year-old Tyler Crouch, chief technical officer, are said to be the youngest team ever to receive FDA clearance for a Class II medical device.
|(Gang of three) CAPTION: Eko's co-founders: Jason Bellet (COO), Connor Landgraf (CEO), and Tyler Crouch (CTO)|
The new-generation stethoscope "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,'' according to Dr John Chorba, a cardiologist at University of California, San Francisco, who is leading an ongoing clinical trial of the Eko device.
The Los Angeles Times reported, Chorba, 34, who prefers the original stethoscope to new fangled technology, said though he was not inclined to use such features of the Eko Core as amplification, "there are many times I would like to be able to re-listen to a patient's heartbeat, and this gives me an opportunity to do that."
Internal medicine residents at Stanford University's Department of Medicine would be the first to use the device as part of an ongoing institutional pilot.
In 2013, a team of students at the Johns Hopkins University's Whiting School of Engineering designed a new stethoscope for NASA that delivers accurate heart- and body-sounds to medics trying to assess astronauts' health on long missions in noisy spacecraft. (See: New 'out of this world' space stethoscope valuable here on Earth, too).