TytoCare gets FDA clearance for digital stethoscope

By Heather Mack
11:53 pm

Israel-based medical device maker TytoCare has received FDA 510(k) clearance for its digital stethoscope, joining the company's ecosystem of connected tools for remote medical examinations.

The company also offers several FDA Class 1 devices –  a connected otoscope for ear examinations, a high-resolution camera, and a thermometer that uses the forehead to get a reading. 

The stethoscope pairs with a smartphone and allows users to examine the ears, throat, skin, heart, lungs and temperature. Data will be captured, stored and shared via a cloud-based telehealth platform with video conferencing. Examinations can be done in real time or in advance of a telehealth visit. 

"This was the last element for our current offering to create a more complete way to conduct full examinations at home," TytoCare CEO and cofounder Dedi Gilad told MobiHealthNews. "As we move forward, we plan to bring in additional functionality to replicate the primary care visit."
TytoCare, which was founded in 2012 by Gilad and Ofer Tzadik, is also releasing two comprehensive products, TytoHome and TytoPro, and has opened its API to connect with third party devices under their TytoClinic offering. TytoHome is the direct to consumer offering and allows users to connect via the telehealth platform with a clinician to conduct a remote examination. TytoPro, which is targeted at healthcare professionals, allows for the capture and transfer of remote patient data, specialist consultation, or a simple second opinion.

The company is seeking to expand beyond current telemedicine offerings that rely on phone or video only, without clinical information that comes from physical exam tools.

In 2014, TytoCare told MobiHealthNews they were exploring multiple verticals, including the “multi-patient environment,” such as self-service kiosks, retail clinics or in employer’s offices, which still appears to be the plan. Last year, after an $11 million funding round, the company said they planned to partner with a telemedicine company that has a physician service, and the company is currently looking to partner with large health systems, physician groups and telehealth companies to roll out the device

Dr. Karen S. Rheuban, the chair of TytoCare’s Advisor Board and past president of the American Telemedicine Association, said the company’s offering aims to meet the standards of an in-person visit.

“By enabling a physical examination that virtually replicates an in-person visit, TytoCare will greatly enhance the ability of school-based clinics, nurses, home health providers, patients and family caregivers to connect and share medical information, “ Rheuban said in a statement. “The use of digital technologies that support high quality remote examinations, when integrated into care delivery models that enhance access both within the context of the medical home and in other settings, promises to transform how patients are treated today.”


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