Startups

TytoCare gets FDA clearance for digital telemedicine stethoscope

TytoCare will bundle the stethoscope with other FDA-listed medical devices for healthcare professionals or even consumers to initiate telehealth exams.

TytoCares TytoHome device

TytoCare has received U.S. Food and Drug Administration 510(k) clearance for its digital stethoscope, allowing the startup to package an entire telehealth kit for remote examinations and diagnoses.

TytoCare, which is co-headquartered in New York City and Netanya, Israel, will bundle the stethoscope with other FDA-listed medical devices for healthcare professionals or even consumers to initiate telehealth exams. “We think this is the basic kit you need” to do telemedicine,” CEO and Co-Founder Dedi Gilad said in advance of the Wednesday announcement.

The kit actually is two different, newly introduced products, TytoPro and TytoHome. The former is built for clinicians who want to offer remote exams to patients, consult with specialists via telemedicine or get second opinions. TytoHome will be offered to consumers indirectly, through provider or perhaps employer partners.

“Some of the components, ruggedness and software differ,” Gilad said of the two versions. So does the price. TytoCare has priced the TytoPro kit at $999 plus a monthly service charge that varies by the level of integration and service ordered, while the TytoHome version will go for $299 plus monthly fees, he said.

TytoHome also is the name of a consumer-friendly handheld diagnostic device the vendor has offered for more than a year. That device is part of the new TytoHome package.

Initially, TytoCare will follow a B2B2C model for both products and is targeting a wide range of healthcare providers that might be interested in offering telehealth options. Potential customers include health systems, physician practices, home health agencies, nursing homes, school clinics and retail clinics.

Gilad said that the kits could be packaged in many ways. “It can go with a nurse in a bag,” he suggested. The technology also could be offered as a “mobile clinic” or built into kiosks — though, given the failure of telemedicine kiosk-maker HealthSpot late last year, TytoCare is not keen on the idea of making such bulky units itself, he said.

Ease of use was a major consideration in the development of the system. “Tyto was built from day 1 for consumers,” Gilad said. For now, consumers will only be able to buy the home kits through partners, though the company hopes to debut a direct-to-consumer option in the latter part of 2017.

Investors in TytoCare include Cambia Health Solutions, OrbiMed Advisors, Walgreens, Fosun Pharma and LionBird. Among the company’s advisors is Dr. Karen Rheuban, for whom the University of Virginia’s Center for Telehealth is named.

Photo: TytoCare

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