NEW YORK – Telehealth provider TytoCare has received CE Mark approval for its end-to-end telehealth solution. The clearance will allow the company to roll out the connected system, which includes an otoscope, stethoscope, camera and telehealth platform, immediately in Europe. “Receiving CE Mark approval is an important milestone for TytoCare and a major step in our continued strategic expansion into Europe and other new markets,” said Dedi Gilad, CEO and co-founder of TytoCare, in a statement. “European doctors are struggling to keep up with the increasing medical demand of an aging population and the rise of chronic illnesses. Tyto is uniquely positioned to ease this burden by replicating the quality of in-person doctor visits without any barriers to access such as transportation and wait time.” The roll out will take place through partnerships with telehealth companies, health systems and insurance providers. TytoCare received clearance from the U.S. Food and Drug Administration for its connected system in 2017. Exam data can be shared with a clinician in real-time as a live video telehealth visit or in advance of a telehealth session for a remote diagnosis.
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