The approval allows Tyto Care will to release its comprehensive solution that includes an otoscope, stethoscope, digital camera, and telehealth platform across Europe.

The company stated that the roll out will take place partnerships with telehealth companies, health systems, and insurance providers.

After securing FDA clearance and product launch in the US, last year, the company claims to have gained traction with major US health systems, telehealth companies, large private practices, and employers.

Tyto’s products include a a hand-held modular examination tool to remotely examine the heart, lungs, skin, ears, throat, and abdomen.

Exam data can be shared in real time with a clinician as a live video telehealth visit or in advance of a telehealth session (exam and forward) for a remote diagnosis. The platform includes a self-guidance technology that is easy to capture and examine data remotely.

Tyto Care CEO and co-founder Dedi Gilad said: “Receiving CE Mark approval is an important milestone for Tyto Care, and a major step in our continued strategic expansion into Europe and other new markets. European doctors are struggling to keep up with the increasing medical demand of an ageing population and the rise of chronic illnesses.

“Tyto is uniquely positioned to ease this burden by replicating the quality of in-person doctors’ visits without any barriers to access such as transportation and wait time. We look forward to working with European partners to provide this critical missing link and transform the delivery of traditional primary care.”

The company had recently secured funding from Ping An Global Voyager Fund. It has helped propel the company to enter both European and Asian markets, to deliver telehealth experience consumers across the world. Tyto Care stated that it will focus on key market verticals including health systems, providers, and payers.