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FDA approves Tyto Care’s digital stethoscope

Tyto Care has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its digital stethoscope, which is part of the firm’s telehealth platform.

The firm’s telehealth solution includes advanced digital tools to examine ears, throat, skin, heart, lungs, and temperature. It also features cloud-based platform with video conferencing.

The firm is launching two new products, including TytoPro for clinicians to capture and share remote examination data, and conduct a specialist consultation or get a second opinion.

TytoHome has been designed for consumers to use at home to connect with a clinician. It features an advanced guidance technology that will allow to capture data at home.

Tyto Care CEO and co-founder Dedi Gilad said: “For the first time we are making it possible to closely replicate, from home, a face-to-face visit to the doctor’s office.”

Tyto Care’s advisory board chair Karen Rheuban said: “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.

“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.”

Established in 2012, the company secured around $18m funding from investors such as Cambia Health Solutions, Walgreens, Orbimed and Fosun Pharma.

Image: TytoCare, which guides a parent through a comprehensive remote medical exam for consultation with their physician, has been approved in the US. Photo: courtesy of Business Wire.