Tyto Care 510(k) for Digital Stethoscope Cleared

FDA has cleared a Tyto Care Inc. 510(k) for its digital stethoscope, a device that will be part of the firm’s set of telehealth digital examination tools for examining the ears, throat, skin, heart, lungs, and temperature under a cloud-based platform with video conferencing. “By enabling a more comprehensive picture of the patient’s health and an enhanced remote diagnosis, Tyto Care is providing the critical missing link in the delivery of telehealth,” Tyto says.

“Until today, telehealth was limited because clinicians had to rely on phone or video conferencing only to examine and diagnose a patient, without the benefit of a physical exam,” the company says. “For the first time we are making it possible to closely replicate, from home, a face-to-face visit to the doctor’s office.” Examinations can be done in real time as part of a live video telehealth visit, or in advance of a telehealth session.