FDA Clearance

InTouch Health products are the only Class II telemedicine remote presence medical devices of their kind on the market that are cleared by the FDA for "active patient monitoring in high-acuity clinical environments where immediate clinical action may be required." This includes pre- and perioperative, post-surgical, cardiovascular, neurological, pre-natal, psychological and critical care environments as well as psychological and critical care assessments and examinations.

According to the FDA's recent MDDS (Medical Device Data Systems) final ruling, use of Class I medical and other non-medical products for conducting active patient monitoring constitutes off-label usage exposing the user to potential liability.

InTouch Health telemedicine devices are also cleared by the FDA for transmitting and receiving information over a high speed connection between patients, health professionals and critical transport teams outside hospital walls which supports use of the portable, RP-Xpress remote presence device, in particular, for acute pre- and post-hospital medical consults.