InTouch Health has announced it has received FDA 510(k) clearance with expanded indications for use for its range of Remote Presence acute care telemedicine devices, according to a news release.
The Remote Presence devices include RP-7i, RP-Lite, RP-Vantage and RP-Xpress, and the VisitOR1, which is sold by Karl Storz.
The expanded indications for use clear the Remote Presence devices to be used for pre-, peri-operative and post-surgical, cardiovascular, neurological, pre-natal, psychological and critical care assessments and examinations.
"With these expanded indications for use, InTouch Health's platform of telemedicine devices now has clearance for active patient monitoring in high acuity clinical environments with specific language clarifying the allowance of clinical applications of importance to customers in our core telestroke and teleICU markets," said Dr. Yulun Wang, chairman and CEO of InTouch Health, in the release. "This clearance raises the bar for regulatory compliance in acute care markets and we are proud to have achieved this regulatory objective. We are absolutely committed to stringent regulatory compliance, and we are pleased to provide customers the assurance of knowing that our telemedicine solutions have withstood vigorous testing and are fully compliant with FDA regulations."
InTouch Health is headquartered in Santa Barbara, Calif.
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