The U.S. Food and Drug Administration has awarded market clearance through the “de novo” pathway to REBIScan, Inc.’s Pediatric Vision Scanner (PVS), a handheld device designed to help physicians screen for amblyopia (“lazy eye”) and strabismus (misaligned eyes) in young children, as early as preschool age when the condition is easiest to treat.
Amblyopia and strabismus are the leading cause of vision loss in children. According to David Hunter, MD, PhD, chief ophthalmologist at Boston Children’s Hospital, one in 20 children is silently losing sight from an eye condition that cannot be seen by parents and is not easily diagnosed by pediatricians.
Each year, hundreds of thousands of children permanently lose sight due to lack of detection of amblyopia and strabismus, yet with early detection they can be treated with glasses or an eye patch.
Published independent peer studies have shown the accuracy of the PVS to be as high as 94 percent, exceeding results from products currently on the market, according to the company.
REBIScan, a startup based in Boston, plans a limited release of devices in the coming months.