BOSTON, MA--(Marketwired - June 16, 2016) - REBIScan, Inc., developer of advanced ocular scanning devices, announced today that the U.S. Food and Drug Administration has awarded market clearance through the "de novo" pathway to the company's flagship product, the Pediatric Vision Scanner (PVS). The PVS, a handheld device, is 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. "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," said David Hunter, MD, PhD, Ophthalmologist-in-Chief at Boston Children's Hospital, who co-developed the PVS and is REBIScan's co-founder. "This is indeed exciting news for the visual health of children around the world."
"The FDA's decision is a milestone for the company, but also for the thousands of care providers who are seeking better ways to detect these conditions at a young age," added REBIScan CEO Justin Shaka.
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.
"It is a shame that in today's world we have so many children losing sight simply for lack of treatment. With the PVS we will have a tool that can flag these kids and save their sight," said Dr. Hunter. "Independent studies published by our peers have shown the accuracy of the PVS to be as high as 94%, which far exceeds what we have seen from products currently on the market."
REBIScan is targeting a limited release of devices over the coming months. "We are working with a great team to deliver a great product, and this careful rollout will ensure a positive impact on children's health," said Mr. Shaka.
REBIScan is a medical device startup based in Boston, Massachusetts. In addition to developing the Pediatric Vision Scanner, the company has developed an educational app, BabySee, for parents to simulate their child's visual development. REBIScan is also developing other ocular scanning technology including a new tool for diagnosing traumatic brain injury.
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