FDA approves handheld amblyopia screening device

REBIScan announced that the FDA cleared its Pediatric Vision Scanner (PVS) which can detect strabismus, amblyopia and other serious eye conditions in 2.5 seconds.

"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 David Hunter, MD, PhD, REBIScan co-founder and chief ophthalmologist at Boston Children's Hospital. "Independent studies published by our peers have shown the accuracy of the PVS far exceeds what we have seen from products currently on the market."

The PVS is designed to scan children as young as aged 2 using a concept patented by Children’s Hospital Boston called retinal birefringence.

A 5-year clinical trial conducted at Children’s Hospital Boston and Harvard Medical School showed that 97.3% of children deemed normal by the PVS had normal eyes, while nearly 100% of children who received a “refer” result had amblyopia, strabismus or vision loss requiring medical attention.

With brief training, any staff member in a medical office can operate the screener and interpret results.

Availability of the device will be limited over the coming months.