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FDA clears REBIScan’s Pediatric Vision Scanner

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The FDA has granted REBIScan market clearance through the de novo pathway for the Pediatric Vision Scanner, according to a press release.

The hand-held Pediatric Vision Scanner is designed to help physicians screen for amblyopia and strabismus in young children.

“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,” David Hunter, MD, PhD, co-developer of the device and co-founder of REBIScan, said in the release.

The company expects to have a limited release of the device in the coming months.