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# FDA Clears REBIScan Pediatric Eye Scanner
- URL: https://www.fdaweb.com/fda-clears-rebiscan-pediatric-eye-scanner/
- Published: 2016-06-17T12:00:00.000Z
- Updated: 2026-09-14T21:10:33.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135974

FDA has cleared a REBIScan 510(k) for the Pediatric Vision Scanner, 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 the company. The submission was based on independent studies that have shown the accuracy of the device to be as high as 94%, which the company says “far exceeds” what is seen from products currently on the market.

The device uses a new technology — retinal birefringence scanning, which was co-invented by company founder David Hunter — to detect amblyopia and strabismus. Medical assistants in the pediatric office may operate the device to perform annual vision scans, the company says. The scanner can also reduce false referrals to ophthalmologists, it adds.