New Vision System for Tracking Eye Movement Gets FDA Clearance

The RightEye system is the first portable device for screening eye health by tracking eye movements.

RightEye LLC is focused on the development of eye-tracking technology to uncover vision performance and brain health issues. Its new RightEye system, which includes RightEye EyeQ™ tests, reports and training tools, was recently awarded 510(k) clearance () by the U.S. Food and Drug Administration for the recording, viewing and analysis of eye movements in support of identifying visual tracking impairment in patients.


The system is designed to track eye movements and correlate them to potential health issues, from functional vision issues to vision issues associated with learning difficulties, athletic performance and brain health.


The clearance was based on the results of a study of nearly 200 people, including some that had suffered traumatic brain injury (TBI) within one month and some that have no history of TBI. Patients moved their eyes back and forth as quickly and accurately as possible between two dots placed next to each other horizontally or vertically. The horizontal saccade test correctly identified people with concussion nearly 80% of the time, while the vertical saccade test was accurate over 60% of the time.

The ability of the device to detect small quick movements may enable it to differentiate between mild, moderate and severe concussions. It also provides a baseline result that allows measurement of patient responses to treatment.

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