Eye-Sync Granted FDA Breakthrough Device Designation for AI Eye Tracking Tool

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Eye-Sync, an objective eye-tracking platform created by SyncThink, a neurotechnology and brain health analytics company, has received breakthrough device designation from the U.S. Food and Drug Administration (FDA) today.

The platform initially gained FDA clearance in March 2016 for recording, viewing and analyzing eye movements to identify visual tracking impairment.

>> READ: Objective Eye Tracking Tool for Concussion Granted FDA Approval

Eye-Sync is a modified virtual reality headset with infrared cameras that connect wirelessly and securely to a tablet that displays the results to a clinician within 60 seconds. The platform runs assessments and uses peer-reviewed research to detect abnormal patterns that indicate visual impairments in need of targeted treatment intervention.

Currently, Eye-Sync is used to assist clinicians in evaluating visual impairments, monitoring recovery and supporting the rehabilitation of ocular-motor and ocular-vestibular deficits. The tool can be used to provide objective measurements to aid in the assessment of concussion.

“With millions of concussions occurring each year, the need for a rapid, mobile and, most importantly, objective metric for impairment and recovery is clear and we are thrilled that the FDA is recognizing the importance of this work,” said Laura Yecies, CEO of SyncThink.

The breakthrough device program recognizes medical devices and products that can provide more effective and timely treatment or diagnosis of life-threatening conditions.

SyncThink works with the Golden State Warriors, the Pac-12 Conference and Stanford Children’s Hospital, among others.

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