Neurotechnology company SyncThink’s eye-tracking platform has been granted U.S. Food and Drug Administration designation as a breakthrough device.
The designation, which the FDA finalized guidance around earlier this year, is meant to open a pathway to approval for novel medical products that treat or diagnose life-threatening or irreversibly debilitating diseases or conditions. For SyncThink, the designation is a recognition by the FDA that its technology has the ability to solve an important and unmet need for providing objective measurements to aid in the assessment of concussions.
SyncThink uses a proprietary eye-tracking platform called Eye-Sync to help diagnose concussions and rehabilitate people suffering from them. The platform is currently used to assist clinicians in evaluating visual impairments, monitoring recovery, and rehabilitating ocular-motor and ocular-vestibular deficits. Eye-Sync also tracks brain analytics that are intended to help optimize cognitive performance.
“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 SyncThink CEO Laura Yecies, in a statement.
The FDA program works to shorten the timeframe within which breakthrough medical devices are approved. According to Yecies, the designation will help SyncThink facilitate broader applications for its Eye-Sync platform while continuing to improve its use for the public.
The Eye-Sync platform gained initial FDA Clearance in March of 2016 for recording, viewing, and analyzing eye movements for the identification of visual tracking impairment in humans.
Since then, SyncThink has started working with major organizations, including a handful of sports franchises, such as the Golden State Warriors and the Pac-12 Conference, to help aid in concussion identification and rehabilitation. Earlier this year, it entered the world of athletic cognitive training as part of a new partnership with mixed-reality headset maker Magic Leap.