FDA has granted a breakthrough device designation to SyncThink's Eye-Sync technology. The objective eye-tracking platform is currently used to assist clinicians in evaluating visual impairments, monitor recovery and support the rehabilitation of ocular-motor and ocular-vestibular deficits, and in the optimization of brain performance.
The breakthrough device designation recognizes the technology's potential to provide objective measurements to aid in the assessment of concussion.
FDA's breakthrough devices program is intended for products that provide more effective treatment or diagnosis of conditions and the program was created as an effort to provide patients and healthcare providers with timely access to medical devices. The program works to shorten the timeframe within which medical devices are approved.
“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
FDA initially cleared the Eye-Sync platform in March 2016 for recording, viewing, and analyzing eye movements to help clinicians identify visual tracking impairment. The platform is a modified virtual reality headset with infrared cameras that connect wirelessly to a tablet where results are viewable to the clinician within 60 seconds. The platform includes Eye-Sync Smooth Pursuit, Eye-Sync VOR, and Eye-Synch Saccade based assessments.