FDA Grants Breakthrough Device Designation to Concussion Assessment Device

Source: SyncThink

SyncThink announced that the FDA has granted Breakthrough Device Designation to EYE-SYNC, an objective eye-tracking platform. The EYE-SYNC platform is 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. This designation recognizes that SyncThink’s EYE-SYNC technology has the potential to solve an important unmet need for providing objective measurements to aid in the assessment of concussion.

The Breakthrough Devices Program of the FDA is for medical devices and products that provide more effective treatment or diagnosis of life-threatening conditions and was founded as an effort to provide patients and health care providers with timely access to medical devices. The program works to shorten the timeframe within which medical devices, such as EYE-SYNC, are approved while adhering to the utmost standard to promote public health. It also only admits devices that provide for more effective treatment or diagnosis of life-threatening or debilitating conditions. This new designation from the FDA helps SyncThink to facilitate broader applications for use for the EYE-SYNC platform and continued improvement for use for the public.

“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,” Laura Yecies, CEO of SyncThink, said in a company news release.

The EYE-SYNC platform gained initial FDA clearance in March of 2016 for recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects. Since then, SyncThink has begun working with top organizations like the Golden State Warriors, the Pac-12 Conference, Mass General Hospital, Stanford Children’s Hospital, Children’s National and others. Also, prominent sports figures such as Steve Young, Taylor Twellman, and Coby Fleener have joined the advisory board of SyncThink.

Developed over 15 years of clinical research and with 13 issued patents, the EYE-SYNC platform is a modified VR headset with infrared cameras that connect wirelessly and securely to a tablet where results are viewable to the clinician within 60 seconds. The comprehensive brain health platform includes EYE-SYNC Smooth Pursuit, EYE-SYNC VOR, and EYE-SYNC Saccade based assessments. Through these assessments and based on extensive peer-reviewed research, abnormal patterns can be detected that are indicative of a particular visual impairment in need of targeted treatment intervention.


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