Brain-Health Platform Gets An FDA Nod Of Approval

SyncThink’s EYE-SYNC, the established objective eye-tracking platform used in evaluating visual impairments, monitoring recovery and supporting rehabilitation of ocular-motor and ocular-vestibular deficits, and optimizing brain performance, is the recipient of Breakthrough Device Designation from the Food and Drug Administration. The designation recognizes that SyncThink’s EYE-SYNC technology has the potential to satisfy the need for providing objective measurements to aid in the assessment of concussion.



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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.


The EYE-SYNC platform is a modified virtual reality (VR) 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-SYNC Saccade based assessments. Through these assessments, abnormal patterns can be detected that are indicative of a visual impairment in need of targeted treatment intervention.


Learn more about the FDA program with a visit to the Breakthrough Devices Program and get a better handle on the EYE-SYNC platform by watching the video below and with a visit to the EYE-SYNC page.



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