The U.S. Food and Drug Administration (FDA) has granted EYE-SYNC, an award-winning VR eye-tracking platform from a leading neurotechnology company SyncThink, Breakthrough Device Designation. Currently, clinicians use EYE-SYNC to evaluate visual impairments, monitor recovery and support the rehabilitation of ocular-motor and ocular-vestibular deficits, and to optimize brain performance. The Breakthrough Device designation from the FDA shows that EYE-SYNC technology has the potential to solve an important unmet need for providing objective measurements to aid in the assessment of concussion.
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The FDA’s “Breakthrough Devices Program” is for medical devices and products that provide more effective treatment or diagnosis of life-threatening conditions. It was founded as an effort to provide patients and health care providers with timely access to medical devices.
“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.
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The FDA granted initial clearance to EYE-SYNC in March 2016 for recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in humans. Since then, SyncThink has been working with top organizations like the Golden State Warriors, the Pac-12 Conference, Massachusetts 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, reports SyncThink.
EYE-SYNC, a modified VR headset, was developed after 15 years of clinical research and with 13 issued patents. The device has 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.
