FDA Grants SyncThink’s EYE-SYNC Platform Breakthrough Device Designation for Aid to Concussion Assessment
Palo Alto, CA—February 19, 2019—SyncThink, a world leader in neurotechnology and brain health analytics, announces today its award-winning technology, EYE-SYNC is the recipient of Breakthrough Device Designation from the Food and Drug Administration. 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. 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” said Laura Yecies, CEO of SyncThink
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.
SyncThink remains dedicated to developing technology to allow everyone from athletes to patients to objectively monitor and improve their brain health and performance.
About SyncThink: SyncThink is on a mission to provide objective measurements for brain health and empower people to maximize their health and performance. SyncThink develops revolutionary eye-tracking technology and analytics, in a VR environment, that assist medical professionals in assessing brain health, monitoring recovery and optimizing performance. With more than 30 published peer-reviewed papers and 13 granted patents, the SyncThink platform uses a series of 60-second assessments to objectively measure eye movements to identify impairments and offers multiple modalities to train dynamic vision. FDA-cleared for detecting eye-tracking impairment and used by leading medical centers such as Stanford and Massachusetts General, the U.S. military, and more than 20 top universities, SyncThink is transforming assessment, recovery, and performance for life and sport. www.syncthink.com
About the Breakthrough Devices Program
The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. To learn more, visit the FDA page Here.