The Food and Drug Administration (FDA) has granted Breakthrough Designation for SyncThink’s Eye-Sync technology, a virtual reality (VR) eye-tracking platform to assist in diagnosing concussions. 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 established as an effort to provide patients and health care providers with timely access to medical devices by shortening the time frame within which medical devices are approved while adhering to safety and efficacy standards. The designation enables SyncThink to facilitate broader applications of use for the Eye-Sync platform.
“With millions of concussions occurring each year the need for 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, chief executive officer of SyncThink.
Eye-Sync originally gained FDA clearance in March 2016 for recording, viewing and analyzing eye movements to help identify visual impairments, monitor recovery and support the rehabilitation of ocular-motor and ocular-vestibular deficits, and optimize brain performance.
Since then, the company has been working with organizations including the Golden State Warriors, the Pac-12 Conference, Mass General Hospital, Stanford Children’s Hospital and Children’s National to test the device for identifying concussions. Eye-Sync was used for more than 30,000 baseline assessments, 2,000 discrete injury assessments, and more than 5,900 post-injury assessments.
Eye-Sync consists of a modified VR headset with infrared cameras that connect wirelessly to a tablet where results are viewable within 60 seconds. Abnormal patterns can be detected that are indicative of a particular visual impairment in need of targeted treatment, such as that for concussion.
Only in recent years have medical experts begun to understand the severity and long-term effects of concussions. They are particularly concerned about athletes, who often sustain repeated concussion while on the playing field, from the youngest all the way up to professional sports. Traumatic Brain Injury also is the signature injury for U.S. veterans of the most recent wars in Iraq and Afghanistan.
Concussions are actually traumatic brain injuries (TBIs), although the most mild form. The symptoms for mild TBIs usually resolve in days to weeks. However, all brain injuries are serious injuries and can have long-term effects on survivors.
Beasley Allen attorneys have worked with a number of clients who experienced TBIs. Three of the firm’s lawyers are actively involved in the state’s leading brain-injury nonprofit organization, the Alabama Head Injury Foundation. Mike Andrews is the President of AHIF’s Board of Directors, while Stephanie Monplaisir is Montgomery Chapter President and Evan Allen serves on the AHIF’s Junior Board Chapter.