The US Food and Drug Administration (FDA) has granted breakthrough designation for SyncThink's Eye-Sync technology, a virtual reality eye-tracking platform that provides objective measurements to aid in the assessment of concussion, the company has announced.
Eye-Sync is currently used to assist clinicians in evaluating visual impairments, monitor recovery and support the rehabilitation of ocular-motor and ocular-vestibular deficits, and optimize brain performance, according to the company.
The platform consists of a virtual reality headset with infrared cameras that connect wirelessly to a tablet where results can be viewed within 60 seconds.
The FDA initially cleared the Eye-Sync platform in March 2016 for recording, viewing, and analyzing eye movements to help clinicians identify visual tracking impairment.
Since approval, SyncThink has been working with various organizations including the Golden State Warriors, the Pac-12 Conference, Massachusetts General Hospital, and Stanford Children's Hospital, according to the company.
The company said it now has 40 user locations in North America, as well as more than 200 clinicians using Eye-Sync. During 2018, the technology was used for nearly 30,000 baseline assessments, over 2000 discrete injury assessments, and over 5900 postinjury assessments. SyncThink maintains the world's largest eye-tracking database, with over 50,000 patient results, the company said.
The breakthrough designation from the FDA means the technology has the potential to solve an unmet need for providing objective measurements to aid in the assessment of concussion.
"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, chief executive officer of SyncThink, said in a news release.
Cite this: Eye-Tracking Technology for Concussion Gets FDA Thumbs Up - Medscape - Mar 05, 2019.