The US Food and Drug Administration (FDA) has cleared SyncThink’s Eye-Sync technology to aid in the diagnosis of mild traumatic brain injury, the company has announced.
Eye-Sync is a virtual reality eye-tracking platform that provides objective measurements to aid in the assessment of concussion. It’s the first mobile, rapid test for concussion that has been cleared by the FDA, the company said.
As reported by Medscape Medical News, Eye-Sync received breakthrough designation from the FDA for this indication in March 2019.
The FDA initially cleared the Eye-Sync platform for recording, viewing, and analyzing eye movements to help clinicians identify visual tracking impairment.
The Eye-Sync technology uses a series of 60-second eye tracking assessments, neurocognitive batteries, symptom inventories, and standardized patient inventories to identify the type and severity of impairment after concussion.
“The platform generates customizable and interpretive reports that support clinical decision making, and offers visual and vestibular therapies to remedy deficits and monitor improvement over time,” the company said.
In support of the application for use in concussion, SyncThink enrolled 1655 children and adults into a clinical study that collected comprehensive patient and concussion-related data for over 12 months.
The company used these data to develop proprietary algorithms and deep learning models to identify a positive or negative indication of concussion.
The study showed that Eye-Sinc had sensitivity greater than 82% and specificity greater than 93%, “thereby providing clinicians with significant and actionable data when evaluating individuals with concussion,” the company said in a news release.
“The outcome of this study very clearly shows the effectiveness of our technology at detecting concussion, and definitively demonstrates the clinical utility of Eye-Sinc,” SyncThink Chief Clinical Officer Scott Anderson said in the release.
“It also shows that the future of concussion diagnosis is no longer purely symptom-based, but that of a technology driven multi-modal approach,” Anderson said.