Concussion is a challenging condition, and SyncThink has created its EYE-SYNC platform, which is now approved by FDA, to Detect and find Appropriate treatment for Concussion.
FREMONT, CA: “After a decade of clinical research, 30 publications, and 16 patents, we are pleased to formally extend EYE-SYNCs indications to the many providers who will benefit from rapid, objective diagnostic technology,” states SyncThink Founder and Stanford University Professor Jam Ghajar, MD, PhD. The US Food and Drug Administration (FDA) has awarded clearance of the EYE-SYNC technology as an Aid to Concussion, or mild Traumatic Brain Injury (mTBI) Diagnosis, to SyncThink, a next-generation neurotechnology firm and developer of the award-winning EYE-SYNC technology. Following the initial clearance and commercialization of the technological platform in 2017, EYE-SYNC was awarded the prestigious Breakthrough Device Designation by the FDA in 2019.
To determine the type and severity of dysfunction following a concussion, the EYE-SYNC technology employs a series of 60-second eye-tracking evaluations, neurocognitive batteries, symptom inventories, and standardized patient inventories. The platform creates configurable and explanatory reports to aid clinical decision-making, as well as visual and vestibular therapies to correct deficiencies and track progress over time.
“Concussion is a complex condition and a challenge for many clinicians to manage, so we hope that by offering highly accurate diagnostic tools and proven algorithms, we will help providers and their patients identify the most effective and appropriate treatment,” adds Ghajar.
SyncThink conducted clinical research for this application that lasted over a year and collected thorough patient and concussion-related data. SyncThink used this data to develop proprietary algorithms and deep learning models to determine whether concussions are positive or negative. The study found that EYE-SYNC had a sensitivity of more than 82 percent and a specificity of more than 93 percent, giving clinicians helpful information to use when evaluating concussion patients.
“The outcome of this study very clearly shows the effectiveness of our technology at detecting concussion, and definitively demonstrates the clinical utility of EYE-SYNC. It also shows that the future of concussion diagnosis is no longer purely symptom based, but that of a technology driven multi-modal approach,” comments SyncThink Chief Clinical Officer Scott Anderson.