The Food and Drug Administration has granted a de novo request for marketing authorization of an algorithm-driven eye-movement tracking system (Eyebox; Oculogica, New York, NY) for the diagnosis of concussion in patients age 5 years and up. The eye-tracking system is the first non-invasive tool for concussion, or mild traumatic brain injury (mTBI) diagnosis that does not require having a previous baseline screen to make the diagnosis.
Very few people, even those who play sports at the collegiate or professional level, have baseline assessments for mTBI done. Even when such baseline assessments have been done, they are typically not available at the point of care when individuals are being assessed for mTBI.
As previously reported in Practical Neurology, the patient stabilizes their head on a chin strap to reduce head movements and watches a 4-minute video as software analyzes whether or not the patients’ eyes are moving together.
Approval was based on the pivotal DETECT study (NCT02776462) of 282 patients at 6 clinical sites who presented in the emergency room with suspected traumatic brain injury (TBI). Among 56 children with concussion who were compared with 83 controls without mTBI, the system had 71.9% sensitivity and 84.4% specificity.
“Looking beyond this milestone, EyeBOX has the potential to aid in the diagnosis of other neurological conditions and may benefit researchers developing therapies for TBI and concussion,” said John Leddy, MD, Medical Director of the University at Buffalo Concussion Management Clinic. “Development of treatments for concussion is challenging because there are few reliable outcome measures. EyeBOX may offer one solution to this challenge, providing researchers with an objective oculomotor assessment tool.”Next Story