An eye-tracking test for concussion that requires no baseline assessment is cleared for U.S. marketing, said neurodiagnostics company Oculogica.
To be sold as EyeBOX, the 4-minute, non-invasive test is approved for use in patients ages 5 to 67. Oculogica said it’s the first such test to win FDA marketing authorization. Patients watch a short video with their heads placed in a chin-and-forehead rest similar to those commonly used in optometry clinics. Eye movements are analyzed with a proprietary algorithm.
Initial distribution will be limited to “select, qualified sites,” the firm said.
Approval (via the FDA’s “de novo” authorization pathway for novel, low- to moderate-risk devices) was based primarily on a 282-patient clinical study involving children and adults presenting to emergency departments and concussion clinics with head injuries. Patients were evaluated within 2 weeks of injury. Full results have not yet been published.
One journal paper involving another Oculogica study indicated that, in children with suspected concussion, the test achieved 72% sensitivity with 84% specificity when patients were evaluated an average of 22 weeks after injury.