EyeBOX Test Gets FDA OK to Aid in Concussion Diagnosis

The Food and Drug Administration (FDA) has granted marketing authorization for EyeBOX (Oculogica), a non-invasive, baseline-free test which aids in the diagnosis of concussion in patients 5 to 67 years of age.

By using an eye-tracking algorithm, the device is able to provide clinicians with objective information to aid in the diagnosis of concussion; no pre-test calibration or baseline test is needed. The 4-minute test requires patients to place their head on a chin and forehead rest and watch a video. A binocular camera then tracks each eye and gathers data that ultimately leads to a score that rates the severity of brain injury; a score ≥10 is Oculogica’s threshold for concussion. 

The FDA approval was supported by results from the DETECT clinical study which included 282 patients with suspected traumatic brain injury. Results showed that compared with a clinical reference standard for concussion, EyeBox had high sensitivity to the presence of concussion; a negative result was consistent with a lack of concussion.

“Eye-tracking will change the practice of emergency care for concussion and will greatly assist a large number of patients,” said Dr Robert Spinner, Chair of the Department of Neurological surgery at Mayo Clinic. “The result will be more consistent and objective diagnoses of concussion in the emergency room and clinic, and eventually on the field.”

For more information visit oculogica.com.