EyeBOX is now cleared for acute concussion diagnosis and monitoring concussion recovery over time

By Malayka Gormally. This article was initially published in the 6/18/25 edition of our Concussion Update newsletter; please consider subscribing.

Having first achieved FDA approval in 2019, Oculogica’s EyeBOX remains the “only FDA-cleared and Health Canada registered diagnostic aid for concussion that does not require a pre-injury baseline test.” The EyeBOX provides a video for the patient to watch, and the device tracks eye movements, collecting data based on cranial nerve function. Oculogica has recently reported several exciting new developments for the EyeBOX: a new FDA label, a published study by Christina L. Master et al. at Children’s Hospital of Philadelphia, and the inclusion of the EyeBOX in the TRANSCENDENT Concussion Research program in Canada. 

The FDA originally cleared the EyeBOX as an aid in diagnosing acute concussions. However, the new FDA label allows providers to use the EyeBOX to monitor a patient’s recovery over time by comparing the patient’s recovery to normative data. Oculagica suggests that this new use will allow providers to “Make clearer, more confident return-to activity decisions supported by normative comparisons,” and “Have greater support for your treatment recommendations.” (Note: Concussion Alliance has no financial relationship with Oculogica.)

A study by Christina L. Master et al. compared the EyeBox with the results of visio–vestibular examination (VVE) and tandem gait assessment. The authors of the study, published in the Journal of Sport and Health Science, found that the EyeBOX can aid in the identification of concussion-related vision disorders in adolescents with persisting post-concussive symptoms. An Oculogica Publications Key-Takeaways summary of the study points out that while early “detection of concussion-related vision dysfunction,” improves outcomes, a specialist with assessment skills may not be available, making the EyeBOX a good option.

The TRANSCENDENT Concussion Research Program in Canada announced that they will be using the EyeBOX in their research studies. Lead researcher Dr. Roger Zemek explains.“‘We are proud to have the unique opportunity to use the EyeBOX as part of our comprehensive TRANSCENDENT Concussion Research Program. This tool provides a rapid, objective assessment of subtle eye movements, and we are excited to explore its potential to enhance clinicians’ ability to identify and differentiate concussions.”