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FDA Grants De Novo Clearance for Concussion Diagnostic Aid

January 8, 2019

The Food and Drug Administration (FDA) has granted a de novo marketing authorization for the EyeBOX (Oculogica Inc.), a device that measures eye movements to assess brain function.

EyeBOX is classified by the FDA as “a traumatic brain injury eye movement assessment aid…that uses a patient’s tracked eye movements to provide an interpretation of the functional condition of the patient’s brain. This device is an assessment aid that is not intended for standalone detection or diagnostic purposes.”

The device has a screen that displays a stimulus for the patient’s eyes to follow; an eye tracking camera measures the eye movements for the duration of the exam. A computer applies an analysis algorithm to the tracked eye movements and performs an analysis of a patient’s tracked eye movements to assess their functional brain injury status. The device may be a stand-alone device or implemented as a software app on a smartphone/tablet.

The de novo application to the FDA was supported by results from the pivotal DETECT clinical study of 282 patients who presented in the emergency room and concussion clinic with suspected traumatic brain injury. The manufacturer plans to market the device for use in patients aged 5 to 67 years, starting with a pilot launch for select, qualified sites.


Food and Drug Administration (FDA). De novo classification DEN170091. Available at: click here. Accessed January 7, 2019.