---
title: "Psych News Alert: FDA Approves Marketing of Eye-Tracking Test for Detecting Concussion"
description: The Food and Drug Administration has cleared  for marketing an eye-tracking test that can help determine whether a patient has experience...
image: https://alert.psychnews.org/hubfs/Imported_Blog_Media/eye_iStock-866612478-Jun-24-2025-04-27-16-5022-PM.jpg
---

 1/9/19 12:00 AM

# FDA Approves Marketing of Eye-Tracking Test for Detecting Concussion

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The Food and Drug Administration has [cleared](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?ID=DEN170091) for marketing an eye-tracking test that can help determine whether a patient has experienced a concussion.

The device, known as EyeBOX, uses a camera to measure a patient’s eye movements in response to a stimulus. Such information can help physicians and other health care professionals better assess the extent of a patient’s brain injury.

“Other diagnostics require a baseline test, typically generated at the beginning of a sport season, pre-injury, [which] is compared to subsequent test results at the time of a suspected concussion. In many situations, a baseline concussion assessment is not feasible, especially when evaluating trauma patients in the emergency room,” according to a [press statement](http://www.oculogica.com/oculogica-receives-fda-marketing-authorization-for-eyebox-the-first-non-invasive-baseline-free-test-for-concussion) by Oculogica, the manufacturer of the device. “EyeBOX’s unique eye-tracking algorithm enables it to be baseline-free, a major advancement for the field.”

The FDA’s decision to approve the test for marketing was based in part on the results of a trial of 282 patients who presented with a suspected head injury to the emergency departments and sports medicine clinics at six independent clinical sites. The researchers compared the results of the EyeBOX test with those of a clinical reference standard for concussion. According to Oculogica, “The study showed that the EyeBOX had high sensitivity to the presence of concussion and that a negative EyeBOX result is consistent with a lack of concussion, thus providing objective data for health care providers to aid in the evaluation of patients with suspected TBI.”

EyeBOX is intended for patients aged 5 to 67 years, according to Oculogica.

For related information, see the* Psychiatric News* article “[FDA Clears the Way for First Blood Test to Evaluate Head Injuries](https://psychnews.psychiatryonline.org/doi/10.1176/appi.pn.2018.3b15)” and the* Journal of Neuropsychiatry and Clinical Neurosciences* article “[Saccadic Impairment Associated With Remote History of Mild Traumatic Brain Injury](https://neuro.psychiatryonline.org/doi/full/10.1176/appi.neuropsych.15100243).”

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[FDA](https://alert.psychnews.org/tag/fda), [concussion](https://alert.psychnews.org/tag/concussion), [brain injury](https://alert.psychnews.org/tag/brain-injury), [eye-tracking test](https://alert.psychnews.org/tag/eye-tracking-test), [marketing](https://alert.psychnews.org/tag/marketing), [EyeBOX](https://alert.psychnews.org/tag/eyebox), [Oculogica](https://alert.psychnews.org/tag/oculogica)

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## [FDA Approves First Blood Test to Detect Concussions](https://alert.psychnews.org/2018/02/fda-approves-first-blood-test-to-detect.html)

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