FDA Approves Marketing of Eye-Tracking Test for Detecting Concussion
Psychiatric News Alert|
The Food and Drug Administration has cleared 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 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.