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Objective Eye Tracking Tool for Concussion Granted FDA Approval


EyeBOX provides objective data for healthcare providers to aid in evaluating patients with possible brain injury.

eye, concussion, eye tracking, eye scan

Thumbnail has been resized. Courtesy of http://www.oculogica.com?rel=0" .

EyeBOX, a non-invasive, baseline-free tool created by Oculogica to aid in the diagnosis of concussion, has been granted marketing authorization by the U.S. Food and Drug Administration (FDA), according a release.

The device uses eye tracking to provide objective information via a 4-minute test that analyzes over 100,000 data points to aid clinicians in assessing patients with suspected concussion.

“Eye tracking will change the practice of emergency care for concussion and will greatly assist a large number of patients,” said Robert Spinner, M.D., 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.”

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Oculogica conducted the DETECT study to test EyeBOX, which included 282 patients at six independent clinical sites in the U.S. The study compared the EyeBOX results to a clinical reference standard for concussion in patients at emergency departments and sports medicine clinics with suspected head injury.

Based on the study, EyeBOX had high sensitivity to the presence of concussion and negative results were consistent with a lack of concussion. The results offer objective data for healthcare providers to aid in evaluating patients with possible brain injury.

Typical concussion diagnostics require a baseline test to be taken prior to the chance of concussion, compared to results at the time of the suspected brain injury. Baseline tests are not always practical though, especially when trauma patients show up in the emergency room.

According to the U.S. Center for Disease Control (CDC), more than 2.5 million emergency room visits in the U.S. are a result of head injuries. Traumatic brain injury is the leading cause of disability and the top cause of death for young adults. These injuries can cost the healthcare system at least $16.7 billion a year.

Treatments for concussions are challenging, according to John Leddy, M.D., medical director of the University of Buffalo Concussion Management Clinic. But he believes that EyeBOX could offer a solution by providing researchers with an objective oculomotor assessment tool.

And the six-person startup is not done yet.

Oculogica is conducting additional studies to assess applications in specific, new concussion therapies and in other neurological conditions of the brain.

Many companies are becoming increasingly interested in eye tracking, too.

Health-tech company IDx uses autonomous artificial intelligence (AI) to track diabetic retinopathy. Google acquired Eyefluence and employed eye experts to sharpen its disease-detecting AI and Apple acquired SensoMotoric Instruments GmbH to move into the space.

EyeBOX will be marketed for use for children and adults aged five to 67.

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