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FDA approves first ever non-invasive and baseline-free concussion testing tool

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The EyeBOX device analyzes eye movement to determine if someone has suffered a concussion.

WFA National Championship - Boston Militia v San Diego Surge
FILE PHOTO - A doctor administers a common concussion test on the sidelines of a WFA National Championship game.

This month, per MD Magazine, it was revealed that the US Food and Drug Administration (FDA) approved EyeBOX; a non-invasive and baseline-free tool that has been developed to diagnose concussions through the tracking eye movement.

The tool, which resembles the kind of equipment popular in eye-testing clinics, requires a patient to place their chin on a resting plate and look into a camera for around four minutes. The machine, according to Oculogica (EyeBOX’s creators), uses a unique algorithm to analyze 100,000 data points to determine whether or not the patient has suffered a concussion.

Oculogica co-founder Dr. Uzma Samadani explained how eye-tracking can be used as a diagnostic tool for concussions in a 2015 TED Talk.

Currently, the most widely used method of testing for concussions is having a physician ask questions to a patient while observing their behavior. The information gathered by the physician is compared to results of baseline testing that would have been done beforehand.

EyeBOX doesn’t require any baseline testing. Because of this, the tool is considered a potential game-changer in emergency rooms, which often deal with trauma victims who are unable to provide any baseline testing.

The device could also be revolutionary in sports and military settings, where patients have been known to ‘game’ the system by memorizing their baseline tests in order to pass their concussion protocols.

Robert Spinner, MD, chair of the Department of Neurological surgery at Mayo Clinic, stated that this technology will result in, “more consistent and objective diagnoses of concussion in the emergency room and clinic, and eventually on the field.”

Before getting FDA approval EyeBOX underwent a trial involving 282 patients at six independent clinical sites in the US. The results of that trial showed that EyeBOX demonstrated a high sensitivity to the presence of concussion. The study also showed that EyeBOX was consistent in providing negative results for individuals who had not suffered a concussion.

Concussions, traumatic brain injuries (TBIs), and repeated sub-concussive blows to the head, have all been shown to lead to chronic traumatic encephalopathy (CTE); a condition that has affected a large number of athletes who played in the NFL, NHL, and other sports. MMA’s first confirmed case of CTE was discovered in Jordan Parsons, a Bellator veteran, who was struck and killed by a drunk driver in 2016.

EyeBOX joins Infrascanner (a non-invasive scanner that measures blood flow in the brain and can detect TBIs) as tools which could be used to rapidly diagnose head injuries in combat sports athletes.

Since its release, the Infrascanner has found its way into MMA. The Californa State Athletic Commissioner owns two devices and has them available for all boxing and MMA events in the state. The device has also been used for Bellator and BAMMA events in Ireland. The now defunct MMA team known as the Blackzilians also had an Infrascanner on their premises.