EyeBOX
Oculogica, Inc.The EyeBOX is an eye-tracking device designed to assist clinicians in diagnosing concussion by analyzing eye movements. Patients watch a video on a screen while a near-infrared camera records their eye gaze data. The device processes this data using advanced algorithms to detect subtle abnormalities in eye movement that indicate concussion, helping doctors make timely and accurate assessments.
Intended Use
The EyeBOX is intended to measure and analyze eye movements as an aid in the diagnosis of concussion, also known as mild traumatic brain injury (mTBI), within one week of head injury in patients 5 through 67 years of age in conjunction with a standard neurological assessment of concussion.
Technology
The EyeBOX system consists of a host PC with integrated touchscreen, an eye-tracking camera (high-speed near-infrared camera recording gaze positions at 500 Hz), an LCD stimulus screen, and a head stabilizer. It captures eye movements while the patient watches a moving video stimulus, and employs a proprietary data processing algorithm to detect subtle changes in eye movement patterns associated with concussion and produces a BOX score.
Performance
Comprehensive testing including electromagnetic emissions/immunity testing, light hazard protection testing, bench testing on an artificial eye to verify spatial precision and step response of the new camera, testing on 84 human participants to confirm accurate blink and gaze position detection, software verification, and user testing was performed demonstrating no adverse impact on performance due to technological changes.
Predicate Devices
No predicate devices specified
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