EyeBOX
Oculogica, Inc.EyeBOX is an eye-tracking device designed to help diagnose concussion by measuring and analyzing eye movements in patients within one week of a head injury. It uses near-infrared cameras to track gaze positions and an AI-driven algorithm to detect subtle changes in eye movements associated with concussion, aiding clinicians in neurological assessment.
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 device incorporates a host PC with a touchscreen interface, an eye tracking camera using a high-speed near-infrared sensor recording gaze positions at 500 Hz, an LCD stimulus screen, and a head-stabilizing rest. A data processing algorithm analyzes recorded eye movements to detect subtle changes indicative of concussion.
Performance
Performance testing included safety testing per ANSI/AAMI ES60601-1, electromagnetic emissions and immunity testing per IEC 60601-1-2, hardware verification, and software validation demonstrating equivalence in function to the predicate device.
Predicate Devices
No predicate devices specified
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