EYE-SYNC

The EYE-SYNC device serves as an objective aid for diagnosing sport-related concussion in young adults by employing a head-mounted eye tracker to record and analyze various eye movement paradigms such as smooth pursuit and saccades. Its methodology leverages proprietary pupil-corneal reaction tracking technology and visual synchronization metrics to identify visual tracking impairments indicative of mild traumatic brain injury, supported by clinical studies demonstrating its diagnostic sensitivity and specificity.

The EYE-SYNC device is a portable system designed for recording, viewing, and analyzing eye movements to identify visual tracking impairment. It comprises a head-mounted eye tracker, which is a modified virtual reality headset equipped with infrared cameras and LED illuminators, utilizing a proprietary pupil-corneal reaction method for gaze tracking. This is paired with an integrated eye tracking display and an Android tablet that manages control and data. The system employs several assessment paradigms, including Smooth Pursuit, Saccades, Vestibular-Ocular Reflex (VOR), and VOR Cancellation (VORx), managed by dedicated software on both the display device and the tablet. The tablet application supports patient management, assessment control, Bluetooth data transfer, analysis via visual synchronization metrics, report generation, and cloud connectivity for data synchronization. EYE-SYNC is intended as an adjunctive tool to aid medical professionals in diagnosing concussion, specifically mild traumatic brain injury (mTBI), in individuals aged 17-24 within three days of a sport-related head injury, when used in conjunction with a standard neurological assessment. Clinical validation involving 1,069 competitive athletes, where concussion prevalence was 10%, demonstrated the device's performance with 82% sensitivity and 93% specificity. It also achieved a negative predictive value of 98% and a positive predictive value of 56%. Test-retest reliability studies on key metrics such as SD tangential error (ICC 0.86), SD radial error (ICC 0.78), and mean phase error (ICC 0.83) indicated good consistency in its measurement capabilities.

AI Regulatory Concerns

Powered by

Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. How do the specific 'visual synchronization metrics' used for analysis quantitatively differentiate between concussed and non-concussed individuals, and what is the neurophysiological basis for these differences?; Given the 56% Positive Predictive Value at 10% prevalence, how does the device's utility change in populations with significantly different concussion prevalence rates, and what strategies could enhance its positive predictive value?; The device uses an eye tracking camera speed of 60 Hz. What specific performance and clinical testing validated that this sampling rate is sufficient for detecting subtle eye movement abnormalities relevant to concussion diagnosis compared to higher sampling rates?; Could the EYE-SYNC system be adapted or validated for use in non-sport-related mild traumatic brain injury, different age groups beyond 17-24 years, or for monitoring recovery progress beyond the initial 3-day post-injury window?; What are the specific parameters measured within the Smooth Pursuit, Saccades, Vestibular-Ocular Reflex (VOR), and VOR Cancellation (VORx) assessments, and how are these parameters weighted or combined by the device's algorithm to arrive at a concussion classification?