EYE-SYNC
SyncThink, Inc.EYE-SYNC is a portable eye-tracking device that helps medical professionals diagnose concussions by recording and analyzing eye movements. It includes a head-mounted eye tracker, a display, and a tablet app that together monitor eye motion patterns to detect impairments linked to mild traumatic brain injury in sports-related head injuries. This assists healthcare providers in making timely and accurate concussion assessments.
Intended Use
The EYE-SYNC is intended for recording, viewing, and analyzing eye movements to aid in diagnosing concussion (mild traumatic brain injury) within three days of sport-related head injury in patients aged 17-24, used alongside standard neurological assessment by qualified medical professionals.
Technology
The device is a fully enclosed portable eye-tracking system consisting of a modified Samsung GearVR headset with infrared cameras to track eye gaze, a display device running a software app for data collection and calibration, and an Android tablet for data management, Bluetooth control, assessment paradigms including smooth pursuit and VOR, and cloud synchronization.
Performance
The device underwent electrical safety and EMC testing to IEC standards, software verification and validation per FDA guidance, biocompatibility testing, non-sterile provision, and clinical testing involving 1,069 subjects showing 82% sensitivity and 93% specificity in concussion detection within 3 days post-injury, supporting substantial equivalence to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/29/2020
1 year - 2
FDA Approval
10/2/2021
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