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    NEUROSYNC, INC.

    FDA registration
    NEUROSYNC, INC.·2 products·🇺🇸 United States

    EYE-SYNC

    FDA UDI
    NEUROSYNC INC.·00868096000300·

    EYE-SYNC

    FDA UDI
    NEUROSYNC INC.·00860013612900·The NeuroSync EYE-SYNC device is a portable, fu...

    NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded sensors, a paired Android tablet, and proprietary software, packaged in a portable field case. Eye-tracking headset system is intended for recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects. The EYE-SYNC is intended to record, measure, and analyze eye movements as an aid in the diagnosis of concussion, also known as mild traumatic brain injury (mTBI).

    FDA Recall
    Open, Classified ·NeuroSync, Inc.·Product code QEA·September 19, 2023

    NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded sensors, a paired Android tablet, and proprietary software, packaged in a portable field case. Eye-tracking headset system is intended for recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects. The EYE-SYNC is intended to record, measure, and analyze eye movements as an aid in the diagnosis of concussion, also known as mild traumatic brain injury (mTBI).

    FDA Enforcement
    Class II ·Ongoing·NeuroSync, Inc.·July 23, 2025