Regulatory Statement of Proposed Intended Use
SynchronyGamma Neuro (SynG Neuro) is a music and light-based tool intended for use by health care professionals as part of their independent clinical practice and professional judgment. The system enables clinicians to configure and deliver structured audiovisual sensory sessions by synchronizing user-selected or clinician-curated music with coordinated visual light patterns presented through compatible augmented reality displays.
SynG Neuro provides functionality to initiate, time, and manage sessions; adjust audiovisual parameters; and supports routine use through basic session controls and optional reminders. The software also allows clinicians to review session information and user-entered data, such as session completion or subjective reflections, for the purpose of supporting engagement and adherence.
SynG Neuro does not analyze physiological data, perform patient-specific clinical assessments, generate diagnostic or prognostic outputs, or provide automated treatment recommendations.
Any therapeutic use of SynG Neuro is determined solely by the treating health care professional under the practice of medicine, consistent with applicable training, licensure, and responsibility for patient care. SynG Neuro does not diagnose, treat, cure, prevent, or mitigate disease, and does not direct or replace clinical decision-making. Rather, it functions as a configurable, low-risk tool that clinicians may incorporate into broader care plans at their discretion, with all medical judgments and patient management remaining the responsibility of the health care professional.
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