About Sympnotic-AI (Regulatory Description)

Developed by: Realigns Pharmaceuticals.,Co.Ltd Thailand.

Product Category

Clinical Decision Support Software (CDS)

Intended Users

Licensed physicians, medical officers, and qualified clinical practitioners

Intended Use Environment

Hospitals, clinics, outpatient settings

Intended Use Statement

Sympnotic-AI is a clinical decision support software intended to assist licensed healthcare professionals by providing data-driven clinical reference, structured case discussion, and guideline-based alerts derived exclusively from manufacturer-validated medical datasets.

Sympnotic-AI does not provide autonomous diagnoses, treatment decisions, or prescriptive medical advice. Final clinical judgment and responsibility remain entirely with the healthcare professional.

Product Description

Sympnotic-AI is designed as a non-authoritative clinical co-pilot that supports clinicians during patient evaluation through structured, stepwise interaction. The system facilitates:

Guided history-taking
Symptom correlation
Highlighting of dataset-defined red-flag conditions
Interpretation assistance for laboratory values
Contextual explanation of medical concepts

All clinical content presented by the system is derived solely from internally maintained, validated medical datasets owned and controlled by Realigns Pharmaceuticals.,Co. Ltd Thailand.

Data Governance and Clinical Integrity

Deterministic Clinical Data (System of Record)

  • All medical logic, thresholds, red-flag criteria, and disease associations are stored in structured, deterministic datasets (e.g., JSON-based clinical logic files).
  • These datasets constitute the sole authoritative source for all clinical content.
  • No external internet data, crowd-sourced content, or model-generated medical facts are used for clinical reasoning.

Probabilistic Language Processing (System of Reasoning)

A large language model (LLM) is used only for:

  • Conversational flow & clarification of clinician input
  • Multi-turn dialogue management & Language translation

The LLM is structurally prohibited from:

  • Introducing new clinical facts or generating diagnoses.
  • Modifying or extending dataset-defined medical logic.

Functional Capabilities

Guided Clinical Discussion

Conducts stepwise, case-based dialogue aligned with clinical reasoning workflows. Follow-up questions are generated strictly based on dataset-defined symptom and disease relationships.

Red-Flag and Escalation Alerts

Identifies high-risk scenarios (“cannot-miss” conditions) exclusively when dataset-defined criteria are met. Alerts are informational and advisory, prompting clinician review rather than directing action.

Laboratory Result Review

Highlights abnormal results based on deterministic reference ranges contained within the datasets. No interpretation beyond dataset thresholds is generated.

Medical Image Contextual Assistance

When medical images are uploaded, the system may provide non-diagnostic contextual observations aligned with dataset references. Image analysis outputs are advisory only and require clinician confirmation.

Transparency and Auditability

  • Every clinical statement presented by Sympnotic-AI is traceable to a specific internal dataset entry.
  • Dataset references can be reviewed by the clinician.
  • Session context and dataset usage are logged to support audit, quality review, and regulatory inspection.

Risk Controls and Limitations

  • Sympnotic-AI cannot generate clinical conclusions outside certified datasets.
  • The software does not learn from user input in a way that alters clinical logic.
  • The system does not replace clinical training, judgment, or decision-making.
  • Use of the software does not reduce the clinician’s responsibility for patient care.

Regulatory Positioning

Sympnotic-AI is designed in alignment with FDA guidance on Clinical Decision Support Software, ensuring that:

  • The basis of recommendations is transparent.
  • Users can independently review the underlying rationale.
  • The software does not function as an autonomous medical decision-maker.