Clinical & Regulatory

This page summarises Aescia’s intended use and regulatory posture for evaluation contexts.

Intended use

Aescia supports post-discharge monitoring and escalation workflows by collecting structured patient-reported information and presenting it for clinical review.

Not intended for

Aescia is not intended to:

• provide autonomous diagnosis
• provide autonomous treatment decisions
• replace clinical judgement
• be used as the sole basis for escalation or non-escalation decisions
• be used for emergency triage

Clinician-in-the-loop model

Aescia outputs are reviewed by clinicians or delegated clinical staff according to local governance. The hospital retains responsibility for clinical decisions and escalation actions.

Software as a Medical Device positioning

Aescia is positioned as Software as a Medical Device (SaMD) for regulatory purposes. Evaluation use is limited to approved clinical evaluation contexts and does not imply regulatory clearance for routine clinical deployment.

Evaluation-only status

Any evaluation is subject to:

• local governance approvals
• privacy and security review
• ethics approval where applicable
• a defined evaluation protocol and scope limitations