Governance

Aescia's regulatory posture.

Aescia runs two products with different regulatory postures. The Hospitals product is an investigational medical device with an intended Class IIa classification; a regulatory application has not yet been lodged. The Clinics product is a workflow tool that is not a medical device and is not represented as one. This page states what each is, and what each is not.

Aescia for Hospitals

Investigational medical device on the regulatory pathway.

Classification: Software as a Medical Device (SaMD), intended Class IIa. Application not yet lodged.
Regulatory roadmap: Under development. No TGA, MDSAP, FDA, CE/UKCA, or Health Canada applications have been filed.
Certification: Aescia is not certified to ISO 13485, ISO/IEC 27001 or IEC 62304, standards of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). Certification is planned.
Clinical evaluation: Through the SAFE-Discharge trial (ACTRN12625001425482).
Current engagement: Evaluation and pilot contracts only, not commercial supply.
Output posture: Advisory only. The clinician remains the decision-maker.

Aescia for Clinics

A workflow tool. Not a medical device.

Classification: Software as a Service. Not a medical device, not represented as one.
Boundary: Does not diagnose, does not treat, does not propose clinical decisions.
Posture: Propose, do not decide. The clinician remains in control.
Rule content: Delivers clinician-authored educational content and prep instructions.
Escalation: Routes exceptions to named staff, does not act autonomously.
Engagement: Design-partner program: free during the proof period, then per-scope pricing once the platform proves the return on the clinic's own data.

Neither product has been certified or independently assessed for conformity. Certification is planned. A full security pack is available to prospective customers under a mutual non-disclosure agreement (NDA).

Security and data

A documented posture available to buyers under NDA.

Data and software

Hosting providers encrypt data in transit and at rest
Trial data stored in Australia (Amazon Web Services Sydney region, through Supabase)
Documented sub-processor list on request
Minimum-necessary collection by design
Open Worldwide Application Security Project (OWASP) secure development baseline

Integration

One prioritised list for the team, not a new portal
Clinician-authored rules and routing
Quick to set up; any data exchange scoped per site

Clinical oversight

Clinician-authored pathways and rules
Advisory output, clinician decides
Escalation policies configurable per institution

Regulatory

Intended Class IIa for Hospitals, application not yet lodged
Non-device posture for Clinics, documented per feature
Patient-facing alerts on clinician-authored, explainable rules; ML used only for advisory back-end analysis

Corporate

Structured for multi-region operation.

R&D entity: 9550-0708 Québec inc. Holds the platform intellectual property and carries out the research and development. NEQ 1181312316.
Regulatory applicant: Aescia Pty Ltd, which operates in Australia and New Zealand. ABN 96 687 840 517.
Resident director: Shannon Kurrle, Aescia Pty Ltd. Statutory requirement under the Australian Corporations Act.
Registered office: Sydney, Australia.
Operations: Montréal, Canada. Sydney, Australia.

For where trial data is stored, the hosting providers' certifications and insurance, see the security page.

Open the security page