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Regulatory notice

HospitalsAescia for Hospitals is an investigational Software as a Medical Device under the TGA Class IIa pathway. Not yet available for commercial supply.

ClinicsAescia for Clinics is a workflow and patient-preparation tool. It does not propose clinical decisions and is not a medical device.

For Hospitals

The quietest days after surgery carry the loudest risk.

Aescia for Hospitals is a post-surgical recovery monitoring platform, built first for cardiothoracic surgery. Structured daily check-ins, clinician-authored prioritisation, one list for the nursing team. In clinical evaluation through the SAFE-Discharge trial at a major Australian cardiothoracic unit.

Status

In clinical evaluation through the SAFE-Discharge trial.

Aescia for Hospitals has an intended Class IIa classification under TGA Rule 3.4. A regulatory application has not yet been lodged. Engagement today is through evaluation and pilot contracts only. This page does not recruit trial participants.

Trial leadership

The Principal Investigator on SAFE-Discharge.

Aescia for Hospitals is in clinical evaluation through the SAFE-Discharge trial. The Principal Investigator is a practising cardiothoracic research clinician at the trial site. Further clinical advisors will be named on the site as each of them formally joins the advisory and consents to public acknowledgement.

Dr Kei Woldendorp

BMed MBBS MPhil, Cardiothoracic research

The Baird Institute, Royal Prince Alfred Hospital. Peer-reviewed publications in cardiothoracic care.

RolePrincipal Investigator, SAFE-Discharge trial. Clinical Advisor, Aescia for Hospitals.

The following describes the investigational intended use of Aescia for Hospitals, which is not yet TGA-registered and not available for commercial supply.

What we listen for after cardiothoracic surgery.

Pathways are authored by surgeons and nurses who live in this population. Each signal carries a named rule and a named escalation. The clinician remains the decision-maker.

01

Sternal wound

Mandatory baseline and weekly photographic review, prioritised against a structured change-over-time rule set authored with the operating surgeons.

02

Sternal dehiscence

Mechanical integrity signals distinct from infection. Cough, instability on movement, click-on-palpation prompts, routed direct to the operating team.

03

New-onset atrial fibrillation

Rate, rhythm, and symptom capture windowed against the common post-cardiac-surgery AF timeline. Anticoagulation status and last-dose surfaced on the card.

04

Heart failure decompensation

Daily weight, exertional symptom, and orthopnoea tracking against patient-specific thresholds set by the cardiology team.

05

Pleural and pericardial effusion

Breathlessness and positional symptom rules that prompt the team to re-image rather than react. Cross-referenced with recent imaging where integrated.

06

Bleeding

Anticoagulation-aware signals surfaced to the surgical team before the patient would otherwise call. Routing is to the registrar on take, not a generic inbox.

07

Stroke and new neurology

FAST-style self-report prompts, focal symptom flags, and a same-day in-person review pathway. Relevant after valve and aortic work where embolic risk is material.

08

Infection and systemic deterioration

Vitals, wound, and constitutional-symptom capture that surfaces to the team using the institution's own escalation policy.

Sternal wound protocol

Every wound, every week, time-stamped to the patient record.

Mandatory at discharge. Weekly thereafter. The patient is prompted, the image is stored against the patient record with time and device metadata, and the operating surgeon can see their own work at day 7, 14, and 30. The rule set looks for expanding erythema, dehiscence, sinus formation, and discharge change.

Day 0, 7, 14, 30
Minimum protocol cadence
Time-stamped
Stored against the patient record
Surgeon review
The operating team sees their own work

What a nurse sees on Monday morning.

Not a new portal, not an inbox. A list of named patients, ordered by rule-based urgency, each with the reason they surfaced, the last response, and a one-tap clinician action.

Discharge cohort · Mon 14 Apr42 active
  • Urgency level 5. Patient, P.
    Wound image flagged · Day 8
    6m
  • Urgency level 4. Patient, K.
    New palpitations · AF window
    22m
  • Urgency level 3. Patient, M.
    Weight gain > 1.5 kg over 48h
    1h
  • Urgency level 2. Patient, L.
    Mild breathlessness on stairs
    2h
  • Urgency level 1. Patient, S.
    Within expected recovery range
    3h
Illustrative previewLive view is configured to your escalation policy
How this fits your roster

Additive to the day, not additive to the headcount.

The worklist is owned by existing nursing roles, not a new role. After-hours routing is agreed with your on-call registrar and hospital switchboard before go-live. When a patient is readmitted to hospital, Aescia alerts for that patient mute automatically. The NUM sees who owns the list by shift, and can audit every routed alert.

01

Shift ownership

Named nursing role per shift, agreed with the NUM. Handover between shifts routes the list as part of the existing verbal handover.

02

After-hours routing

Higher-urgency signals route to the on-call surgical registrar after agreed hours. Configured per site, not a vendor default.

03

Automatic mute

When a patient is readmitted to hospital, Aescia alerts for that patient are suppressed until the team re-enables them. The system stops competing for attention while the patient is under inpatient care.

The cost of a false flag

Fewer alerts. Each one earned.

A post-discharge platform that flags everything is a platform no nurse will read. SAFE-Discharge includes alert burden as a pre-specified secondary outcome: the target is fewer than one nurse-actionable flag per patient per week over the 30-day post-discharge window, with documented review of every higher-urgency signal. We will report the number, whatever it is.

Target
< 1 flag per patient per week
Endpoint
Pre-specified in SAFE-Discharge
Active clinical programme

The SAFE-Discharge trial.

A prospective single-centre evaluation of Aescia for cardiothoracic post-discharge monitoring. A 50-patient interim cohort is pre-specified, followed by a 500-patient main cohort, 550 patients total. Registered with the Australian New Zealand Clinical Trials Registry. First participants expected following ethics and governance approval.

This page does not recruit trial participants. Enrolment is through the Royal Prince Alfred Hospital cardiothoracic unit under ethics approval.

Request the protocol summary
Registration
ACTRN12625001425482
Site
Royal Prince Alfred Hospital, Sydney
Unit
Cardiothoracic Surgery Unit
Patients
550 (50 interim + 500 main), single centre
Sponsor
Sydney Local Health District (SLHD)
Principal Investigator
Dr Kei Woldendorp, The Baird Institute
Status
Ethics approved. Site-specific governance in progress.

How health systems engage with us.

01

Scoped evaluation

Eight to twelve weeks, single service line, research-use framing, no commercial supply. Used to confirm the pathway fits your population and your escalation structure.

02

Supervised pilot

Six months, one to two service lines, conducted as research-use under site ethics approval. Agreed success metrics, data-sharing agreement, joint publication option. Not a commercial supply arrangement; product remains investigational throughout.

03

Enterprise deployment

Enterprise deployment is available only in jurisdictions where Aescia for Hospitals has received the applicable regulatory authorisation (ARTG inclusion in Australia, equivalent authorisations elsewhere). Not available for commercial supply prior to that authorisation.

It fits where your team already works.

Single sign-on via SAML or OIDC. Inbound enrolment over HL7 v2 ADT or FHIR R4 Encounter. Optional outbound flowsheet or note write-back. Designed to be an additional signal the nursing team already knows how to route, not a new portal to staff.

SAML 2.0OIDCHL7 v2 ADTFHIR R4ISO 27001IEC 62304