Our approach
This is how Limbus is designed to work.
Status SaMD in development Health Canada authorization pending As of June 2026
The designed pathway
The pathway, end to end.
The same designed sequence runs every assessment: guided intake, structured screening, structured interview, and psychiatrist review at the end.
- 01
Stage 01
Guided intake
- 02
Stage 02
Structured screening
- 03
Stage 03
Structured interview
- 04
The human acts here
Psychiatrist review
Validity and safety gates run alongside every assessment. Flagged cases are routed to clinician review. None are auto-resolved.
Human oversight
Nothing is finalized without a psychiatrist.
Limbus is designed so that every case is reviewed by a psychiatrist before any diagnosis is finalized. The system gathers and organizes evidence; the reviewing clinician questions it, corrects it, and decides. The clinician owns the clinical decision. That is the design, not a disclaimer.
Built-in safety and validity gates are part of the same design. Checks for inconsistent responses, risk indicators, and presentations that fall outside the intended scope are surfaced for clinician attention rather than resolved automatically.
Where the picture is uncertain, Limbus is built to say so, and to defer to the reviewing clinician rather than over-claim.
Methodology
Assessment as evidence accumulation.
Limbus treats assessment as evidence accumulation, not pattern-matching to a label. Each finding updates a structured clinical picture, and the picture carries its uncertainty with it. That uncertainty is stated, not hidden.
This is the Bayesian-rigorous core of the design: evidence is weighed in a way a reviewing clinician can follow and challenge. Where evidence is weak or conflicting, the system is built to be conservative by design. It is built to say what the evidence does not yet support, and to defer to the reviewing clinician.
Interview design
Structured, adaptive, and bounded.
The interview is structured: it follows a designed sequence of clinical questions, not an open-ended conversation. It is adaptive within that structure, meaning follow-up questions respond to what has already been said. And it is bounded: what it asks, and what it is designed to assess, is fixed in advance.
The goal is to organize the clinical encounter, not replace it. An assessment that arrives structured, with its evidence attached, is designed to give the reviewing psychiatrist a better starting point, not a finished answer.
Validation — planned
How we'll validate.
Validation will be designed as formal study work, not marketing. We will specify the study design before results exist: what will be measured, in which population, against what reference standard, and what would count as failure.
The comparison that matters will be against clinicians. Planned validation will place the system’s structured summaries alongside psychiatrist assessments under a protocol written for that comparison, and the protocol will be set down before the data are collected.
Regulatory review will be part of the same process. The evidence will go to the regulator for scrutiny, and what we publish here will follow what that review permits. Nothing will be announced ahead of it.
Validation results will be published here only when they exist and authorization permits.
Regulatory status — as of June 2026
Limbus is a software medical device in development. Authorization from Health Canada is pending, and Limbus is not yet authorized for clinical use (as of June 2026).
Limbus is a software medical device intended to support, not replace, clinical decision-making. It is being taken through the Health Canada authorization process. Authorization is pending and has not been granted. Until it is, Limbus is in development and not for clinical use.
We do not make claims about diagnostic accuracy or clinical efficacy. Those will be established through formal study and regulatory review before we share any results.
If you want to follow this work as it develops, join the waitlist.
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Status In development Pending regulatory authorization Not a diagnostic device