01Statement
Path-iQ is a software platform for digital pathology workflows, used by qualified healthcare and laboratory professionals to view, annotate, and report on pathology cases. AI features within Path-iQ are assistive — they surface regions of interest, segment structures, and produce quantitative outputs to support pathologist review. They do not produce final diagnostic conclusions.
02Intended use
Path-iQ is intended for use by:
- Licensed pathologists and pathology residents (where supervised).
- Histotechnologists and laboratory technicians supporting case preparation and quality control.
- Laboratory administrators managing case routing and workflow.
- Authorised clinical reviewers participating in tumour boards, second-opinion review, or QA.
Use is permitted for: diagnostic workflow support, second-opinion review, tumour board preparation, QA review, teaching, and research with appropriate consent and IRB review.
03Not intended for
- Direct patient consumption. Path-iQ is not a patient-facing app and does not provide medical advice to patients.
- Autonomous diagnosis. Path-iQ does not generate diagnostic conclusions without pathologist review and sign-out.
- Use outside stated indications. Each AI model is evaluated for clinical validity within specific indications (organ type, stain, modality). Outside stated indications, AI is suppressed or flagged.
- Use on unverified workflows. Customers must validate suitability for their specific scenarios during onboarding.
- Use in jurisdictions where Path-iQ is not authorised. Regulatory status varies. See section 9.
04Pathologist sign-out
Every diagnostic report generated through Path-iQ is reviewed and signed out by a licensed pathologist. The pathologist is the named decision-maker on the case. AI outputs may inform the pathologist's review but do not replace clinical judgement. The pathologist may accept, modify, or reject AI outputs; the signed-out conclusion is the diagnostic record.
05Limitations
Path-iQ may not be appropriate for all clinical scenarios, all stains, all tissue types, all scanners, or all patient populations. Limitations include but are not limited to:
- AI performance varies by stain, organ system, and scanner type. Performance summaries are provided during onboarding.
- Scanned image quality (focus, artefacts, batch variability) can affect both human review and AI outputs.
- AI outputs are point-in-time estimates and should not be interpreted as absolute measurements without pathologist review.
- Mobile devices may not be appropriate for all review tasks. High-resolution diagnostic review is intended for validated workstations.
06Patients
07Emergencies
Path-iQ is not designed for emergency use. If you or someone you know is experiencing a medical emergency, call your local emergency number immediately (e.g. 911 in the US, 112 in the EU, 997 in Saudi Arabia).
08Adverse events & safety concerns
Report any clinical safety concern — including a suspected AI failure, a workflow failure that contributed to patient harm, or a near-miss — to rahul.wasnik@pathiq.cloud with the subject line "Clinical Safety Concern". Reports are triaged at incident-level priority. We maintain an internal review process for all reported issues and will follow up with the customer and, where required by law, with relevant authorities.
09Regulatory status
Regulatory clearance for Path-iQ varies by jurisdiction, configuration, and intended use. Some configurations of Path-iQ are positioned as workflow software; some include modules that may be regulated as medical devices in certain jurisdictions. Customers are responsible for ensuring use complies with applicable regulations in their jurisdiction. Reach out to rahul.wasnik@pathiq.cloud for the current regulatory status in your region.
10Contact
For clinical safety questions, contact rahul.wasnik@pathiq.cloud.