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Last updated: June 7, 2026
Back to directoryCognoa Canvas Dx medical AI product profile
FDA De Novo-authorized autism diagnostic aid that combines caregiver input, clinician assessment, and video review to help trained providers diagnose or rule out ASD in eligible young children.
Patient access, triage, and agents
Best fit
Organizations trying to shorten autism evaluation wait times while keeping diagnosis, eligibility screening, result interpretation, family communication, and next-step care planning under qualified clinician control.
- Primary use case
- Prescription AI-based autism spectrum disorder diagnosis aid for children ages 18 to 72 months who are at risk for developmental delay and are evaluated by qualified healthcare providers
- Audience
- Pediatric primary care, developmental-behavioral pediatrics, autism evaluation programs, health plans, Medicaid programs, and child-development access teams
- Risk level
- High
- Pricing signal
- Commercial, payer, and Medicaid coverage terms should be verified with Cognoa for the current state, plan, prescriber, telehealth, and reimbursement workflow.
- Official sources
- 8 official sources
Compare within workflow: Patient access, triage, and agents · comparison shortlist · source index
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating Cognoa Canvas Dx as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Treat as regulated pediatric diagnostic software. Match use to DEN200069, prescription-only status, age range, qualified HCP interpretation, adjunctive role, language/device prerequisites, exclusions, and any current labeling or software-version changes before launch. |
|---|---|
| Privacy | Review child videos, caregiver and clinician questionnaires, child demographics, insurance details, HCP portal data, reports, SMS support, service providers, telemedicine partners, FDA or IRB disclosures, retention, de-identification, and customer agreement terms before routing families through the workflow. |
| Evidence | Use Cognoa's clinical research and FDA summary as starting evidence, then monitor local eligibility, indeterminate outputs, diagnostic agreement, false reassurance risk, referral burden, equity, family experience, and downstream access to early intervention. |
| Workflow | Best governed as a clinician-supervised autism evaluation accelerator with explicit prescribing criteria, family instructions, report interpretation, specialist escalation for indeterminate or complex cases, and documented next-step care planning. |
Where Cognoa Canvas Dx fits
Cognoa describes Canvas Dx as an FDA-authorized AI and machine-learning diagnostic system for diagnosing or ruling out autism in children ages 1.5 to 6 years; FDA's De Novo record for DEN200069 classifies the Cognoa ASD Diagnosis Aid as a pediatric autism spectrum disorder diagnosis aid, and Cognoa's indications state it is prescription-only, adjunctive, and intended for trained healthcare professionals using patient history, clinical observations, and other evidence.
Not for: Standalone diagnosis, broad developmental screening, emergency behavioral-health triage, older children, children outside the indications for use, or replacing comprehensive specialist evaluation when the result is indeterminate or clinically discordant.
What to verify before using Cognoa Canvas Dx
- FDA De Novo DEN200069, prescription-only status, indications for use, age range, caregiver language and smartphone requirements, exclusions, and whether any later cleared version is being deployed.
- How caregiver questionnaires, child videos, healthcare-provider questionnaires, scoring technicians, final reports, and qualified clinician interpretation fit the local diagnostic pathway.
- Privacy handling for child identifiers, demographic and insurance data, caregiver responses, videos, HCP portal data, report sharing, de-identified research or product-improvement use, SMS support, and third-party service providers.
- Local performance for eligible children, indeterminate results, referrals, specialist wait times, equity, family comprehension, follow-up completion, false positives, false negatives, and clinician override or escalation decisions.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- cognoa.com
- cognoa.com / for-providers
- cognoa.com / clinical-research
- cognoa.com / ifu
- www.accessdata.fda.gov / scripts / cdrh
- www.accessdata.fda.gov / cdrh_docs / reviews
- app.cognoa.com / link / privacy-policy
- cognoa.com / terms-conditions
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