App & Assessment · Self-guided
FDA-authorized AI for autism spectrum disorder diagnosis in children
Canvas Dx is the first FDA-authorized AI-based diagnostic aid for autism spectrum disorder, helping clinicians diagnose ASD in children ages 18 months to 6 years with high accuracy.
Reviewed by HeyPsych Board · 2026-09-02
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FDA-authorized as prescription-only diagnostic device. Must be ordered by healthcare provider.
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Cognoa Canvas Dx is a digital therapeutic and mental health measurement tool. FDA-authorized AI for autism spectrum disorder diagnosis in children It is designed for: Pediatricians wanting to screen for autism in-office, Health systems reducing autism diagnosis wait times, Developmental clinics increasing diagnostic capacity.
Canvas Dx is the first FDA-authorized AI-based diagnostic aid for autism spectrum disorder. It helps clinicians diagnose ASD in children ages 18 months to 6 years by combining caregiver questionnaires, video analysis, and provider assessments.
Canvas Dx has 95% specificity (correctly identifying children without ASD) and 97% negative predictive value. It was validated in clinical trials and received FDA De Novo authorization in 2021.
Canvas Dx is a prescription-only diagnostic device that must be ordered by a licensed healthcare provider such as a pediatrician, developmental pediatrician, or child psychiatrist.
Canvas Dx typically costs $300-600 per assessment. It may be covered by commercial insurance or Medicaid in some states. Health systems can get volume pricing for broader implementation.
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