Canvas Dx
FDA authorized AI-powered diagnostic solution for autism in children ages 1.5-6 years
Company profile
Company profile
Cognoa is an early childhood development and pediatric behavioral health company dedicated to enabling earlier and more equitable access to care that improves the lives and outcomes of children and families. The company has developed Canvas Dx, the first and only FDA-authorized diagnostic solution designed to equip clinicians to diagnose or rule out autism in children ages 1.5 to 6 years—within days, not months or years. Using responsible AI and a whole-child data approach, Cognoa addresses the critical gap in pediatric developmental health where most children with autism aren't diagnosed until after age 4, with many underserved children missed altogether. The company's remote, digital evaluation platform overcomes long distances to scarce specialty centers, provides a faster path to next steps for all children, and uses an objective, data-driven approach that alleviates prevalent biases in diagnoses. Canvas Dx has been developed over years of testing and clinical validation with results published in peer-reviewed journals. Cognoa's technology actively seeks diverse data and trains AI to represent and account for differences in gender, race, ethnicity, and socio-economic backgrounds. The company's whole-child data approach facilitates a robust pipeline for pediatric developmental and behavioral health, including multidimensional feature evaluation, tracking, and accessible therapies. Canvas Dx is now reimbursed by Highmark Insurance and has launched the first state Medicaid program coverage in Wyoming.
Company description Cognoa official website
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01 · Operating footprint
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Cloud Saas deployment with recorded integration context.
Company milestones
First state Medicaid program coverage launched in Wyoming (September 2024). Highmark Insurance reimbursement approved. FDA authorization achieved for Canvas Dx as first and only AI-powered autism diagnostic for ages 1.5-6 years.
Partnerships
02 · Flagship portfolio
Selected source-backed Company products and the available commercial context.
FDA authorized AI-powered diagnostic solution for autism in children ages 1.5-6 years
03 · Research intelligence
Publications, preprints, clinical validation, and regulatory records in Evidence Position order.
Publications, clinical validation, and regulatory records connected to this Company appear here.
Research
JMIR formative research · Oct 21, 2025
An analysis of the real world performance of an artificial intelligence based autism diagnostic.Scientific reports · Aug 12, 2025
Economics and Equity of Large Language Models: Health Care Perspective.Journal of medical Internet research · Nov 14, 2024
Promises, Pitfalls, and Clinical Applications of Artificial Intelligence in Pediatrics.Journal of medical Internet research · Feb 29, 2024
Autism Spectrum Disorder: The New Asthma?Clinical pediatrics · Jul 1, 2023
Increased delay from initial concern to diagnosis of autism spectrum disorder and associated health care resource utilization and cost among children aged younger than 6 years in the United States.Journal of managed care & specialty pharmacy · Apr 1, 2023
Clinical validation
NCT03871179 · Sponsor · WITHDRAWN
Extension for Community Healthcare Outcomes (ECHO) Autism Diagnostic Study in Primary Care SettingNCT05223374 · Sponsor · COMPLETED
Cognoa Autism Spectrum Disorder (ASD) Digital Therapeutic Engagement and Usability StudyNCT04326231 · Sponsor · TERMINATED
Cognoa ASD Diagnosis Aid Validation StudyNCT04151290 · Sponsor · COMPLETED
Regulatory
K243558 · 510k · Apr 11, 2025
Cognoa ASD Diagnosis AidDEN200069 · De Novo · Jun 2, 2021
04 · Company-reported outcomes
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
Time to autism diagnosis for children ages 1.5-6 years
Early diagnosis costs healthcare system 2.5x less than delayed diagnosis
Most children diagnosed after age 4 vs. reliable diagnosis possible at 18 months
First state Medicaid program to cover AI-powered autism diagnostic
Launched first state Medicaid coverage program for Canvas Dx
Reimbursement coverage for Canvas Dx autism diagnostic solution
Canvas Dx is now reimbursed by Highmark Insurance
05 · Leadership
Leadership profiles and professional links from the current Company record.
Dennis Wall
Founder
06 · Company updates
Recent articles published on Cognoa's official website.
07 · HAIC coverage
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08 · Official presence
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09 · Market pathway
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Market context
Companies applying AI to digital pathology, histopathology slide analysis, laboratory diagnostics, or biomarker discovery. Includes AI-powered interpretation of lab test results, at-home diagnostic devices with AI analysis, and platforms that analyze tissue samples or biological specimens to support clinical diagnosis.
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