Company profile

Cognoa

Pathology & Laboratory Diagnostics

Company profile

About Cognoa

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

Primary marketPathology & Laboratory Diagnostics
Commercial modelCommercial information available on request
Company presenceOfficial website
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01 · Operating footprint

Where the Company operates

Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.

Clinical focus

  • Autism Spectrum Disorder
  • developmental conditions
  • pediatric behavioral health conditions

Who it serves

  • Clinicians
  • Families & Caregivers
  • Health Systems
  • Healthcare Providers
  • Payers

Deployment & integration

Cloud Saas deployment with recorded integration context.

Geographic context

MarketsUnited States
Company sourceOfficial website

Company milestones

Platform expansion

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

Recorded partners

  • Harvard Medical School's Center for Biomedical Informatics
  • Highmark Insurance
  • Wyoming Medicaid

02 · Flagship portfolio

Products, workflows, and platform capabilities

Selected source-backed Company products and the available commercial context.

Canvas Dx

FDA authorized AI-powered diagnostic solution for autism in children ages 1.5-6 years

Software · Cloud SaaSCompany source

03 · Research intelligence

Research Intelligence evidence

Publications, preprints, clinical validation, and regulatory records in Evidence Position order.

Evidence position

Publications, clinical validation, and regulatory records connected to this Company appear here.

Research

Publications & preprints

Integration of an Artificial Intelligence-Based Autism Diagnostic Device into the ECHO Autism Primary Care Workflow: Prospective Observational Study.

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

Clinical-trial records

Cognoa ASD Diagnostic Device - Data Collection Study

NCT03871179 · Sponsor · WITHDRAWN

Extension for Community Healthcare Outcomes (ECHO) Autism Diagnostic Study in Primary Care Setting

NCT05223374 · Sponsor · COMPLETED

Cognoa Autism Spectrum Disorder (ASD) Digital Therapeutic Engagement and Usability Study

NCT04326231 · Sponsor · TERMINATED

Cognoa ASD Diagnosis Aid Validation Study

NCT04151290 · Sponsor · COMPLETED

Regulatory

Regulatory records

Canvas Dx

K243558 · 510k · Apr 11, 2025

Cognoa ASD Diagnosis Aid

DEN200069 · De Novo · Jun 2, 2021

04 · Company-reported outcomes

Outcomes and case studies

Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.

Diagnosis within days instead of months or years

Time to autism diagnosis for children ages 1.5-6 years

2.5x cost savings

Early diagnosis costs healthcare system 2.5x less than delayed diagnosis

Reduces 3-year diagnostic delay

Most children diagnosed after age 4 vs. reliable diagnosis possible at 18 months

Wyoming Medicaid

First state Medicaid program to cover AI-powered autism diagnostic

Launched first state Medicaid coverage program for Canvas Dx

Highmark Insurance

Reimbursement coverage for Canvas Dx autism diagnostic solution

Canvas Dx is now reimbursed by Highmark Insurance

05 · Leadership

Leadership team

Leadership profiles and professional links from the current Company record.

06 · Company updates

Updates from Cognoa

Recent articles published on Cognoa's official website.

07 · HAIC coverage

Coverage and analysis

Health AI Central reporting that mentions this Company.

No HAIC coverage is currently linked to this Company.

08 · Official presence

Company sources and channels

Curated official destinations from the active Company record.

09 · Market pathway

Additional Companies in this Market

Other active Companies in the same market, selected alphabetically from the HAIC directory.

Market context

Pathology & Laboratory Diagnostics

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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10 · Pro research

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Expanded Company research is in development.

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Deeper Company research is coming soon.

Pro Research will introduce expanded technical context, linked evidence analysis, and comparative Company research.

ResearchEvidence analysis

Linked research, clinical, and regulatory source pathways.

CompanyTechnical context

Expanded product, deployment, integration, and partnership research.

MethodSource & review record

Record-level provenance and review context.

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