Cognoa ASD Diagnosis Aid

by Cognoa  · Based in United States → — Transforming pediatric healthcare with early, rapid, and equitable diagnosis of autism.
Neurology Pediatrics Psychiatry
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Regulatory Status Disclosed

Overview

Cognoa’s ASD Diagnosis Aid, known as Canvas Dx, is a pioneering AI-based software as a medical device designed to assist healthcare providers in the diagnosis of Autism Spectrum Disorder (ASD) in young children. It aims to address the significant delays in autism diagnosis, which often prevent children from accessing critical early interventions. The tool integrates input from multiple sources: a mobile app for parents/caregivers to answer questionnaires and upload videos of their child’s behavior, a portal for trained video analysts to review these videos, and a web portal for healthcare providers to input their clinical observations and review the comprehensive report generated by the AI algorithm. Canvas Dx is intended for use as an adjunct to the diagnostic process, not as a stand-alone diagnostic device, for patients aged 18 months through 72 months who are at risk for developmental delay. The platform is designed to provide objective, data-driven insights, helping to mitigate biases and inequities in the diagnostic process across various demographics.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-based diagnostic algorithm
  • Caregiver mobile app for questionnaires and video uploads
  • Healthcare provider web portal for clinical input and report review
  • Trained video analyst portal for behavioral observation
  • Automated diagnostic report generation
  • Maps concerns to DSM-5 compatible criteria
  • Supports objective and equitable evaluation across demographics
  • Designed for use in primary and secondary care settings
  • Provides actionable insights for next steps in care
  • No special training or certification required for clinicians to use the tool

Use Cases

  • Early diagnosis of Autism Spectrum Disorder (ASD)
  • Reducing diagnostic delays for children at risk of developmental delay
  • Empowering primary care physicians to make informed diagnostic decisions
  • Identifying developmental strengths and concerns in children
  • Facilitating faster access to early intervention services
  • Streamlining documentation for services and reimbursement

What Physicians Need to Know

Purpose
Cognoa ASD Diagnosis Aid (branded as Canvas Dx) is the first FDA-authorized AI-driven diagnostic aid designed to help primary care physicians diagnose or rule out Autism Spectrum Disorder (ASD) in children aged 18 months through 6 years.
Patient Safety Guardrails
The device is FDA-authorized and intended for prescription use only, serving as an adjunct to the diagnostic process, not a stand-alone diagnostic tool. A critical safety feature is its ability to report 'No Result' when there is insufficient information, deliberately abstaining from a prediction to reduce the risk of false positives or negatives. Potential risks include misdiagnosis or delayed diagnosis due to false results.
Outcome Measurement
Clinical studies demonstrate high accuracy, with a Positive Predictive Value (PPV) of 95% and a Negative Predictive Value (NPV) of 97% for determinate results. It aims to shorten the diagnostic journey, enabling earlier intervention during critical neurodevelopmental windows.
Provider Dashboard
Healthcare providers utilize a dedicated portal to input patient information, track data provided by parents/caregivers, and review a comprehensive report of the AI's results. This portal includes features for generating diagnostic reports, which can save time and assist with documentation required for services and reimbursement.
Cultural Sensitivity
The AI algorithm was trained using diverse datasets, encompassing various races, genders, educational levels, and socioeconomic statuses, to help mitigate existing biases and disparities in the autism diagnostic process.
Physician Tip

Cognoa ASD Diagnosis Aid (Canvas Dx) is a valuable tool for primary care physicians to facilitate earlier and more equitable ASD diagnoses. Remember it is an *aid* and not a standalone diagnostic. Integrate its results with your clinical judgment, patient history, and other clinical evidence. Utilize the detailed reports to inform next steps, whether it's confirming an ASD diagnosis, ruling it out, or pursuing further evaluation for indeterminate results or other developmental concerns. The tool's ability to provide a 'No Result' outcome is a safety feature, indicating when more clinical investigation is needed.

The Cognoa ASD Diagnosis Aid operates through a multi-component system, including a mobile app for caregivers and a web-based portal for healthcare providers and trained video analysts. While direct integrations with Electronic Health Records (EHRs) are not explicitly detailed in the provided information, its design with a provider portal and report generation capabilities suggests a workflow intended to fit within clinical practice, supporting documentation for services and reimbursement.

Details

Category Mental & Behavioral Health AI, Neurology AI
Pricing Contact for pricing — Contact for pricing
DeploymentCloud-based (web portal and mobile app)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Cognoa ASD Diagnosis Aid (Canvas Dx) received FDA marketing authorization on June 2, 2021, via a De Novo classification request (DEN200069). It is the first FDA-authorized diagnosis aid designed to help physicians diagnose autism in children aged 18 months through 72 months in the primary care setting. It is intended for prescription use only and as an adjunct to the diagnostic process, not a stand-alone diagnostic device.
Integrations
EHR Not specified
Specialties Neurology, Pediatrics, Psychiatry

What the Web Says

The Cognoa ASD Diagnosis Aid is an AI-powered software designed to assist physicians in diagnosing autism spectrum disorder (ASD) in children aged 18 months to 5 years. It analyzes video uploads of a child's behavior and answers to a questionnaire from parents or caregivers. The device received FDA authorization as the first of its kind, aiming to reduce diagnostic delays and improve access to early intervention.

Overall: Positive

Strengths

  • FDA-authorized, providing a level of clinical validation and trust.
  • Potential to significantly reduce diagnostic delays for ASD, leading to earlier intervention.
  • Increases access to diagnosis, particularly for families in underserved areas or those facing long waitlists.
  • Utilizes AI and video analysis, offering an objective and data-driven approach.
  • Can be integrated into pediatric practice, streamlining the diagnostic process for physicians.
  • Non-invasive and convenient for families, as it can be used in a home setting.

Limitations

  • Relies on parental video submissions and questionnaire responses, which could introduce bias or variability.
  • Not a standalone diagnostic tool; it's an aid for physicians, requiring their interpretation and clinical judgment.
  • Potential for over-reliance on the technology, potentially diminishing the importance of direct clinical observation.
  • Concerns about data privacy and security, given the sensitive nature of the information collected.
  • Accessibility issues for families without reliable internet access or the technical ability to upload videos.
  • Some physicians may be hesitant to adopt new AI-driven diagnostic tools without extensive validation and training.

Based on reviews from: FDA, Cognoa Official Website, Healthcare IT News, MedTech Dive, Pediatric News, Reddit (various medical/parenting subreddits)

Last updated: 2026-07-17

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Press & Coverage

RAPS
FDA authorizes new device to help diagnose pediatric autism
The FDA authorized the marketing of Cognoa's ASD Diagnosis Aid, a first-of-its-kind machine learning-based software system, to help diagnose autism spectrum disorder in children aged 18 months through 5 years. The device's authorization through the de novo pathway establishes special controls for similar future devices.
2021-06
Contemporary Pediatrics
Cognoa ASD Diagnosis Aid authorized for marketing
The FDA granted marketing authorization to Cognoa, Inc. for its machine learning-based software to aid healthcare providers in diagnosing ASD in children aged 18 months to 5 years. The device consists of a mobile app for caregivers, a video analysis portal, and a healthcare provider portal.
2021-06
American Academy of Pediatrics (AAP News)
FDA authorizes marketing of tool to aid in diagnosis of autism spectrum disorder
The FDA authorized the marketing of the Cognoa ASD Diagnosis Aid, a novel medical device to help diagnose ASD in patients 18 months through 5 years. It is a machine learning-based software that uses an algorithm to interpret input from parents, video analysts, and healthcare providers.
2021-09
MedTech Dive
Cognoa's machine learning software for autism diagnosis gets FDA nod
The FDA authorized Cognoa's machine learning-based software for diagnosing ASD in children 18 months to five years old, following a clinical trial where the algorithm provided a positive or negative result in 32% of patients with high accuracy. The authorization came through the De Novo pathway, establishing special controls for this new type of medical device.
2021-06
PR Newswire
FDA Authorizes Marketing of Diagnostic Aid for Autism Spectrum Disorder
The U.S. FDA authorized marketing of the Cognoa ASD Diagnosis Aid, a machine learning-based software to help healthcare providers diagnose ASD in children aged 18 months through 5 years. This action created a new regulatory classification, allowing similar future devices to go through the FDA's 510(k) premarket process.
2021-06
Psychology Today
AI Device Helps Diagnose Autism in Children
A peer-reviewed study published in npj Digital Medicine evaluated the Cognoa ASD Diagnosis Aid, an AI machine learning Software as a Medical Device (SaMD), which helped primary care providers assess ASD in young children. The device, developed by Stanford Associate Professor Dennis Wall, showed high predictive accuracy in clinical trials.
2022-05
New York State Department of Health
Canvas Dx as a Diagnostic Aid for Autism in Young Children Health Technology Assessment
This health technology assessment reviews the Cognoa ASD Diagnosis Aid, marketed as Canvas Dx, a software as a medical device designed to assist healthcare providers in evaluating children with suspected ASD. The report summarizes clinical evidence and recommendation findings, noting no identified clinical practice guidelines specifically referencing the device.
2024-11
APA Services
Expanding the treatment toolkit: FDA-approved and cleared medical devices
The Cognoa ASD Diagnosis Aid, renamed Canvas Dx, is listed as an FDA-approved device that aids in the diagnosis of ASD for children aged 18-72 months who are at risk for developmental delay. It received De Novo classification on June 2, 2021.
2026-03

Videos

Product demos, reviews, and walkthroughs for Cognoa ASD Diagnosis Aid.

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Frequently Asked Questions

Cognoa ASD Diagnosis Aid, marketed as Canvas Dx, is an FDA-authorized prescription-only software as a medical device intended to assist healthcare providers in diagnosing Autism Spectrum Disorder (ASD) in children aged 18 months to 6 years who are at risk for developmental delay. The workflow involves caregivers using a mobile app to answer questions and upload videos, trained specialists analyzing these videos, and the physician reviewing a report generated by the AI algorithm, which is then used as an adjunct to their clinical judgment and patient history.
Cognoa ASD Diagnosis Aid received De Novo classification and FDA marketing authorization in June 2021, making it the first FDA-authorized diagnosis aid for autism. It is classified as a Class II medical device and is restricted to prescription use.
The device is not a stand-alone diagnostic tool and must be used in conjunction with patient history, clinical observations, and other evidence. In a pivotal study, it did not generate a definitive result for 68% of patients, and risks include potential misdiagnosis or delayed diagnosis due to false positives or false negatives. The device may also give unreliable results in patients with certain co-occurring conditions like known deafness or blindness.
Traditional ASD diagnosis typically relies on specialist evaluations using instruments like the Autism Diagnostic Interview-Revised (ADI-R) and Autism Diagnostic Observation Schedule (ADOS), which often involve long wait times. While the device showed good sensitivity (98.4%) and specificity (78.9%) for the 32% of patients for whom it provided a definitive result, it is designed to aid, not replace, comprehensive clinical assessment.
Information suggests the cost for a miscellaneous package of Canvas Dx Diagnosis Aid Autism can be around $1,860.20 with a SingleCare savings card. Wyoming Medicaid has become the first state to cover the cost of Cognoa's Canvas Dx, indicating a potential for broader insurance coverage in the future.
The AI algorithm of Canvas Dx was trained using diverse datasets encompassing race, gender, educational level, and socioeconomic status, aiming to help primary care physicians avoid existing biases and disparities in the autism diagnostic process. This approach is intended to promote more objective and equitable evaluations for children from various backgrounds.

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More from Cognoa

Canvas Dx
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Canvas Dx by Cognoa is the first FDA-authorized AI diagnostic aid for autism in children 1.5-6 years, enabling rapid and equitable diagnosis for primary care physicians.
Contact for pricing

View company profile →

Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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