{"product_name":"Canvas Dx","company_name":"Cognoa","product_url":"https://cognoa.com/products/canvas-dx","company_url":"https://cognoa.com/","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0043","summary":"Canvas Dx is an AI-powered diagnostic tool that enables healthcare providers to rapidly and accurately diagnose or rule out autism in children aged 18 months to 6 years, facilitating early intervention and support.","description":"Canvas Dx is the first FDA-authorized diagnostic aid designed to assist healthcare providers in diagnosing autism spectrum disorder (ASD) in children aged 18 to 72 months who are at risk for developmental delay. Utilizing AI and machine learning algorithms, it analyzes caregiver-provided information and physician inputs to generate a diagnostic prediction, aiming to shorten the diagnostic journey from months or years to just days. The tool is intended as an adjunct to the diagnostic process and is for prescription use only. It is not a standalone diagnostic device. Canvas Dx is now reimbursed by Highmark Insurance, expanding access to early autism diagnosis. Additionally, Wyoming Medicaid has become the first state to cover Canvas Dx, further enhancing accessibility for families seeking early evaluation and intervention for their children. The device is designed for use in both primary and specialty care settings and can be administered remotely, making it accessible to families regardless of geographic location. It is also intended to address existing biases in autism diagnoses by providing an objective, data-driven approach that is equitable across different racial, ethnic, and socioeconomic backgrounds. Canvas Dx is available in select states, including Florida, New Jersey, Pennsylvania, and Virginia, with plans for broader availability in the future. Families interested in using Canvas Dx can connect with a prescriber through Cognoa's website. Healthcare professionals can learn more about integrating Canvas Dx into their practice by visiting Cognoa's provider page.","categories":["diagnostic Support","clinical Care","pediatric Care","behavioral Health","ai Clinical Documentation Integrity","remote Care Management","health Equity","provider Tools","Diagnostic","Clinical","Pediatric","Behavioral Health","Ai-powered","Remote Assessment","Equity-focused","Healthcare Provider Tool","Early Intervention","Developmental Delay"],"market_segment":["enterprise","consumer","healthcare providers","insurance companies"],"target_users":["healthcare providers","clinicians","pediatricians","primary care physicians","parents","caregivers","children aged 18 months to 6 years"],"specialties":["Pediatrics","Behavioral Health","Developmental Disorders","Autism Spectrum Disorder","Primary Care","Neurology","Psychology","Speech And Language Pathology","Occupational Therapy","Early Childhood Education"],"regions_available":["United States","Florida","New Jersey","Pennsylvania","Virginia","Wyoming"],"languages_supported":["English"],"pricing_model":"subscription","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["United States","California","New York","Pennsylvania","Florida","New Jersey","Virginia","Wyoming"],"company_founding":"2014","deployment_model":["SaaS"],"os_platforms":["iOS","Web"],"features":["AI-powered autism diagnostic aid","Parent/caregiver questionnaire via app","Video analysis of child behavior","Healthcare provider portal for clinician input","Rapid diagnostic results within days","Equitable evaluation across demographics","Automated diagnostic report generation","Remote evaluation without in-person visits","FDA authorized for children 18 months to 6 years","Prescription use only"],"optional_modules":[],"integrations":["Highmark Insurance"],"data_standards":["FHIR","HL7 v2","DICOM","SNOMED","ICD-10"],"api_available":"no","system_requirements":"Compatible iOS device with internet access","compliance":["HIPAA","FDA 510(k)"],"certifications":["FDA 510(k)"],"security_features":["Data encryption","Secure data storage","Access controls","Audit logs"],"privacy_features":["Data anonymization","Consent management","Data minimization"],"data_residency":"US-based data centers","customers":["Cognoa","Canvas Dx"],"user_reviews":["Canvas Dx offers a highly customizable user interface, allowing developers to build custom workflows and integrate them into existing systems. However, clinicians may find it complex and not a no-code EMR platform. Integration with legacy systems is still uncertain.","Canvas Dx is affordable and convenient, but it lacks the ability to rebuild and customize chart bots."],"ratings":["3.0/5 Overall Rating, Capterra","5.0/5 Overall Rating, Capterra"],"support_channels":["email","phone","chat","ticketing","community","24x7"],"training_options":["documentation","webinars","live_online","onsite","certification"],"release_year":"2020","integration_partners":["Elation","athenaOne"],"id":"SW0043","slug":"canvas-dx","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/canvas-dx.json"}}