{"product_name":"EarliPoint System","company_name":"EarliTec Diagnostics","product_url":"https://earlitecdx.com","company_url":"https://earlitecdx.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0061","summary":"EarliPoint System is an FDA-cleared diagnostic tool that aids clinicians in assessing Autism Spectrum Disorder in children aged 16 to 30 months by analyzing their eye-tracking data during social interaction videos.","description":"EarliPoint System utilizes eye-tracking technology to objectively measure a child's social engagement, verbal ability, and non-verbal learning, providing clinicians with data to support early autism diagnosis and assessment in children as young as 16 months.","categories":["clinical Care","diagnostic Support","pediatric Care","neurology","behavioral Health","Clinical","Diagnostic","Pediatric","Neurology","Behavioral Health"],"market_segment":["enterprise","smb"],"target_users":["clinicians","pediatricians","neurologists","psychologists","behavioral therapists"],"specialties":["Pediatrics","Neurology","Psychology","Behavioral Health","Developmental Disorders"],"regions_available":["United States"],"languages_supported":["English"],"pricing_model":"enterprise_quote","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["United States"],"company_founding":"2020","deployment_model":["SaaS"],"os_platforms":["Web"],"features":["FDA-cleared tool for diagnosing Autism Spectrum Disorder (ASD) in children aged 16 to 30 months","Utilizes eye-tracking technology to monitor children's looking behavior during video sessions","Provides objective measurements of social disability, verbal ability, and non-verbal learning skills","Offers robust data to support clinicians in making confident and objective diagnoses","Aligns with expert clinical diagnoses, ensuring reliable data for assessment","Enables early diagnosis, potentially as young as 16 months, reducing wait times for answers","Allows for ongoing assessments to track a child's progress over time","Helps in reducing potential clinician biases, ensuring accurate early diagnosis for all children","Supports early intervention, leading to better outcomes and inclusion in regular classrooms","Provides a standardized, objective tool for families from all backgrounds","Offers cost-effective, long-term benefits by facilitating early intervention","Integrates seamlessly into clinical workflows, enhancing provider capacity and treatment enrollment","Provides measurable impact for families through objective assessment and diagnosis"],"optional_modules":["Operator module for session management","Web portal for data handling and result retrieval"],"integrations":["Clinical workflows","Provider systems"],"data_standards":["FDA 510(k) clearance","Clinical validation studies"],"api_available":"unknown","system_requirements":"","compliance":["FDA 510(k) clearance","Clinical validation studies"],"certifications":["FDA 510(k) clearance"],"security_features":["Data encryption","Secure data storage","Compliance with healthcare data security standards"],"privacy_features":["Data anonymization","Consent management","Data minimization"],"data_residency":"US-based data storage","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0061","slug":"earlipoint-system","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/earlipoint-system.json"}}