{"product_name":"EarliPoint","company_name":"EarliTec Diagnostics","product_url":"https://earlitec.com/earlipoint","company_url":"https://earlitec.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0339","summary":"EarliPoint is an FDA-cleared diagnostic tool that assists clinicians in early detection and assessment of autism in children aged 16 to 30 months by analyzing their eye-tracking responses to social interaction videos.","description":"EarliPoint Evaluation is a medical device developed by EarliTec Diagnostics to aid qualified clinicians in diagnosing and assessing Autism Spectrum Disorder (ASD) in children aged 16 to 30 months. Utilizing eye-tracking technology, it monitors a child's focus and responsiveness while watching short video scenes depicting social interactions. The device captures over 120 focal preferences per second, providing objective data that correlates with levels of social disability, verbal ability, and non-verbal learning. This objective measurement tool offers a more efficient and accurate method for early autism diagnosis compared to traditional observation-based approaches.","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","speech therapists","occupational therapists"],"specialties":["Pediatrics","Neurology","Psychology","Speech Therapy","Occupational Therapy"],"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":"2019","deployment_model":["SaaS"],"os_platforms":["Web"],"features":["Objective measurement of social-visual engagement","FDA-cleared diagnostic tool for autism in children aged 16-30 months","Captures and analyzes looking behavior imperceptible to the human eye","Provides data-driven insights for early diagnosis and intervention","Enables ongoing assessments to track developmental progress over time","Empowers clinicians with clear, measurable data to support diagnostic decisions","Supports early intervention to improve long-term outcomes for children","Helps in streamlining referrals and intervention processes","Offers objective data to build trust with parents and caregivers","Facilitates data-driven care for children with autism"],"optional_modules":[],"integrations":["EHR systems","health information exchanges"],"data_standards":["HL7 FHIR","HL7 v2.x","DICOM"],"api_available":"unknown","system_requirements":"","compliance":["HIPAA","FDA 510(k) clearance"],"certifications":["FDA 510(k) clearance"],"security_features":["encryption at rest","encryption in transit","RBAC","audit logs"],"privacy_features":["BAA available","data anonymization","data minimization"],"data_residency":"US-only","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0339","slug":"earlipoint","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/earlipoint.json"}}