EarliPoint

JSON twin: https://www.healthaidb.com/software/earlipoint.json

Company Name

EarliTec Diagnostics

Product URL

https://earlitec.com/earlipoint

Company URL

https://earlitec.com

Categories

• clinical Care
• diagnostic Support
• pediatric Care
• neurology
• behavioral Health
• Clinical
• Diagnostic
• Pediatric

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.

Api Available

unknown

Certifications

• FDA 510(k) clearance

Company Founding

2019

Company Offices

• United States

Compliance

• HIPAA
• FDA 510(k) clearance

Customers

Data Residency

US-only

Data Standards

• HL7 FHIR
• HL7 v2.x
• DICOM

Deployment Model

• SaaS

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

Id

SW0339

Integration Partners

Integrations

• EHR systems
• health information exchanges

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

Os Platforms

• Web

Pricing Details

Contact vendor for pricing information.

Pricing Model

enterprise_quote

Privacy Features

• BAA available
• data anonymization
• data minimization

Product Code

SW0339

Product Name

EarliPoint

Ratings

Regions Available

• United States

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

Security Features

• encryption at rest
• encryption in transit
• RBAC
• audit logs

Specialties

• Pediatrics
• Neurology
• Psychology
• Speech Therapy
• Occupational Therapy

Support Channels

System Requirements

Target Users

• clinicians
• pediatricians
• neurologists
• psychologists
• speech therapists
• occupational therapists

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "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"
  }
}