EarliPoint System

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

Company Name

EarliTec Diagnostics

Product URL

https://earlitecdx.com

Company URL

https://earlitecdx.com

Categories

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

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.

Api Available

unknown

Certifications

• FDA 510(k) clearance

Company Founding

2020

Company Offices

• United States

Compliance

• FDA 510(k) clearance
• Clinical validation studies

Customers

Data Residency

US-based data storage

Data Standards

• FDA 510(k) clearance
• Clinical validation studies

Deployment Model

• SaaS

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

Id

SW0061

Integration Partners

Integrations

• Clinical workflows
• Provider systems

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• Operator module for session management
• Web portal for data handling and result retrieval

Os Platforms

• Web

Pricing Details

Contact vendor for pricing information.

Pricing Model

enterprise_quote

Privacy Features

• Data anonymization
• Consent management
• Data minimization

Product Code

SW0061

Product Name

EarliPoint System

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

• Data encryption
• Secure data storage
• Compliance with healthcare data security standards

Specialties

• Pediatrics
• Neurology
• Psychology
• Behavioral Health
• Developmental Disorders

Support Channels

System Requirements

Target Users

• clinicians
• pediatricians
• neurologists
• psychologists
• behavioral therapists

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "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"
  }
}