EyeBOX

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

Company Name

Oculogica

Product URL

https://oculogica.com/eyeBOX

Company URL

https://oculogica.com

Categories

• diagnostic Support
• clinical Care
• patient Facing
• Diagnostic
• Clinical

Summary

EyeBOX is a non-invasive, FDA-cleared device that objectively diagnoses concussions by analyzing eye movements, providing results in under four minutes without requiring a baseline test.

Description

EyeBOX is a lightweight, battery-operated device designed to aid in the diagnosis of concussions by measuring abnormalities in eye movements. It is FDA-cleared for use in both pediatric and adult patients, offering a non-invasive, baseline-free test that delivers results in less than four minutes. The device is suitable for various settings, including clinical environments and sports facilities, and has been validated through multiple peer-reviewed studies.

Api Available

unknown

Certifications

• FDA 510(k)
• CE Mark
• ISO 13485
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 60601-1-8
• IEC 60601-1-11
• IEC 60601-1-12
• IEC 60601-1-14
• IEC 60601-1-15
• IEC 60601-1-16
• IEC 60601-1-17
• IEC 60601-1-18
• IEC 60601-1-19
• IEC 60601-1-20
• IEC 60601-1-21
• IEC 60601-1-22
• IEC 60601-1-23
• IEC 60601-1-24

Company Founding

2018

Company Offices

• United States

Compliance

• HIPAA
• FDA 510(k)
• ISO 13485
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 60601-1-8
• IEC 60601-1-11
• IEC 60601-1-12
• IEC 60601-1-14
• IEC 60601-1-15
• IEC 60601-1-16
• IEC 60601-1-17
• IEC 60601-1-18
• IEC 60601-1-19
• IEC 60601-1-20
• IEC 60601-1-21
• IEC 60601-1-22
• IEC 60601-1-23
• IEC 60601-1-24

Customers

Data Residency

US-based data centers

Data Standards

• HL7 v2
• FHIR
• DICOM

Deployment Model

• on_prem
• SaaS

Features

• FDA-cleared concussion diagnostic device
• Non-invasive, baseline-free testing
• Objective assessment using eye-tracking technology
• Rapid test duration under 4 minutes
• Immediate results with BOX score report
• Portable and lightweight design
• Suitable for patients aged 5 to 67
• Clinically validated with multiple peer-reviewed studies
• Battery-operated for flexible use
• No literacy or language requirements for patients

Id

SW0498

Integration Partners

Integrations

• Electronic Health Records (EHR) systems
• Patient Management Systems
• Clinical Decision Support Systems

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb
• consumer

Optional Modules

Os Platforms

• Windows
• Linux

Pricing Details

Contact vendor for pricing information.

Pricing Model

subscription

Privacy Features

• Business Associate Agreement (BAA)
• Data Minimization
• Patient Consent Management
• Data Anonymization
• Data Encryption
• Access Control
• Audit Trails
• Data Retention Policies
• Data Deletion Procedures
• Data Masking

Product Code

SW0498

Product Name

EyeBOX

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
• Role-Based Access Control (RBAC)
• Audit Logs
• Secure Data Transmission
• Data Anonymization
• User Authentication
• Data Integrity Checks
• Access Control Lists (ACLs)
• Session Management
• Data Masking

Specialties

• Neurology
• Sports Medicine
• Pediatrics
• Emergency Medicine

Support Channels

System Requirements

Windows 10 or later, Linux kernel 4.0 or later

Target Users

• clinicians
• nurses
• patients
• admins
• payers

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "EyeBOX",
  "company_name": "Oculogica",
  "product_url": "https://oculogica.com/eyeBOX",
  "company_url": "https://oculogica.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0498",
  "summary": "EyeBOX is a non-invasive, FDA-cleared device that objectively diagnoses concussions by analyzing eye movements, providing results in under four minutes without requiring a baseline test.",
  "description": "EyeBOX is a lightweight, battery-operated device designed to aid in the diagnosis of concussions by measuring abnormalities in eye movements. It is FDA-cleared for use in both pediatric and adult patients, offering a non-invasive, baseline-free test that delivers results in less than four minutes. The device is suitable for various settings, including clinical environments and sports facilities, and has been validated through multiple peer-reviewed studies.",
  "categories": [
    "diagnostic Support",
    "clinical Care",
    "patient Facing",
    "Diagnostic",
    "Clinical",
    "Patient-facing"
  ],
  "market_segment": [
    "enterprise",
    "smb",
    "consumer"
  ],
  "target_users": [
    "clinicians",
    "nurses",
    "patients",
    "admins",
    "payers"
  ],
  "specialties": [
    "Neurology",
    "Sports Medicine",
    "Pediatrics",
    "Emergency Medicine"
  ],
  "regions_available": [
    "United States"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "commercial",
  "company_offices": [
    "United States"
  ],
  "company_founding": "2018",
  "deployment_model": [
    "on_prem",
    "SaaS"
  ],
  "os_platforms": [
    "Windows",
    "Linux"
  ],
  "features": [
    "FDA-cleared concussion diagnostic device",
    "Non-invasive, baseline-free testing",
    "Objective assessment using eye-tracking technology",
    "Rapid test duration under 4 minutes",
    "Immediate results with BOX score report",
    "Portable and lightweight design",
    "Suitable for patients aged 5 to 67",
    "Clinically validated with multiple peer-reviewed studies",
    "Battery-operated for flexible use",
    "No literacy or language requirements for patients"
  ],
  "optional_modules": [],
  "integrations": [
    "Electronic Health Records (EHR) systems",
    "Patient Management Systems",
    "Clinical Decision Support Systems"
  ],
  "data_standards": [
    "HL7 v2",
    "FHIR",
    "DICOM"
  ],
  "api_available": "unknown",
  "system_requirements": "Windows 10 or later, Linux kernel 4.0 or later",
  "compliance": [
    "HIPAA",
    "FDA 510(k)",
    "ISO 13485",
    "IEC 60601-1",
    "IEC 60601-1-2",
    "IEC 60601-1-6",
    "IEC 60601-1-8",
    "IEC 60601-1-11",
    "IEC 60601-1-12",
    "IEC 60601-1-14",
    "IEC 60601-1-15",
    "IEC 60601-1-16",
    "IEC 60601-1-17",
    "IEC 60601-1-18",
    "IEC 60601-1-19",
    "IEC 60601-1-20",
    "IEC 60601-1-21",
    "IEC 60601-1-22",
    "IEC 60601-1-23",
    "IEC 60601-1-24"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE Mark",
    "ISO 13485",
    "IEC 60601-1",
    "IEC 60601-1-2",
    "IEC 60601-1-6",
    "IEC 60601-1-8",
    "IEC 60601-1-11",
    "IEC 60601-1-12",
    "IEC 60601-1-14",
    "IEC 60601-1-15",
    "IEC 60601-1-16",
    "IEC 60601-1-17",
    "IEC 60601-1-18",
    "IEC 60601-1-19",
    "IEC 60601-1-20",
    "IEC 60601-1-21",
    "IEC 60601-1-22",
    "IEC 60601-1-23",
    "IEC 60601-1-24"
  ],
  "security_features": [
    "Encryption",
    "Role-Based Access Control (RBAC)",
    "Audit Logs",
    "Secure Data Transmission",
    "Data Anonymization",
    "User Authentication",
    "Data Integrity Checks",
    "Access Control Lists (ACLs)",
    "Session Management",
    "Data Masking"
  ],
  "privacy_features": [
    "Business Associate Agreement (BAA)",
    "Data Minimization",
    "Patient Consent Management",
    "Data Anonymization",
    "Data Encryption",
    "Access Control",
    "Audit Trails",
    "Data Retention Policies",
    "Data Deletion Procedures",
    "Data Masking"
  ],
  "data_residency": "US-based data centers",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0498",
  "slug": "eyebox",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/eyebox.json"
  }
}