EyeArt

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

Company Name

Eyenuk

Product URL

https://www.eyenuk.com/us-en/products/eyeart/

Company URL

https://www.eyenuk.com

Categories

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

Summary

EyeArt is an AI-powered system developed by Eyenuk for autonomous diabetic retinopathy screening, providing rapid, in-clinic detection without the need for expert human grading or eye dilation.

Description

EyeArt is an AI-driven system designed for the autonomous detection of diabetic retinopathy (DR). It enables rapid, in-clinic screening by analyzing retinal images and generating detailed reports in under 60 seconds, facilitating timely diagnosis and referral decisions. The system has been extensively validated, demonstrating high sensitivity and specificity in real-world clinical settings. EyeArt is FDA-cleared, CE-marked as a Class IIb medical device in the European Union, and holds a Health Canada license, supporting its use in various healthcare settings globally.

Api Available

yes

Certifications

• FDA 510(k)
• CE Marking (Class IIb)
• Health Canada license

Company Founding

2010

Company Offices

• United States
• United Kingdom
• Germany
• India
• China
• Japan
• Brazil
• Mexico
• South Africa
• Australia

Compliance

• HIPAA
• GDPR
• SOC2 Type II
• ISO 13485:2016
• MDSAP

Customers

• Diabetes Clinic in Bad Mergentheim, Germany

Data Residency

US/EU regions

Data Standards

• DICOM
• HL7
• FHIR

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Automated diabetic retinopathy screening
• Image quality feedback
• International Clinical DR grading
• Single office visit screening
• Rapid result generation (under 1 minute)
• Integration with retinal imaging cameras
• Cloud-based design
• HIPAA compliance
• GDPR compliance
• SOC2 Type II compliance
• ISO 13485:2016 certification
• MDSAP certification

Id

SW0345

Integration Partners

• Canon CR-2 AF
• Canon CR-2 Plus AF
• Topcon NW400

Integrations

• Canon CR-2 AF
• Canon CR-2 Plus AF
• Topcon NW400
• EHR/EMR systems
• PACS systems

Languages Supported

• English
• Spanish
• French
• German
• Italian
• Portuguese
• Dutch
• Arabic
• Hebrew
• Turkish
• Russian
• Chinese
• Japanese
• Korean
• Hindi
• Bengali
• Punjabi
• Telugu
• Marathi
• Tamil
• Urdu

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• Age-related macular degeneration detection
• Glaucomatous optic nerve damage detection

Os Platforms

• Web

Pricing Details

Contact vendor for pricing information.

Pricing Model

subscription

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization

Product Code

SW0345

Product Name

EyeArt

Ratings

• 4.8/5 on G2.com

Regions Available

• United States
• European Union
• Canada
• Latin America
• Middle East

Related Urls

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

Release Year

2018

Security Features

• Encryption
• RBAC
• Audit logs
• 2FA

Specialties

• Diabetic Retinopathy
• Ophthalmology
• Optometry

Support Channels

• email
• phone
• chat
• ticketing
• community
• 24x7

System Requirements

Canon CR-2 AF, Canon CR-2 Plus AF, Topcon NW400 cameras

Target Users

• clinicians
• nurses
• patients
• admins

Training Options

• documentation
• webinars
• live_online
• onsite
• certification

Type

product

User Reviews

• EyeArt has been instrumental in our clinic's workflow, providing rapid and accurate diabetic retinopathy screenings.

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "EyeArt",
  "company_name": "Eyenuk",
  "product_url": "https://www.eyenuk.com/us-en/products/eyeart/",
  "company_url": "https://www.eyenuk.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0345",
  "summary": "EyeArt is an AI-powered system developed by Eyenuk for autonomous diabetic retinopathy screening, providing rapid, in-clinic detection without the need for expert human grading or eye dilation.",
  "description": "EyeArt is an AI-driven system designed for the autonomous detection of diabetic retinopathy (DR). It enables rapid, in-clinic screening by analyzing retinal images and generating detailed reports in under 60 seconds, facilitating timely diagnosis and referral decisions. The system has been extensively validated, demonstrating high sensitivity and specificity in real-world clinical settings. EyeArt is FDA-cleared, CE-marked as a Class IIb medical device in the European Union, and holds a Health Canada license, supporting its use in various healthcare settings globally.",
  "categories": [
    "diagnostic Support",
    "clinical Care",
    "patient Facing",
    "Diagnostic",
    "Clinical",
    "Patient-facing"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "clinicians",
    "nurses",
    "patients",
    "admins"
  ],
  "specialties": [
    "Diabetic Retinopathy",
    "Ophthalmology",
    "Optometry"
  ],
  "regions_available": [
    "United States",
    "European Union",
    "Canada",
    "Latin America",
    "Middle East"
  ],
  "languages_supported": [
    "English",
    "Spanish",
    "French",
    "German",
    "Italian",
    "Portuguese",
    "Dutch",
    "Arabic",
    "Hebrew",
    "Turkish",
    "Russian",
    "Chinese",
    "Japanese",
    "Korean",
    "Hindi",
    "Bengali",
    "Punjabi",
    "Telugu",
    "Marathi",
    "Tamil",
    "Urdu"
  ],
  "pricing_model": "subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "commercial",
  "company_offices": [
    "United States",
    "United Kingdom",
    "Germany",
    "India",
    "China",
    "Japan",
    "Brazil",
    "Mexico",
    "South Africa",
    "Australia"
  ],
  "company_founding": "2010",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web"
  ],
  "features": [
    "Automated diabetic retinopathy screening",
    "Image quality feedback",
    "International Clinical DR grading",
    "Single office visit screening",
    "Rapid result generation (under 1 minute)",
    "Integration with retinal imaging cameras",
    "Cloud-based design",
    "HIPAA compliance",
    "GDPR compliance",
    "SOC2 Type II compliance",
    "ISO 13485:2016 certification",
    "MDSAP certification"
  ],
  "optional_modules": [
    "Age-related macular degeneration detection",
    "Glaucomatous optic nerve damage detection"
  ],
  "integrations": [
    "Canon CR-2 AF",
    "Canon CR-2 Plus AF",
    "Topcon NW400",
    "EHR/EMR systems",
    "PACS systems"
  ],
  "data_standards": [
    "DICOM",
    "HL7",
    "FHIR"
  ],
  "api_available": "yes",
  "system_requirements": "Canon CR-2 AF, Canon CR-2 Plus AF, Topcon NW400 cameras",
  "compliance": [
    "HIPAA",
    "GDPR",
    "SOC2 Type II",
    "ISO 13485:2016",
    "MDSAP"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE Marking (Class IIb)",
    "Health Canada license"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "Audit logs",
    "2FA"
  ],
  "privacy_features": [
    "BAA available",
    "Consent management",
    "Anonymization",
    "Data minimization"
  ],
  "data_residency": "US/EU regions",
  "customers": [
    "Diabetes Clinic in Bad Mergentheim, Germany"
  ],
  "user_reviews": [
    "EyeArt has been instrumental in our clinic's workflow, providing rapid and accurate diabetic retinopathy screenings."
  ],
  "ratings": [
    "4.8/5 on G2.com"
  ],
  "support_channels": [
    "email",
    "phone",
    "chat",
    "ticketing",
    "community",
    "24x7"
  ],
  "training_options": [
    "documentation",
    "webinars",
    "live_online",
    "onsite",
    "certification"
  ],
  "release_year": "2018",
  "integration_partners": [
    "Canon CR-2 AF",
    "Canon CR-2 Plus AF",
    "Topcon NW400"
  ],
  "id": "SW0345",
  "slug": "eyeart",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/eyeart.json"
  }
}