AEYE-DS

JSON twin: https://www.healthaidb.com/software/aeye-ds.json

Company Name

AEYE Health

Product URL

https://www.aeyehealth.com/aeye-diagnostic-screening

Company URL

https://www.aeyehealth.com

Categories

• diagnostic Support
• clinical Care
• patient Facing
• administrative Operations
• Diagnostic
• Clinical
• Administrative

Summary

AEYE-DS is an AI-powered diagnostic screening solution for diabetic retinopathy, enabling rapid, point-of-care detection using portable retinal cameras.

Description

AEYE-DS, developed by AEYE Health, is an FDA-cleared AI diagnostic system designed for autonomous detection of more-than-mild diabetic retinopathy in adults with diabetes. It operates with portable retinal cameras, requiring only one image per eye and rarely necessitating dilation, providing instant diagnostic results. The system is compatible with Topcon NW400 and Optomed Aurora cameras, facilitating flexible and accessible screening in various healthcare settings. AEYE-DS has demonstrated high sensitivity and specificity in clinical studies, with sensitivity ranging from 92% to 93% and specificity between 89% and 94%, depending on the camera used. The solution is reimbursable under CPT code 92229, addressing care gaps and improving quality metrics such as HEDIS scores and Star ratings. AEYE Health has partnered with organizations like Ford Medical to expand AEYE-DS's availability in pharmacies and non-acute centers, enhancing early detection and treatment of diabetic retinopathy. Additionally, AEYE-DS has been integrated into electronic medical record systems, such as at UMass Memorial Health, to streamline workflows and improve patient outcomes. The system's portability and ease of use make it suitable for home care settings, offering convenient screening options for patients.

Api Available

unknown

Certifications

• FDA 510(k) clearance
• SOC 2 Type II certification

Company Founding

2019

Company Offices

• United States
• Israel

Compliance

• HIPAA
• FDA 510(k) clearance
• SOC 2 Type II certification

Customers

Data Residency

US/EU regions

Data Standards

• FHIR
• HL7 v2
• DICOM
• SNOMED
• ICD-10

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Autonomous diabetic retinopathy screening
• Single image per eye requirement
• Instantaneous diagnostic results
• Portable and cost-effective retinal cameras
• Integration with electronic medical records (EMR)
• FDA-cleared for use with Topcon NW400 and Optomed Aurora cameras
• High sensitivity and specificity in clinical studies
• Dedicated CPT code 92229 for AI diabetic retinopathy screening
• Improvement in diabetic eye care adherence and quality measures

Id

SW0226

Integration Partners

Integrations

• Topcon NW400
• Optomed Aurora
• Electronic Medical Records (EMR) systems

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb
• consumer

Optional Modules

• Handheld device integration
• Robotic tabletop camera integration

Os Platforms

• Web
• iOS
• Android
• Windows
• macOS
• Linux

Pricing Details

contact vendor

Pricing Model

subscription

Privacy Features

• BAA available
• consent management
• anonymization
• data minimization

Product Code

SW0226

Product Name

AEYE-DS

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
• RBAC
• SSO/SAML
• audit logs
• 2FA
• DLP

Specialties

• Diabetic Retinopathy
• Ophthalmology

Support Channels

System Requirements

Topcon NW400 or Optomed Aurora camera, internet connectivity

Target Users

• clinicians
• nurses
• patients
• admins
• payers

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "AEYE-DS",
  "company_name": "AEYE Health",
  "product_url": "https://www.aeyehealth.com/aeye-diagnostic-screening",
  "company_url": "https://www.aeyehealth.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0226",
  "summary": "AEYE-DS is an AI-powered diagnostic screening solution for diabetic retinopathy, enabling rapid, point-of-care detection using portable retinal cameras.",
  "description": "AEYE-DS, developed by AEYE Health, is an FDA-cleared AI diagnostic system designed for autonomous detection of more-than-mild diabetic retinopathy in adults with diabetes. It operates with portable retinal cameras, requiring only one image per eye and rarely necessitating dilation, providing instant diagnostic results. The system is compatible with Topcon NW400 and Optomed Aurora cameras, facilitating flexible and accessible screening in various healthcare settings. AEYE-DS has demonstrated high sensitivity and specificity in clinical studies, with sensitivity ranging from 92% to 93% and specificity between 89% and 94%, depending on the camera used. The solution is reimbursable under CPT code 92229, addressing care gaps and improving quality metrics such as HEDIS scores and Star ratings. AEYE Health has partnered with organizations like Ford Medical to expand AEYE-DS's availability in pharmacies and non-acute centers, enhancing early detection and treatment of diabetic retinopathy. Additionally, AEYE-DS has been integrated into electronic medical record systems, such as at UMass Memorial Health, to streamline workflows and improve patient outcomes. The system's portability and ease of use make it suitable for home care settings, offering convenient screening options for patients.",
  "categories": [
    "diagnostic Support",
    "clinical Care",
    "patient Facing",
    "administrative Operations",
    "Diagnostic",
    "Clinical",
    "Patient-facing",
    "Administrative"
  ],
  "market_segment": [
    "enterprise",
    "smb",
    "consumer"
  ],
  "target_users": [
    "clinicians",
    "nurses",
    "patients",
    "admins",
    "payers"
  ],
  "specialties": [
    "Diabetic Retinopathy",
    "Ophthalmology"
  ],
  "regions_available": [
    "United States"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "subscription",
  "pricing_details": "contact vendor",
  "license": "commercial",
  "company_offices": [
    "United States",
    "Israel"
  ],
  "company_founding": "2019",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "Autonomous diabetic retinopathy screening",
    "Single image per eye requirement",
    "Instantaneous diagnostic results",
    "Portable and cost-effective retinal cameras",
    "Integration with electronic medical records (EMR)",
    "FDA-cleared for use with Topcon NW400 and Optomed Aurora cameras",
    "High sensitivity and specificity in clinical studies",
    "Dedicated CPT code 92229 for AI diabetic retinopathy screening",
    "Improvement in diabetic eye care adherence and quality measures"
  ],
  "optional_modules": [
    "Handheld device integration",
    "Robotic tabletop camera integration"
  ],
  "integrations": [
    "Topcon NW400",
    "Optomed Aurora",
    "Electronic Medical Records (EMR) systems"
  ],
  "data_standards": [
    "FHIR",
    "HL7 v2",
    "DICOM",
    "SNOMED",
    "ICD-10"
  ],
  "api_available": "unknown",
  "system_requirements": "Topcon NW400 or Optomed Aurora camera, internet connectivity",
  "compliance": [
    "HIPAA",
    "FDA 510(k) clearance",
    "SOC 2 Type II certification"
  ],
  "certifications": [
    "FDA 510(k) clearance",
    "SOC 2 Type II certification"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "audit logs",
    "2FA",
    "DLP"
  ],
  "privacy_features": [
    "BAA available",
    "consent management",
    "anonymization",
    "data minimization"
  ],
  "data_residency": "US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0226",
  "slug": "aeye-ds",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/aeye-ds.json"
  }
}