LumineticsCore

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

Company Name

Digital Diagnostics

Product URL

https://www.digitaldiagnostics.com/products/

Company URL

https://www.digitaldiagnostics.com

Categories

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

Summary

LumineticsCore® is an FDA-cleared AI diagnostic system that autonomously detects diabetic retinopathy, including macular edema, at the point-of-care, enhancing early diagnosis and treatment accessibility for individuals with diabetes.

Description

LumineticsCore® is an AI-driven diagnostic platform developed by Digital Diagnostics to identify diabetic retinopathy and macular edema in patients with diabetes. It operates autonomously, analyzing retinal images to provide diagnostic results without the need for specialist interpretation, thereby facilitating early detection and intervention. The system has been integrated into various healthcare settings, including primary care offices and lab service centers, to improve access to eye care for diabetic patients. It has been validated through extensive clinical trials to ensure accuracy and patient safety. The rebranding from IDx-DR to LumineticsCore® reflects the company's mission to make AI diagnostics more approachable and human-centric.

Api Available

unknown

Certifications

• FDA De Novo clearance (K213037)
• ISO 13485:2016

Company Founding

2018

Company Offices

• United States

Compliance

• HIPAA

Customers

Data Residency

US/EU regions

Data Standards

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

Deployment Model

• SaaS
• point-of-care

Features

• Autonomous AI diagnosis of diabetic retinopathy (including macular edema)
• Point-of-care retinal image analysis
• Rapid results at time of encounter (typically seconds)
• Guided high-quality fundus image capture workflow for operators
• FDA De Novo clearance (first autonomous AI diagnostic for DR)
• Works with standard fundus cameras/retinal imaging
• Provides binary output (mtmDR detected/not detected) and referral recommendation
• Designed for use by non-eye care providers in primary care settings
• Supports care gap closure for diabetes eye exams
• Deployed in health systems and ambulatory settings
• Regulatory and compliance support (HIPAA)
• Customer training and implementation services

Id

SW0422

Integration Partners

Integrations

• Topcon NW400
• Epic

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb
• consumer

Optional Modules

Os Platforms

• Web

Pricing Details

contact vendor

Pricing Model

subscription

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization

Product Code

SW0422

Product Name

LumineticsCore

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

Specialties

• Diabetic Retinopathy
• Macular Edema

Support Channels

System Requirements

Target Users

• clinicians
• patients
• admins

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "LumineticsCore",
  "company_name": "Digital Diagnostics",
  "product_url": "https://www.digitaldiagnostics.com/products/",
  "company_url": "https://www.digitaldiagnostics.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0422",
  "summary": "LumineticsCore® is an FDA-cleared AI diagnostic system that autonomously detects diabetic retinopathy, including macular edema, at the point-of-care, enhancing early diagnosis and treatment accessibility for individuals with diabetes.",
  "description": "LumineticsCore® is an AI-driven diagnostic platform developed by Digital Diagnostics to identify diabetic retinopathy and macular edema in patients with diabetes. It operates autonomously, analyzing retinal images to provide diagnostic results without the need for specialist interpretation, thereby facilitating early detection and intervention. The system has been integrated into various healthcare settings, including primary care offices and lab service centers, to improve access to eye care for diabetic patients. It has been validated through extensive clinical trials to ensure accuracy and patient safety. The rebranding from IDx-DR to LumineticsCore® reflects the company's mission to make AI diagnostics more approachable and human-centric.",
  "categories": [
    "diagnostic Support",
    "clinical Care",
    "patient Facing",
    "Diagnostic",
    "Clinical",
    "Patient-facing"
  ],
  "market_segment": [
    "enterprise",
    "smb",
    "consumer"
  ],
  "target_users": [
    "clinicians",
    "patients",
    "admins"
  ],
  "specialties": [
    "Diabetic Retinopathy",
    "Macular Edema"
  ],
  "regions_available": [
    "United States"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "subscription",
  "pricing_details": "contact vendor",
  "license": "commercial",
  "company_offices": [
    "United States"
  ],
  "company_founding": "2018",
  "deployment_model": [
    "SaaS",
    "point-of-care"
  ],
  "os_platforms": [
    "Web"
  ],
  "features": [
    "Autonomous AI diagnosis of diabetic retinopathy (including macular edema)",
    "Point-of-care retinal image analysis",
    "Rapid results at time of encounter (typically seconds)",
    "Guided high-quality fundus image capture workflow for operators",
    "FDA De Novo clearance (first autonomous AI diagnostic for DR)",
    "Works with standard fundus cameras/retinal imaging",
    "Provides binary output (mtmDR detected/not detected) and referral recommendation",
    "Designed for use by non-eye care providers in primary care settings",
    "Supports care gap closure for diabetes eye exams",
    "Deployed in health systems and ambulatory settings",
    "Regulatory and compliance support (HIPAA)",
    "Customer training and implementation services"
  ],
  "optional_modules": [],
  "integrations": [
    "Topcon NW400",
    "Epic"
  ],
  "data_standards": [
    "FHIR",
    "HL7 v2",
    "DICOM",
    "SNOMED",
    "ICD-10"
  ],
  "api_available": "unknown",
  "system_requirements": "",
  "compliance": [
    "HIPAA"
  ],
  "certifications": [
    "FDA De Novo clearance (K213037)",
    "ISO 13485:2016"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "Audit logs",
    "2FA"
  ],
  "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": "SW0422",
  "slug": "lumineticscore",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/lumineticscore.json"
  }
}