JSON twin: https://www.healthaidb.com/software/digital-diagnostics-lumineticscore.json
Digital Diagnostics
https://www.digitaldiagnostics.com/products/eye-disease/lumineticscore/
https://www.digitaldiagnostics.com
FDA‑cleared autonomous AI system that analyzes retinal images at point-of-care to detect more‑than‑mild diabetic retinopathy (including diabetic macular edema).
LumineticsCore (formerly IDx-DR) is a proprietary, FDA De Novo–cleared autonomous diagnostic AI that evaluates fundus images to identify more‑than‑mild diabetic retinopathy (mtmDR) including macular edema without requiring specialist interpretation; designed for use in primary care, eye care, and other clinical settings to increase screening access and provide an on‑site diagnostic result integrated into provider workflow.
unknown
2010
P0474
2025-09-07
commercial proprietary
Contact vendor for pricing, deployment and subscription details; commercial/enterprise sales and training available.
enterprise_quote
2018
Requires operator-captured fundus camera images (Topcon NW400 indicated); web browser access to vendor portal
product
1.0
{
"company_name": "Digital Diagnostics",
"company_url": "https://www.digitaldiagnostics.com",
"company_offices": [
"United States"
],
"company_founding": "2010",
"product_url": "https://www.digitaldiagnostics.com/products/eye-disease/lumineticscore/",
"categories": [
"diagnostic",
"clinical",
"imaging",
"AI/machine learning",
"screening",
"ophthalmology",
"point-of-care"
],
"market_segment": [
"enterprise",
"healthcare providers",
"payors"
],
"links": [
"https://www.digitaldiagnostics.com",
"https://www.digitaldiagnostics.com/products/eye-disease/lumineticscore/",
"https://www.digitaldiagnostics.com/products/eye-disease/indications-for-use-us/",
"https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180001.pdf",
"https://www.digitaldiagnostics.com/resources/papers-and-trials/lumineticscore-formerly-known-as-idx-dr-pivotal-trial/",
"https://www.digitaldiagnostics.com/fda-permits-marketing-of-lumineticscore-formerly-known-as-idx-dr-for-automated-detection-of-diabetic-retinopathy-in-primary-care/",
"https://www.digitaldiagnostics.com/contact/get-support/",
"https://www.linkedin.com/company/digital-diagnostics",
"https://www.prnewswire.com/news-releases/digital-diagnostics-sheds-light-on-ai-tech-with-lumineticscore-product-rebrand-301782573.html"
],
"summary": "FDA‑cleared autonomous AI system that analyzes retinal images at point-of-care to detect more‑than‑mild diabetic retinopathy (including diabetic macular edema).",
"description": "LumineticsCore (formerly IDx-DR) is a proprietary, FDA De Novo–cleared autonomous diagnostic AI that evaluates fundus images to identify more‑than‑mild diabetic retinopathy (mtmDR) including macular edema without requiring specialist interpretation; designed for use in primary care, eye care, and other clinical settings to increase screening access and provide an on‑site diagnostic result integrated into provider workflow.",
"target_users": [
"primary care clinicians",
"optometrists",
"ophthalmologists",
"nurses/medical assistants",
"clinic administrators"
],
"specialties": [
"ophthalmology",
"optometry",
"primary care",
"endocrinology/diabetes care"
],
"regions_available": [
"United States"
],
"languages_supported": [
"English"
],
"pricing_model": "enterprise_quote",
"pricing_details": "Contact vendor for pricing, deployment and subscription details; commercial/enterprise sales and training available.",
"license": "commercial proprietary",
"deployment_model": [
"SaaS",
"point-of-care"
],
"os_platforms": [
"Web"
],
"features": [
"Autonomous AI diagnosis of diabetic retinopathy (includes 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": [
"SphereDx (securely hosted diagnostic results service)"
],
"integrations": [
"Topcon NW400",
"Epic"
],
"data_standards": [],
"api_available": "unknown",
"system_requirements": "Requires operator-captured fundus camera images (Topcon NW400 indicated); web browser access to vendor portal",
"compliance": [
"HIPAA"
],
"certifications": [
"FDA De Novo clearance (K213037)",
"ISO 13485:2016"
],
"security_features": [
"Securely hosted diagnostic results (SphereDx)"
],
"privacy_features": [
"Notice of Privacy Practices (patient privacy page)"
],
"data_residency": "",
"customers": [
"OSF Healthcare",
"OCHIN",
"Marshall Health",
"Tarzana Treatment Centers",
"Johns Creek Primary Care",
"Cahaba Medical Care",
"Baxter"
],
"user_reviews": [],
"ratings": [],
"support_channels": [
"email (support@digitaldiagnostics.com)",
"phone",
"help center / ticketing"
],
"training_options": [
"documentation",
"webinars",
"live_online",
"onsite",
"customer success representative"
],
"release_year": "2018",
"integration_partners": [
"Baxter",
"OCHIN",
"OSF Healthcare",
"Marshall Health"
],
"id": "P0474",
"slug": "digital-diagnostics-lumineticscore",
"type": "product",
"version": "1.0",
"last_updated": "2025-09-07",
"links_json": {
"self": "https://www.healthaidb.com/software/digital-diagnostics-lumineticscore.json"
}
}