IDx-DR
Overview
About IDx-DR (now LumineticsCore®)
IDx-DR, now known as LumineticsCore®, is a pioneering autonomous artificial intelligence (AI) diagnostic system developed by Digital Diagnostics. It is designed to automatically detect more-than-mild diabetic retinopathy (mtmDR) in adults (22 years of age or older) who have been diagnosed with diabetes and have not been previously diagnosed with diabetic retinopathy.
The system operates by analyzing two 45-degree fundus images per eye (one macula-centered and one optic disc-centered) captured by a trained operator using a Topcon NW400 non-mydriatic fundus camera, often without the need for pupil dilation. These images are submitted to a secure, cloud-based AI algorithm that processes them within minutes, providing a rapid diagnostic report.
LumineticsCore® delivers one of three possible outcomes: exam quality insufficient, negative for more than mild diabetic retinopathy (retest in 12 months), or more than mild diabetic retinopathy detected (refer to an eye care professional). A key feature is its autonomous nature, meaning that for negative results, no physician overread is required, enabling frontline care providers to offer specialty-level diagnostics in primary care settings.
The system aims to increase patient access to early disease detection, improve compliance with annual diabetic eye screenings, and reduce the diagnostic burden on specialists, ultimately helping to prevent vision loss due to diabetic retinopathy.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Autonomous AI diagnostic system for mtmDR detection
- Uses Topcon NW400 non-mydriatic fundus camera for image acquisition
- Provides rapid diagnostic results within minutes
- No physician overread required for negative screening results
- Cloud-based AI algorithm for image analysis
- High sensitivity (87%) and specificity (90%) for mtmDR detection
- Outputs results in JPG, PDF, and XML formats
- Includes clear follow-up instructions for patient care
- Robust cybersecurity measures for data protection
- Designed for integration into existing clinical workflows
Use Cases
- Diabetic retinopathy screening in primary care settings
- Increasing access to annual diabetic eye exams
- Early detection of diabetic retinopathy to prevent vision loss
- Reducing diagnostic burden on ophthalmology specialists
- Improving patient compliance with recommended screenings
- Supporting teleophthalmology programs for remote diagnosis
What Physicians Need to Know
IDx-DR (LumineticsCore) is an autonomous AI system specifically for screening more than mild diabetic retinopathy (mtmDR) in adults with diabetes who have no prior DR diagnosis. It's crucial to remember it does not screen for other ocular conditions like glaucoma or AMD. For positive results or ungradable images, immediate referral to an eye care professional is essential. The system requires images from a Topcon TRC-NW400 camera, and proper image acquisition is vital for accurate results. Integrate this tool to enhance DR screening rates in primary care, but always counsel patients on its specific diagnostic scope and the importance of follow-up care.
IDx-DR operates as a cloud-based software that analyzes fundus images captured by the Topcon TRC-NW400 camera. It is designed to integrate into existing clinical workflows, including teleophthalmology programs and electronic health record (EHR) systems, to streamline the screening process. Results are generated rapidly, enabling real-time decision-making at the point of care.
Details
| Category | Ophthalmology AI |
| Pricing |
Contact for pricing
|
| Deployment | Cloud-based software with a local client application for image acquisition. |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated IDx-DR received De Novo clearance (DEN180001) from the FDA in April 2018 as the first autonomous AI diagnostic system for detecting more-than-mild diabetic retinopathy (mtmDR) in adults (22 years or older) diagnosed with diabetes who have not been previously diagnosed with DR, for use with the Topcon NW400 fundus camera. A subsequent 510(k) clearance (K213037) was granted on June 17, 2022, for an updated version (v2.3) of the system. |
| Integrations | |
| EHR | Not specified |
| Specialties | Endocrinology, Internal Medicine, Ophthalmology |
What the Web Says
IDx-DR, now known commercially as LumineticsCore or AEye (Optomed), is the first FDA-authorized autonomous AI diagnostic system for detecting more-than-mild diabetic retinopathy (DR) in adults with diabetes. It analyzes retinal images captured by a fundus camera, providing a diagnosis without requiring a clinician to interpret the images. This technology aims to increase access to DR screening, particularly in primary care settings where ophthalmologists may not be readily available.
Overall: PositiveStrengths
- Autonomous AI diagnosis reduces reliance on specialist availability and enables early intervention.
- Increases access to diabetic retinopathy screening in primary care settings.
- Can be operated by staff with minimal training (e.g., four hours), making it scalable and cost-effective.
- Provides rapid results (within minutes), allowing for immediate referral if needed.
- High sensitivity and specificity for detecting more-than-mild DR, with reported sensitivity around 87-94% and specificity around 89-90%.
- Overestimates disease severity more often than it underestimates, which is considered a safer error for a screening device.
Limitations
- Only detects diabetic retinopathy; it does not diagnose other eye diseases and does not replace a comprehensive ophthalmologic examination.
- Requires specific compatible fundus camera hardware, which can be an additional investment for healthcare settings.
- Positive findings still require ophthalmologist follow-up for in-person evaluation and treatment planning.
- Can have a substantial number of false positives, particularly in classifying mild DR, potentially leading to unnecessary referrals.
- Requires high-quality retinal images; blurred or poorly illuminated images can impact accuracy, and a significant percentage of images may be unanalyzable.
- Less effective at detecting earlier stages of the disease compared to severe cases.
Based on reviews from: SmarterWay.AI, FDA, Review of Optometry, Review of Ophthalmology, Retinal Physician, PMC (Real-world performance of the AI diagnostic system IDx-DR), accessdata.fda.gov, AAFP, PMC (Accuracy of Autonomous Artificial Intelligence-Based Diabetic Retinopathy Screening), American Medical Association, MedCity News, Optometry Times, University of Iowa Health Care, American Academy of Ophthalmology, AI News Trends, Reddit (r/medicine, r/Ophthalmology), G2, Capterra, PubMed, Xtalks, Retina Specialist
Last updated: 2026-07-21
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