Medical imaging and radiology
Eyenuk EyeArt
FDA-cleared autonomous diabetic retinopathy screening system that analyzes retinal images and returns patient-level and eye-level screening results.
Last updated: June 14, 2026
Back to directoryLumineticsCore medical AI product profile
FDA De Novo-cleared autonomous diagnostic AI for detecting more-than-mild diabetic retinopathy in eligible adults with diabetes.
Medical imaging and radiology
Best fit
Primary-care or diabetes-care settings that need point-of-care diabetic eye exam workflows with defined referral instructions.
- Primary use case
- Autonomous AI diabetic retinopathy detection from retinal images at the point of care
- Audience
- Primary care, diabetes care, ophthalmology referral networks, and health systems
- Risk level
- High
- Pricing signal
- Provider deployment pricing; request current terms and reimbursement workflow.
- Official sources
- 5 official sources
Compare within workflow: Medical imaging and radiology · comparison shortlist · source index
Regulatory snapshot
| Status | FDA De Novo authorized autonomous diagnostic system, originally IDx-DR and now marketed as LumineticsCore. |
|---|---|
| Review route | De Novo DEN180001. |
| Intended use | Automatically detects more-than-mild diabetic retinopathy in adults with diabetes who have not previously been diagnosed with diabetic retinopathy, using the specified retinal camera workflow. |
| Verification note | Confirm the current label, camera requirement, contraindications, operator training, image-quality exclusions, and referral instructions before primary-care deployment. |
| Source | www.accessdata.fda.gov / cdrh_docs / reviews |
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating LumineticsCore as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Because this is positioned as autonomous diagnostic AI, match use exactly to the FDA-cleared indications, contraindications, trained operators, Topcon camera requirement, and required workflow. |
|---|---|
| Privacy | Review retinal-image capture, device connectivity, diagnostic-result hosting, storage, access controls, report delivery, referral communication, and patient-consent documentation. |
| Evidence | Monitor unreadable-image rates, false positives, false negatives, referral completion, and local prevalence instead of relying only on clearance status. |
| Workflow | Best suited to protocolized diabetic-eye-exam workflows with defined eligibility screening, patient instructions, referral routing, billing, and quality oversight. |
Where LumineticsCore fits
Digital Diagnostics describes LumineticsCore as an autonomous AI diagnostic system for more-than-mild diabetic retinopathy in adults with diabetes, with FDA De Novo clearance, device-specific indications, contraindications, warnings, camera requirements, and point-of-care workflow controls.
Not for: Full eye exams, use outside the cleared patient population, or diabetic-retinopathy diagnosis without trained operators and device-specific workflow controls.
What to verify before using LumineticsCore
- FDA De Novo authorization, indications for use, contraindications, and exact eligible patient population.
- Required camera, image-quality workflow, operator training, and referral process.
- How results are documented, billed, and communicated to patients and eye-care providers.
- Local performance monitoring for unreadable images, false positives, false negatives, and follow-up completion.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- www.digitaldiagnostics.com / products / eye-disease
- www.digitaldiagnostics.com / products / eye-disease
- www.digitaldiagnostics.com / newsroom / fda-permits-marketing-of-lumineticscore-formerly-known-as-idx-dr-for-automated-detection-of-diabetic-retinopathy-in-primary-care
- www.digitaldiagnostics.com / privacy-policy
- www.accessdata.fda.gov / cdrh_docs / reviews
Related medical AI products
Medical imaging and radiology
AEYE-DS
FDA-cleared autonomous AI diagnostic screening system for more-than-mild diabetic retinopathy in eligible adults with diabetes.
Medical imaging and radiology
RETINA-AI Galaxy
FDA-cleared autonomous diabetic retinopathy screening software for moderate-or-worse diabetic retinopathy using supported robotic fundus cameras.
Medical imaging and radiology
RetInSight Fluid Monitor
CE-marked Class IIa clinical decision-support software that quantifies retinal fluid biomarkers in OCT scans for neovascular age-related macular degeneration monitoring.