Fully autonomous diagnosis without specialist interpretation

LumineticsCore analyzes retinal images and provides a diagnostic result — referable or non-referable diabetic retinopathy — without requiring a specialist to review the images. This is the core differentiator from other AI healthcare tools that only assist specialists.

Business outcome: Eliminates the specialist bottleneck, enabling same-visit screening in primary care.

First FDA-cleared autonomous AI for diabetic retinopathy

LumineticsCore received FDA De Novo classification, making it the first AI system authorized to make a screening decision independently. This regulatory milestone provides confidence for healthcare organizations adopting AI-driven diagnostics.

Business outcome: Reduces regulatory risk and accelerates adoption in clinical settings.

Works with existing fundus cameras

The platform integrates with standard retinal cameras already used in clinics. No need to purchase new imaging hardware — LumineticsCore processes images from compatible devices and returns results directly.

Business outcome: Minimizes capital expenditure and leverages existing equipment investments.

Results in under one minute

After image capture, LumineticsCore delivers a diagnostic result within 60 seconds. This speed enables same-visit care decisions — patients know their status before leaving the clinic.

Business outcome: Improves patient experience and reduces follow-up visits for screening results.

Deployable across multiple clinic sites

LumineticsCore is designed for distributed deployment. Health systems can standardize screening protocols across primary care clinics, optometry practices, and telemedicine networks using a single AI platform.

Business outcome: Enables consistent screening quality and centralized oversight across a health system.

Embedded in existing clinical workflows

The system is designed to fit into the standard patient visit flow — image capture during the exam, AI analysis, and immediate result documentation in the EHR. Minimal training required for staff.

Business outcome: Low adoption friction and minimal disruption to clinic operations.

• First-mover regulatory advantageFDA clearance for autonomous diagnosis provides a significant trust and compliance edge over unregulated AI screening tools.
• Specialist-free workflowEliminates the need for ophthalmologist or optometrist image review, freeing specialists for complex cases.
• Real-time resultsSame-visit diagnosis improves patient adherence and reduces the administrative burden of follow-up appointments.
• Proven clinical validationPublished studies demonstrate sensitivity and specificity comparable to specialist graders, supporting clinical adoption.

• Single condition focusLumineticsCore screens only for diabetic retinopathy — it does not detect other eye diseases like glaucoma or cataracts.
• Image quality dependencyThe system requires adequate-quality retinal images; poor image capture may lead to inconclusive results requiring retakes.
• No public pricingCost transparency is limited — organizations must engage in a sales process to understand total cost of ownership.
• Professional RealityLumineticsCore is a screening tool, not a diagnostic replacement for a comprehensive eye exam — patients with positive results still need specialist follow-up.

Primary care clinic screening program

A community health center integrates LumineticsCore into annual diabetic wellness visits. Patients get screened during the appointment, and those with referable retinopathy are scheduled for ophthalmology. The clinic reduces specialist referral wait times by 70%.

Health system standardization

A large health system deploys LumineticsCore across 20 primary care clinics. Standardized AI screening ensures consistent quality, and centralized analytics help identify high-risk patient populations for proactive care management.

Telemedicine diabetic eye care

A telemedicine provider uses LumineticsCore to offer remote diabetic retinopathy screening. Patients capture retinal images at partner clinics, and AI analysis is performed remotely — expanding access to rural and underserved areas.

Optometry practice efficiency

An optometry practice adds LumineticsCore to routine exams. The AI handles diabetic retinopathy screening, allowing optometrists to focus on complex cases and patient counseling. Practice throughput increases by 30%.

Assess your current retinal imaging equipment — LumineticsCore integrates with most fundus cameras; confirm compatibility.

Contact Digital Diagnostics for a pricing consultation and demo tailored to your clinic volume and setting.

Train clinical staff on image capture protocol — the system requires minimal training, typically a few hours.

Integrate LumineticsCore into your EHR workflow for seamless result documentation and patient follow-up.