This company develops FDA-cleared artificial intelligence diagnostic platforms designed to automate medical diagnosis. Their core product, LumineticsCore, provides autonomous diagnosis for diabetic retinopathy at the point-of-care, improving patient access and quality of care. The platform aims to enhance healthcare affordability and efficiency by delivering rapid, actionable diagnostic results without immediate physician input.
Funding
$75M raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
KKFounders
Product
Problem
Patients with diabetes often lack timely access to specialist eye examinations, leading to delayed detection of diabetic retinopathy—a leading cause of preventable blindness. Traditional screening requires referral to ophthalmology, creating care gaps and increasing costs for health systems.
Solution
Digital Diagnostics’ LumineticsCore® is an FDA‑cleared, autonomous AI diagnostic platform that analyzes fundus images at the point‑of‑care and delivers a definitive diabetic retinopathy assessment without physician overread. The system integrates with standard retinal cameras (e.g., Topcon NW400) and connects to electronic health records via FHIR APIs, enabling results to be recorded instantly during the patient visit. Diagnostic inference is performed in under 30 seconds, supporting immediate referral decisions and closing the annual eye‑exam care gap. The workflow is reimbursable through CPT code 92229, and the cloud‑hosted analytics suite provides longitudinal trend tracking, quality‑measure reporting, and bias‑mitigation monitoring. By embedding high‑accuracy AI into primary‑care and specialty settings, LumineticsCore® expands screening capacity, reduces unnecessary specialist visits, and improves population‑level vision outcomes.
Target Audience
Primary users are primary‑care clinics, urgent‑care centers, and health‑system outpatient sites seeking on‑site diabetic eye screening, as well as ophthalmology and optometry practices that require rapid triage of diabetic retinopathy cases. Payors and accountable‑care organizations also benefit from the cost‑saving and quality‑measure improvements.
Features
- FDA De Novo‑cleared autonomous AI algorithm that detects more than mild diabetic retinopathy (ETDRS ≥ 35) with clinically validated sensitivity and specificity.
- End‑to‑end point‑of‑care workflow: fundus image capture, secure upload, AI inference, and result delivery in <30 seconds.
- Seamless EHR integration via FHIR‑compatible APIs (e.g., EPIC) for automatic result documentation and referral routing.
- CPT 92229 billing enablement for per‑test reimbursement and cost‑effective scaling.
- Bias‑aware model training and validation across sex, race, and ethnicity to ensure equitable performance.
- HIPAA‑compliant data encryption, role‑based access controls, and optional SphereDx™ hosted result storage.
- Cloud‑based analytics dashboard with longitudinal patient trends, HEDIS/MIPS quality metric tracking, and customizable alerts.
- Comprehensive training and support package, including certification modules and on‑site implementation assistance.