Description
LumineticsCore is an autonomous AI diagnostic system made by Digital Diagnostics, previously sold under the name IDx-DR. It was the first AI system to receive FDA clearance to produce a diagnosis without a physician reviewing the image, and it is built to run inside a primary care visit rather than requiring a referral to an eye specialist.
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A trained operator captures two fundus images of each eye with a compatible fundus camera and submits them to LumineticsCore. The algorithm checks the images for signs of diabetic retinopathy and returns a result within about 30 seconds. If it finds no more than mild diabetic retinopathy, the patient is scheduled to retest in 12 months; if it detects more than mild disease, the system recommends referral to an eye care professional.
In its pivotal clinical trial, Digital Diagnostics reports that LumineticsCore avoided 91% of unnecessary specialty referrals by correctly identifying patients who tested negative for disease at the point of care. The company also states the system was trained and validated to work consistently across sex, race and ethnicity.
LumineticsCore is reimbursable in the US under CPT code 92229, and Digital Diagnostics positions it as a way to close the diabetic eye exam care gap tracked in HEDIS and MIPS quality measures and Medicare Star ratings. Because the exam happens at the point of care, it is aimed at primary care and community health settings that lack easy access to ophthalmology or telemedicine reads.
Digital Diagnostics, founded on research by Michael Abramoff, MD, PhD, also offers SphereDx, a hosted system for storing diagnostic results, and dedicated training for staff who operate the Luminetics product line. Customers cited by the company include primary care and community clinics such as Tarzana Treatment Centers. The company publishes FAQs and product training resources for clinics adopting LumineticsCore for the first time, alongside research papers and clinical trial data supporting its accuracy claims.
- CategoryMedical & Clinical AI
- Pricing ModelPaid
- DeploymentCloud
- PlatformsWeb
LumineticsCore's Core Features
Autonomous diagnosis that produces a result without a physician reviewing the image
Point-of-care testing during a routine primary care visit using two fundus photos per eye
Result returned within about 30 seconds of image submission
First AI system cleared by the FDA for autonomous diagnosis
Reimbursable in the US under CPT code 92229
Referral routing: refers positive mtmDR cases, schedules a 12-month retest for negative cases
Validated across sex, race and ethnicity to reduce bias
Optional integration with Digital Diagnostics' hosted SphereDx results system
How to use LumineticsCore?
Capture images: A trained operator takes two fundus photos of each eye with a compatible camera.
Submit for analysis: The images are sent to LumineticsCore for processing.
Get a result: The system returns a diagnosis within about 30 seconds.
Act on the result: Patients with more than mild diabetic retinopathy are referred to an eye care professional; others are scheduled to retest in 12 months.
Store the record: Diagnostic results can be kept in Digital Diagnostics' SphereDx hosting system.
LumineticsCore's Use Cases
- Primary care screening
- Specialist referral triage
- Care gap closure
