LumineticsCore (Formerly IDx-DR)

LumineticsCore is the current name of the autonomous diabetic retinopathy system first authorized as IDx-DR. It is intended for adults age 22 or older who have diabetes, have not previously been diagnosed with diabetic retinopathy, and are not already under the care of an eye specialist.

What Happens During The Screening

1. A trained user captures two retinal images per eye with the compatible Topcon NW400 camera.
2. The system checks the images and analyzes them for more-than-mild diabetic retinopathy.
3. It returns a result during the visit. A positive result leads to referral; a negative result leads to repeat screening under the current instructions.

The distinction is autonomy. The system returns the result for its stated indication without a physician or eye specialist interpreting the images first.

Where It Fits

The device is designed for point-of-care settings such as primary care, where diabetic eye screening can happen during the same visit as other diabetes care. That makes the referral step part of the implementation, not an afterthought.

Current Product Sources

Digital Diagnostics publishes the current LumineticsCore indication and workflow. The FDA's AI-Enabled Medical Device List links to the authorization record.