LumineticsCore (IDx-DR)
Digital Diagnostics
The first autonomous AI diagnostic device authorized in the United States. Produces a screening result from retinal photographs without a clinician interpreting the image.
At A Glance
- Manufacturer
- Digital Diagnostics
- Medical specialty
- Ophthalmology
- Clearance route
- De Novo
- Year authorized
- 2018
- Modality
- Retinal photography
- Role in workflow
- Autonomous diagnostic
This is the device that made the autonomous category exist. Every other device on this list produces something a clinician then interprets. IDx-DR produces a result, and no physician reads the image. That is a different liability structure, a different validation requirement, and a different regulatory conversation entirely.
It was also validated prospectively at primary care sites with the intended non-specialist staff, rather than retrospectively on curated images, which is still uncommon in this field.
Where It Is Used
- Diabetic retinopathy screening in primary care
- Screening where no ophthalmologist is present
- Closing care gaps in diabetes management
Limitations Worth Knowing
The device screens for more-than-mild diabetic retinopathy and does not assess other retinal pathology. A negative result means the screening indication was not met, not that the eye is normal. Image quality gating means some patients cannot be screened at all and still require referral.
Regulatory status, indications, and labeling change over time. Confirm current status on the FDA's AI/ML-Enabled Medical Devices list and in the manufacturer's current instructions for use before relying on anything stated here.