LumineticsCore

By Digital Diagnostics
· USA
Digital Diagnostics — Autonomous diabetic retinopathy screening from retinal imaging.
Diagnostic
Ophthalmology
Production
FDA Cleared
Regulatory status
FDA Cleared
Deployment
Production
Clinical role
Autonomous (decision without systematic review)
Headquarters
USA
AI type
Diagnostic

Precise indication

Autonomous diabetic retinopathy screening from retinal imaging.

Regulatory status

First FDA-authorized fully autonomous AI diagnostic system across any medical specialty.

Clinical evidence

Vendor-supported

Vendor press release citing growth and named primary-care deployment (OSF HealthCare).

Independent

Named deployment site (OSF HealthCare) is real and identifiable, though the growth figures cited are vendor-reported.

Real-world deployment

Documented primary-care deployment (e.g. OSF HealthCare); vendor claims rapid growth without an independently audited total.

Interoperability

European status

Editorial verdict

Limits and uncertainties

As a fully autonomous diagnostic tool, the clinical accountability model (no physician second read) must be explained clearly on the public profile.

This profile is not medical advice or an endorsement. Hospitals should perform their own due diligence (regulatory compliance, GDPR, cybersecurity, integration, local clinical validation). How we evaluate

At a glance
Vendor
Digital Diagnostics
Headquarters
USA
AI type
Diagnostic
Specialty
Clinical role
Autonomous (decision without systematic review)
CE marking
Notified body
EU AI Act
Data hosting
Last verified
Reviewed by
How we evaluate

Every profile documents the precise indication, regulatory status, vendor-supported and independent evidence, real-world deployment, limits and dated sources.

A independent systematic review or prospective multicentre study · B at least one independent peer-reviewed study · C peer-reviewed, vendor-supported · D vendor claims only.

Read the methodology →

Spotted an error?

Vendors, authors and clinicians can request a correction. Corrections are dated on the profile.