EyeArt

By Eyenuk
· USA
Eyenuk — Autonomous diabetic retinopathy screening, across multiple camera models.
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, across multiple camera models.

Regulatory status

FDA cleared as an autonomous system; recent extension to multiple compatible camera models.

Clinical evidence

Vendor-supported

Vendor press release for the multi-camera clearance.

Independent

Not found in this research pass — verify before publishing.

Real-world deployment

Not quantified in this research pass.

Interoperability

European status

Editorial verdict

Limits and uncertainties

No independent evidence found in this pass; autonomous-tool accountability model needs explicit explanation.

Sources

https://www.prnewswire.com/news-releases/new-fda-clearance-makes-eyenuk-the-first-company-with-multiple-cameras-for-autonomous-ai-detection-of-diabetic-retinopathy-301857717.html

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
Eyenuk
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.