Ophthalmology AI medical devices

A neutral, evidence-based catalogue of ophthalmology AI medical devices. No manufacturer pricing, no buy links — just regulatory facts and clinical capability summaries.

LumineticsCore

Digital Diagnostics (formerly IDx Technologies)

Verified clinician reviews launching

Autonomous deep-learning software that analyses retinal fundus images acquired with a Topcon TRC-NW400 non-mydriatic camera to detect more-than-mild diabetic retinopathy (mtmDR) and clinically significant diabetic macular edema — and issues a binary refer/rescreen result without any physician or optometrist interpreting the image. The algorithm is the first and, to date, only FDA-cleared AI medical device operating entirely without a human-in-the-loop diagnostic step.

EyeArt

Eyenuk

Verified clinician reviews launching

Autonomous AI system that analyses color fundus images to detect more-than-mild and vision-threatening diabetic retinopathy at the point of care.

EyeLook Glaucoma

Digital Diagnostics

Sourced from FDA AI list Ophthalmology

Optomed Aurora IQ

Optomed

Editorial summary Ophthalmology

RetinAI Discovery

RetinAI Medical

Sourced from FDA AI list Ophthalmology

Notal Vision Home Optical Coherence Tomography (OCT) System

Notal Vision Inc

Sourced from FDA AI list Ophthalmology

EyeArt v2.2.0

Eyenuk, Inc.

Sourced from FDA AI list Ophthalmology

CLARUS (700)

Carl Zeiss Meditec, Inc.

Sourced from FDA AI list Ophthalmology

AEYE-DS

AEYE Health Inc.

Sourced from FDA AI list Ophthalmology

AEYE-DS

AEYE Health, Inc.

Sourced from FDA AI list Ophthalmology

IDx-DR v2.3

Digital Diagnostics Inc.

Sourced from FDA AI list Ophthalmology

EyeArt

Eyenuk, Inc

Sourced from FDA AI list Ophthalmology

CLARUS

Carl Zeiss Meditec, Inc

Sourced from FDA AI list