Ophthalmology

EyeArt

Eyenuk

FDACE

Clinical Pulse

Verified clinician sentiment

Verified clinician reviews launching · Apply to contribute →

Reviews are signed by clinicians verified against their regulator's public register.

Inside the Auris+ Listing

Six more sections complete this device’s Auris+ Listing.

  • Inside the algorithm

    Pro

    Pro unlocks the five-stage editorial walkthrough of how this device's AI reaches a verdict — model architecture, training data, inference latency, and where the clinician stays in the loop.

  • Decision Ledger

    Pro

    Pro unlocks a private, cross-vendor log of every case you read on this device — what the AI called, what you concluded, and a one-line reason if you overrode it. Ready for the EU AI Act's deployer logging obligations when they land in 2028.

  • Clinical Evidence Deep Dive

    Pro

    Pro unlocks the structured clinical-evidence summary — study count, target patient population, and a tabular accuracy-metrics view drawn from peer-reviewed sources.

  • Peer-Reviewed Publications

    Pro

    Pro unlocks the curated peer-reviewed publication list with PubMed cross-links — the citation backbone of every editorial verdict.

  • Post-Market & Regulatory Conditions

    Pro

    Pro unlocks the post-market surveillance summary, recall record, and the conditions of approval that bound real-world use.

  • AI Algorithm Version History

    Pro

    Pro unlocks the chronological record of algorithm version changes — what changed when, drawn from manufacturer changelogs and regulatory filings.

Upgrade to Pro →

Regulatory Approvals

FDA
US FDA 510k

K200667

CE
EU CE MDR

Safety Record

No safety alerts or recalls on record.