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RetinaLyze

by RetinaLyze

AI Application
Low Confidence

RetinaLyze is cloud software for eye screening, used by optometrists, opticians, eye clinics and hospitals. Retinal photos and OCT scans come in from more than 60 supported cameras and systems; the vendor says a combination of deep learning, convolutional neural networks and rule-based algorithms looks for signs of diabetic retinopathy, glaucoma and age-related macular degeneration and returns a result in about 45 seconds, with overlays and optic-disc measurements such as cup/disc ratio. A yellow alert means further clinical evaluation is recommended and a red alert means referral to an ophthalmologist. The professional adds their clinical judgement to make the final decision, and a built-in telemedicine module lets them consult the vendor's ophthalmologist network or their own and send digital referrals. The vendor says it acts as a data processor, stores images in EU-based cloud storage for as long as the customer is active, and may process data in Denmark and other countries.

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Transparency Score

Weighted across four pillars · updated October 20, 2026

Overall grade
20% weighted
ABCDF
Model
—
Not yet assessed
Infrastructure
—
Not yet assessed

Capabilities

Diabetic Retinopathy Screening
Glaucoma Screening
Amd Screening
Optic Disc Measurement
Telemedicine Referral

Vendor Information

Complete information about the vendor/provider of this AI application

RetinaLyzeView all products →
RetinaLyze System A/S(Trading as: RetinaLyze)
Contact Information
retinalyze.com
Registered Address
Lyskær 1, 3. sal, Herlev, Capital Region of Denmark, 2730, DK

EU AI Act Provider Information

Verification Status:
Unverified
RetinaLyze System A/S(Trading as: RetinaLyze)
Lyskær 1, 3. sal, Herlev, Capital Region of Denmark, 2730, DK
Compliance Documents
CE Marking: Certified
RetinaLyze's FAQ says it does not apply the ICDR, ETDRS or AREDS grading scales and is designed to detect signs of retinal disease rather than replicate manual grading; that its training data come mostly from Scandinavian and European sources; and that it is 'currently transitioning from CE Class I (MDD) to CE Class IIa (MDR)' and is not FDA certified (https://retinalyze.com/faq/, read 2026-10-20). No contraindications are published.
Compliance & Risk

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Added: October 20, 2026
Updated: October 20, 2026

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