RetinaLyze Retinal Screening Software
US$ 18,000 Price in USD — free shipping included
Independent profile. MedikalDevice is not affiliated with its manufacturer. Specifications come from public manufacturer documentation — confirm FDA status for your intended use. How we verify profiles.
Cloud-based AI software (not a camera) that analyzes fundus photographs and OCT scans for signs of diabetic retinopathy, glaucoma and age-related macular degeneration. Used by eye clinics, optometrists, diabetes clinics and GPs outside the US.
Key facts
| Product | RetinaLyze |
|---|---|
| Manufacturer | RetinaLyze System A/S (Denmark) |
| Intended users | Healthcare professionals |
| US FDA status | Not FDA-cleared (wellness/consumer) |
| Market status | Available |
Main features
- Screens for signs of diabetic retinopathy, glaucoma and AMD
- Hardware-agnostic: works with 60+ fundus camera and OCT brands
- Explainable results with image overlays
- Telemedicine messaging and digital referral (PACS/EHR integration)
- Glaucoma progression module
Connectivity
Web/cloud upload or direct integration with camera/OCT and software partners.
AI and analysis software
RetinaLyze AI analysis of fundus/OCT images (DR, glaucoma, AMD); Advanced Glaucoma Progression AI.
Software outputs are an aid to the clinician, not a diagnosis, and are limited to the indications cleared for each feature.
Regulatory status in the United States
We found no FDA clearance or approval for this product. It should not be relied on for diagnosis in the United States. Not FDA-cleared and not available in the US (per manufacturer); CE-marked, moving from Class I (MDD) to Class IIa (MDR).
Related guide: Medical Device AI Built-In vs Medical Cloud AI vs Medical Device Hybrid.
Sources
- retinalyze.com (manufacturer)
- retinalyze.com
- glance.eyesoneyecare.com
Profile verified against public sources in October 2026. Trademarks belong to their owners.
