RetinaLyze

by RetinaLyze System A/S  · Based in Denmark → — Faster, safer eye screenings
Ophthalmology
Website
Claim this tool
Is this the maker? Claim the company →

Contact sales

Overview

RetinaLyze is an AI-powered software solution designed to assist eye care professionals in performing faster and safer screenings for signs of pathology such as diabetic retinopathy, AMD, and glaucoma. It leverages AI algorithms to analyze retinal images and OCT scans, providing instant, easy-to-understand results within 45 seconds. The system integrates with over 60 device and software partners, automating the workflow of image transfer and result delivery. It functions as a clinical decision support system (CDSS) or a screening tool, incorporating built-in telemedicine capabilities for communication with ophthalmologists and digital referrals. RetinaLyze is designed to support compliance with data protection and medical device regulations, having performed over 7 million screenings since its inception in 2013.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI analysis of retinal images and OCT scans for pathology detection (Diabetic Retinopathy, AMD, Glaucoma)
  • Instant results (30-45 seconds for fundus/OCT images)
  • Integrations with 60+ device and software partners for automated workflow
  • Explainable AI overlays and extraction of measurements (e.g., cup/disc ratio, disc area)
  • Built-in telemedicine for communication with ophthalmologists and expert backup
  • Digital referral capabilities with PACS/EHR integration and clear PDF reports
  • Functions as a Clinical Decision Support System (CDSS)
  • Compliance with EU GDPR, EU AI Act, UK MHRA, ISO 13485, Brazil LGPD, Brazil ANVISA, EU CE
  • Historical image comparison and progression tracking (e.g., Glaucoma Index of Progression - GIP)
  • Web-based access and user-friendly interface with multi-language support

Use Cases

  • Enabling optometrists to offer solid eye health services with value-add, compliance, and operational efficiency
  • Increasing efficiency in hospitals/clinics by offloading routine screening tasks from eye specialists to nurses
  • Improving quality of screening and ensuring timely and accurate referrals to ophthalmologists
  • Facilitating tele-ophthalmology and remote expert assessment of retinal images and OCT scans
  • Streamlining workflow for retinal image and OCT scan analysis, interpretation, and reporting
  • Monitoring disease progression over time through comparative analysis of patient images

What Physicians Need to Know

Retinal Image Analysis (Fundus/OCT)
RetinaLyze analyzes both fundus images and OCT scans to detect signs of eye diseases. It can detect over 70 pathological signs in OCT scans within 45 seconds and provides results for fundus images within 30 seconds. The system analyzes the macula area of the retina from OCT scans.
Diabetic Retinopathy Screening Accuracy
RetinaLyze screens for signs of Diabetic Retinopathy (DR). In one study, it demonstrated a sensitivity of 84.9% and specificity of 89.9% for DR detection when compared to human grading at a clinical threshold. A large UK study reported a screening sensitivity of 91.3% and specificity of 91.1%. A PhD thesis exploring AI in DR screening showed an Area Under the Curve (AUC) of 93.4%. However, an earlier study noted a sensitivity of 35.7% and specificity of 83.3% for sight-threatening DR (STDR) screening, suggesting its validity was 'less than desired' in that specific context.
Glaucoma Detection
The system offers an advanced Glaucoma Progression AI, including a 'Glaucoma Index of Progression' (GIP), for early detection and tracking of glaucoma over time. It analyzes optic nerve head sectors, cup/disc ratio, hemoglobin pseudo-color maps, and vessel segmentation. A study involving over 1,800 cases reported a specificity of 95.5% and sensitivity of 86.5% for glaucoma detection. It can assess glaucoma risk using only fundus images, with performance comparable to visual perimetry and OCT screening.
Age-Related Macular Degeneration Screening
RetinaLyze screens for signs of Age-Related Macular Degeneration (AMD), specifically focusing on dry AMD indicators like drusen. It analyzes fundus images for minor white lesions that could indicate early signs of AMD.
Autonomous vs Assistive Diagnosis
RetinaLyze functions as a screening software and a clinical decision support system (CDSS), assisting eye care professionals. It detects pathological signs that require detailed examination by an ophthalmologist and can be used with a telemedicine module for manual assessment, indicating an assistive rather than autonomous diagnostic role.
Point-of-Care Deployment
Designed for use in various clinical and retail settings, including hospitals, eye clinics, optical chains, and optometrists' stores, RetinaLyze aims to make eye screenings more accessible. It provides instant results within 30-45 seconds, streamlining the screening process.
Screening Program Integration
RetinaLyze can be integrated into existing healthcare IT systems and supports automated image upload/export from over 60 different camera and OCT device partners. It centralizes patient data and retinal images, facilitating effortless comparison of changes over time and supporting digital referrals. It is utilized in national screening programs.
Sensitivity & Specificity Data
For Diabetic Retinopathy, RetinaLyze has shown a sensitivity of 84.9% and specificity of 89.9% in one study, and a screening sensitivity of 91.3% and specificity of 91.1% in another large UK study. For Glaucoma detection, it achieved a sensitivity of 86.5% and specificity of 95.5% in a study involving over 1,800 cases.
Physician Tip

RetinaLyze serves as a valuable assistive AI tool for early detection and monitoring of key retinal diseases (DR, AMD, Glaucoma) from fundus and OCT images. While it offers rapid, automated analysis and high sensitivity for screening, remember it functions as a clinical decision support system, not an autonomous diagnostic tool. Always integrate the AI results with your clinical expertise, patient history, and other diagnostic tests. Utilize the built-in telemedicine module for manual assessment by specialists when indicated, especially for 'Yellow' or 'Red' results. Pay attention to image quality guidelines to ensure reliable AI analysis and avoid false positives/negatives. Leverage its ability to compare images over time and across both eyes for comprehensive patient management.

RetinaLyze is designed for seamless integration into existing clinical workflows, supporting automated image upload and export from over 60 different fundus cameras and OCT devices. It can be accessed via a web browser or integrated into healthcare center software systems. The platform also offers built-in telemedicine capabilities, allowing communication with ophthalmologists and creation of digital referrals, and can integrate with PACS/EHR systems for streamlined referral processes.

Details

Category Ophthalmology AI, Telehealth & Virtual Care
Pricing Contact sales — Not publicly disclosed; contact sales for specific tiers and offerings.
DeploymentCloud-based (web-based application)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Unknown AI-estimated

RetinaLyze is available in Europe and Mexico, but is not currently approved for use in the United States by the FDA. It holds EU CE and UK MHRA certifications.
Integrations
EHR Not specified
Specialties Ophthalmology

What the Web Says

RetinaLyze is an AI-powered and telemedicine-enabled eye screening software designed to help eye care professionals detect signs of pathology like glaucoma, diabetic retinopathy, and macular degeneration. It aims to streamline workflows, provide rapid results (often within 45 seconds), and facilitate safer referrals to ophthalmologists. The system integrates with over 60 devices and software partners, and has performed over 7 million screenings.

Overall: Positive

Strengths

  • Fast and efficient screenings with results in as little as 45 seconds.
  • Reduces the risk of false positive referrals to ophthalmologists.
  • Automates the flow of retinal images and OCT scans, improving workflow.
  • Provides explainable AI results with overlays highlighting potential changes, aiding communication and understanding.
  • Increases efficiency in hospitals and clinics by offloading routine tasks to nurses.
  • Clinically validated and compliant with data protection and medical device regulations (e.g., EU CE, GDPR, ISO13485).

Limitations

  • One pilot study showed lower agreement with a single ophthalmologist for diabetic retinopathy detection compared to another AI system, depending on the screening strategy.
  • Some Reddit discussions about retinal scans in general highlight concerns about being charged for services without prior consent or insurance coverage, though these are not specific to RetinaLyze.
  • No specific reviews or opinions from G2 or Capterra for RetinaLyze were found, making it difficult to assess user sentiment from those platforms.
  • Larger optometric retailers may take up to 6 months for full integration and staff education.

Based on reviews from: RetinaLyze.com, PMC (PubMed Central), Optometry Times, Eyes On Eyecare, YouTube, Facebook, Reddit

Last updated: 2026-08-12

Ratings & Reviews

No reviews yet. Be the first to review this tool!

Rate RetinaLyze

Clinical Value
Ease of Use
Integration
Support & Docs
Value for Money

Press & Coverage

RetinaLyze Blog
RetinaLyze introduces 3D ONH morphology visualization
RetinaLyze has released a new feature enabling 3D visualization of the optic nerve head morphology from standard 2D retinal images, based on research published in BMJ Open Ophthalmology (2025). This innovation provides structural and perfusion-based insights previously only available through OCT.
2026-01
RetinaLyze Blog
RetinaLyze launches redesigned clinical PDF report u2013 clearer communication for colleagues and patients
RetinaLyze is introducing a new, streamlined PDF report, available from January 15, 2026, to improve how results are communicated to colleagues, referrers, and patients. The redesigned report offers a cleaner visual experience and consistent presentation of findings.
2026-01
RetinaLyze Blog
RetinaLyze and OCULUS spol. s r.o. announce strategic cooperation to expand AI-powered eye screening across the Czechia
RetinaLyze announced a strategic cooperation with OCULUS spol. s r.o. to expand AI-powered eye screening and tele-ophthalmology across Czechia. This partnership aims to make accessible, high-quality retinal screening available to more patients and providers.
2024-12
Optometry Times
RetinaLyze System A/S unveils AI to aid in the early detection of glaucoma
RetinaLyze System A/S has unveiled an advanced glaucoma progression AI, featuring the Glaucoma Index of Progression (GIP), to provide a stable and consistent method for tracking glaucoma over time. This AI tool can detect subtle changes in disease progression and status.
2024-10
Ophthalmology Times
RetinaLyze debuts new Advanced Glaucoma Progression AI for disease tracking
RetinaLyze System A/S is launching a new AI-based tool, the Advanced Glaucoma Progression AI with Glaucoma Index of Progression (GIP), for consistent glaucoma tracking. The company focuses on AI and telemedicine solutions for diabetic retinopathy, age-related macular degeneration, and glaucoma.
2024-10
Journal of Personalized Medicine
Performance of a Support Vector Machine Learning Tool for Diagnosing Diabetic Retinopathy in Clinical Practice
This study examined the real-world performance of RetinaLyze software in identifying diabetic retinopathy (DR) in patients with diabetes. The software showed a sensitivity of 84.9% and specificity of 89.9% when compared to human grading.
2023-07
RetinaLyze Blog
RetinaLyze AI shows an AUC of 93,4% in new Ph.D. thesis
A new Ph.D. thesis by Tobias Nissen from Steno Diabetes Center Nordjylland/Aalborg University Hospital explores the use of AI in screening for diabetic retinal changes, with RetinaLyze AI demonstrating an AUC of 93.4%. The research highlights the potential of AI as an assistive tool in diabetic retinopathy detection.
2023-10
RetinaLyze Blog
RetinaLyze System receives ISO 13485:2016 certification
RetinaLyze System announced that its quality management system has been independently audited and certified compliant with ISO 13485:2016. This certification demonstrates the company's commitment to providing medical devices and services that consistently meet regulatory requirements.
2022-06

Videos

Product demos, reviews, and walkthroughs for RetinaLyze.

View all on YouTube

Frequently Asked Questions

RetinaLyze is an AI-powered screening software that analyzes fundus images and OCT scans to detect signs of pathologies such as Diabetic Retinopathy (DR), Age-related Macular Degeneration (AMD), and Glaucoma. It functions as a clinical decision support system or a screening tool, providing instant, color-coded results within 30-45 seconds to aid in early detection and referral.
RetinaLyze System is ISO-13485 certified and all its services are CE-marked, demonstrating adherence to medical device quality management standards. It is also designed to comply with various data protection and medical device regulations, including EU GDPR, EU FADP, Brazil LGPD, Brazil ANVISA, UK MHRA, and the EU AI Act.
RetinaLyze is a screening tool and its results should not be considered a definitive diagnosis; manual assessment by an eye specialist is recommended for abnormal findings. Its accuracy can be affected by poor image quality, artifacts, or prior laser treatment, and some studies show variable sensitivity across different patient populations.
RetinaLyze operates on a subscription model where pricing varies based on the number of screenings performed monthly. Customers typically incur an average cost of less than u00a31 (or u20ac1.25) per fundus analysis and u00a31.5 (or u20ac2) per OCT analysis.
Several other AI-based retinal screening tools are available, including IDx-DR (LumineticsCore), which was the first FDA-approved autonomous AI diagnostic system, EyeArt by Eyenuk, and Retmarker. Google DeepMind/Google Health also offers advanced AI tools for retinal analysis.
RetinaLyze is designed for easy integration, compatible with over 60 different fundus and OCT cameras and their associated software. It streamlines the workflow by automating image analysis and can integrate with PACS/EHR systems for digital referrals, aiming to increase efficiency and offload routine tasks.
While RetinaLyze provides rapid AI-driven analysis, it functions as a screening and decision support tool, not a standalone diagnostic. For any results indicating changes or if the operator has doubts, the system includes a telemedicine module for manual assessment by an eye specialist to determine the necessary next steps.

Related Tools

RetiVue EntireEye Imaging
RetiVue, LLC
Ophthalmology AI
RetiVue manufactures ultrawidefield retinal cameras with automatic image capture, aiming to aid in the early documentation of eye disease and prevent blindness. Their EntireEye Imaging System offers both desktop and portable options, providing true color, high-detail images with a wide field of view for patients from infancy to adulthood.
Paid
AI Optics Sentinel Camera
AI Optics
Ophthalmology AI
AI Optics' Sentinel Camera is an FDA 510(k)-cleared handheld retinal imaging system designed to capture high-quality images for retinal disease screening, with future plans for integrated AI-based screening software for diabetic retinopathy, glaucoma, and macular degeneration.
RetCAD
Thirona
Ophthalmology AI
RetCAD is a CE-certified AI software product from Thirona that analyzes color fundus images for the presence of Age-related Macular Degeneration (AMD) and Diabetic Retinopathy (DR), aiding in early detection and grading of these vision-threatening conditions.
Paid; volume-based pricing options
Google Health (Ophthalmology AI)
Google Health
Ophthalmology AI
Google Health leverages AI and technology to improve healthcare globally, focusing on early disease detection, personalized wellness, and supporting healthcare professionals with advanced tools and research.
Subscription-based
Optivate AI Scribe
Optivate
Documentation & Scribing
Optivate's AI Scribe is designed specifically for ophthalmology, capturing clinical encounters in real-time to generate structured, accurate documentation and reduce charting time.
Cybersight AI
Orbis International
Clinical Decision Support & Reference
Cybersight AI is an AI-powered clinical decision support tool from Orbis International, designed to quickly and efficiently detect diabetic retinopathy, glaucoma, and other common eye diseases from fundus images. It is available for free in low- and middle-income countries, empowering nurses and technicians in underserved regions to conduct screenings and improve patient referral compliance.
Free

See all Ophthalmology AI tools →

Suggest an Edit → | Last Verified: 2026-05-13 | First Added: 2026-05-13
AI Tool Finder
AI-powered search. Results may not be comprehensive.