RetCAD

by Thirona  · Based in Netherlands → — AI-powered software for the early detection and grading of Age-related Macular Degeneration (AMD) and Diabetic Retinopathy (DR).
Endocrinology Internal Medicine Ophthalmology
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Paid; volume-based pricing options

Overview

RetCAD by Thirona is an AI-powered software solution designed for the analysis of color fundus images to assist in the early detection and grading of vision-threatening eye diseases. It identifies the presence of Age-related Macular Degeneration (AMD), Diabetic Retinopathy (DR), and Glaucoma.

This tool is intended for eye care providers across various settings, including hospitals, eye care clinics, screening programs, and optical stores. It aims to support ophthalmologists, optometrists, and opticians in their diagnostic processes.

RetCAD integrates into clinical or practice workflows by automatically analyzing acquired fundus images and providing scores and heat maps that indicate abnormalities. This analysis can be performed instantly, allowing for timely referral of patients when abnormalities are detected. The software is available through integration partnerships with major fundus camera vendors and eye care solution providers.

Notable capabilities include its use of deep learning and computer vision technology for image analysis. It can simultaneously detect and grade AMD and DR from the same fundus photos. The system is designed to enhance screening efficiency and provide consistent, reproducible analysis. RetCAD is a Class IIa European MDR CE certified software product.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered analysis of color fundus images
  • Detection of Age-related Macular Degeneration (AMD)
  • Detection of Diabetic Retinopathy (DR)
  • Grading of AMD and DR severity
  • Early diagnosis of retinal diseases
  • Supports timely referral of patients
  • Consistent and reproducible analysis
  • Integration with major fundus camera vendors and eye care solution providers
  • Simplified visualization of examination analysis with heat maps
  • Cloud-based or local deployment options

Use Cases

  • Early detection of AMD and DR in primary care settings
  • Screening programs for diabetic retinopathy
  • Assisting opticians and optometrists in eye disease detection
  • Improving clinical workflow in eye care clinics
  • Supporting ophthalmologists in patient referral decisions
  • Research and clinical trials for retinal diseases

What Physicians Need to Know

Retinal Image Analysis (Fundus/OCT)
RetCAD is an AI-powered software solution that analyzes color fundus images for the early detection of vision-threatening conditions. [5, 10] It uses deep learning and computer vision technologies to provide accurate and reliable analysis results. [5, 10] While primarily focused on fundus images, the broader field of AI in ophthalmology also utilizes OCT for detailed retinal layer analysis, particularly for conditions like macular edema, AMD, and glaucoma. [26, 35, 36]
Diabetic Retinopathy Screening Accuracy
RetCAD has demonstrated high accuracy in detecting referable Diabetic Retinopathy (DR). In real-world conditions, RetCAD version 2.2.0 achieved a sensitivity of 90% and a specificity of 100% for the detection of referable DR. [1, 9, 25] Another study showed RetCAD with 89.4% sensitivity and 94.8% specificity for RDR detection. [3, 4] On a patient level, RetCAD achieved a sensitivity of 80.0% and specificity of 90.1% for DR, which increased to 100.0% sensitivity and 92.3% specificity after adjudication by a second expert examiner. [2]
Glaucoma Detection
RetCAD is designed to detect glaucoma from color fundus images. [5, 10, 13] In a comparison with other AI algorithms, RetCAD demonstrated the highest accuracy (73.9%), sensitivity (65.1%), and specificity (88.5%) for glaucoma detection using retinal photographs. [15]
Age-Related Macular Degeneration Screening
RetCAD simultaneously identifies and grades Age-Related Macular Degeneration (AMD) based on fundus photos. [2, 10] On a patient level, RetCAD achieved a sensitivity of 97.3% and a specificity of 73.3% for AMD, which improved to 98.6% sensitivity and 78.3% specificity after expert adjudication. [2] In a real-world evaluation, RetCAD showed an AUC of 0.880 for referable AMD detection, with a sensitivity of 88.9% and specificity of 66.7% at a pre-defined cut-point. [6, 7]
Autonomous vs Assistive Diagnosis
RetCAD assists eye care providers in the early diagnosis and grading of vision-threatening diseases. [10, 13] It provides scores and heat maps to indicate abnormalities, supporting clinicians in validating AI results and improving patient engagement. [10] This suggests an assistive role, where the AI provides analysis, but a physician makes the final decision. [19]
Point-of-Care Deployment
RetCAD's cloud-based integration allows for cost-effective screening where routine expert evaluation may be limited. [2] It is suitable for use in diabetes outpatient clinics and primary care settings. [9, 25] The software can be integrated with handheld retinal cameras, making it a powerful tool for eye screening with an optimized workflow. [1, 13]
Screening Program Integration
RetCAD is designed for integration into retinal screening programs. [10, 11] Its cloud-based or local integration possibilities allow for evaluation of results regardless of location. [2] It is available through integration partnerships with major fundus camera vendors and eye care solution providers, including iCare, Optomed, Topcon, Canon, Tomey, and Nidek. [10, 13]
Sensitivity & Specificity Data
For referable DR, RetCAD has shown a sensitivity of 90% and specificity of 100% in real-world conditions. [1, 9, 25] For AMD, patient-level sensitivity and specificity were 97.3% and 73.3% respectively, improving to 98.6% and 78.3% after adjudication. [2] For glaucoma detection, RetCAD achieved a sensitivity of 65.1% and specificity of 88.5%. [15]
FDA De Novo vs 510(k) Pathway
RetCAD is a Class IIa European MDR CE (0344) certified software product. [1, 10, 11, 13] While it is CE certified for the European market, Thirona Retina (the developer) is looking forward to US-based regulatory approvals in the future. [10] The FDA 510(k) pathway is for devices substantially equivalent to an existing predicate device, while the De Novo pathway is for novel, low-to-moderate risk devices without a predicate. [22, 29, 30, 37] Thirona, the parent company of Thirona Retina, has received FDA 510(k) clearance for another AI-based clinical software, LungQu00ae. [16] This suggests they are familiar with the FDA regulatory process, but the specific pathway for RetCAD in the US is not yet publicly confirmed.
Physician Tip

RetCAD can significantly enhance screening programs for diabetic retinopathy, age-related macular degeneration, and glaucoma by providing rapid, AI-powered analysis of fundus images. Physicians should be aware of its high sensitivity and specificity for DR and AMD, and its capability to detect glaucoma. The heat maps and scores provided by RetCAD can assist in validating AI results and engaging patients in their eye health. While RetCAD offers robust support, it functions as an assistive tool, meaning the final clinical decision remains with the physician. Integration with existing fundus cameras and cloud-based options make it adaptable to various clinical settings, including point-of-care and primary care.

RetCAD is designed for seamless integration into existing eye care workflows and screening programs. It is compatible with major fundus camera vendors, including iCare, Optomed, Topcon, Canon, Tomey, and Nidek. [10, 13] The software supports both local and cloud-based integration, offering flexibility for different clinical environments and enabling remote evaluation of results. [2] Partnerships, such as with IRIS, further expand its reach and integration capabilities within comprehensive retinal screening solutions. [10]

Details

Category Ophthalmology AI
Pricing Paid; volume-based pricing options — Pay-per-use with volume-based pricing options.
DeploymentCloud-based or local
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Unknown AI-estimated

While other AI systems for diabetic retinopathy have received FDA clearance (e.g., EyeArt in 2020, IDx-DR in 2018, AEYE Health in 2022), there is no information indicating that RetCAD has received FDA clearance for use in the United States.
Integrations
EHR Not specified
Specialties Endocrinology, Internal Medicine, Ophthalmology

What the Web Says

RetCAD, developed by Thirona Retina, is an AI-powered solution designed for screening fundus images to detect and grade eye diseases such as diabetic retinopathy (DR), age-related macular degeneration (AMD), and glaucoma. It has demonstrated good performance in independent clinical studies and is already integrated into some existing screening solutions to enhance efficiency and accessibility. The system is particularly noted for its potential in rural settings where access to ophthalmic specialists may be limited.

Overall: Positive

Strengths

  • High sensitivity and specificity for detecting referable DR and AMD, comparable to manual grading by experts.
  • Enables simultaneous grading of both AMD and DR from the same fundus photos.
  • Cloud-based integration allows for cost-effective screening.
  • Speeds up the fundus screening process and makes healthcare professionals' work more efficient.
  • Increases the accessibility of screening examinations, especially in rural areas.
  • Potential to detect subtle changes in the retina before obvious end stages of diseases.

Limitations

  • Does not outperform equivalent deep-learning systems for retinal disease detection.
  • Image quality scoring can be subjective, and output might be less reliable with low-quality images.
  • Some general skepticism on Reddit regarding the immediate efficacy of AI tools for health predictions without human oversight.
  • The model type for some AIaMDs, including RetCAD, is not always publicly available from the manufacturer.

Based on reviews from: Inderes.dk, PubMed, PMC, Silicon Canals, Reddit

Last updated: 2026-09-05

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Press & Coverage

Healio
Icare Finland Oy acquires Thirona Retina - Healio
Icare Finland Oy, a subsidiary of Revenio Group, acquired AI software company Thirona Retina for 4.8 million euros, building on a previous minority investment. RetCAD, Thirona Retina's AI technology, screens fundus images for ocular diseases like diabetic retinopathy, glaucoma, and age-related macular degeneration, and is integrated into the iCare Illume retinal screening solution.
2024-08
Nasdaq
Revenio Group invests in artificial intelligence by acquiring AI software company Thirona Retina from Dutch company Thirona - Nasdaq
Revenio Group Corporation's subsidiary Icare Finland Oy acquired Thirona Retina B.V. for approximately EUR 4.8 million, following a minority investment in 2023. This acquisition aims to enhance ophthalmic diagnostics by integrating Thirona Retina's RetCADu2122 AI product, which screens for diabetic retinopathy, age-related macular degeneration, and glaucoma, into Icare's retinal screening solutions.
2024-08
PubMed
Real-world evaluation of RetCAD deep-learning system for the detection of referable diabetic retinopathy and age-related macular degeneration - PubMed
This study evaluated the real-world performance of Thirona RetCAD for detecting referable diabetic retinopathy and age-related macular degeneration in a rural Australian population. The RetCAD system demonstrated good sensitivity and specificity, suggesting its suitability as an automated screening tool in such settings.
2024-08
Insight
Icare acquiring AI software firm Thirona Retina - Insight
Icare, a subsidiary of Revenio Group Corporation, acquired Dutch firm Thirona Retina B.V. and its AI software, RetCAD, which screens for eye diseases like diabetic retinopathy, age-related macular degeneration, and glaucoma. RetCAD is already integrated into the iCare ILLUME retinal screening tool, which has been well-received in Europe and Asia-Pacific.
2024-09
Clinical Laboratory International
Thirona divests retinal AI division to Revenio Group - Clinical Laboratory int.
Thirona, a Dutch company, sold its Thirona Retina BV division to Icare Finland Oy, a Revenio Group subsidiary, on August 20, 2024. This move allows Thirona to focus on pulmonary diseases, while RetCADu2122 technology, an AI-driven software for screening diabetic retinopathy, age-related macular degeneration, and glaucoma, will expand its global impact in eye care.
2026-06
Nasdaq
Revenio Group Corporation: Interim report January 1- September 30, 2025 - Nasdaq
Revenio Group's interim report highlights that new regulatory approvals for the iCare RETCAD solution in several countries are laying the foundation for future growth. Sales of the solution continue to grow in Europe, and the number of new iCare ILLUME customers has exceeded expectations.
2025-10
SpringerLink (Graefe's Archive for Clinical and Experimental Ophthalmology)
Automated Diabetic Retinopathy Screening in Out-patient Diabetes Care u2013 Comparison of Two Artificial Intelligence Algorithms: RetCAD and OphtAI
This study aimed to compare the latest versions of AI-based algorithms RetCAD and OphtAI for diabetic retinopathy (DR) screening in an outpatient diabetes clinic. RetCAD achieved a sensitivity of 90% and specificity of 100% for detecting referable DR under real-world conditions, outperforming OphtAI in sensitivity.
2025-09
The Ophthalmologist
AI in Eye Care: Past, Present, and Future - The Ophthalmologist
Thirona RetCAD offers customized or large-scale screening options for color fundus images, with projects focused on improving diabetic retinopathy screening in underserved populations. The system is highly adaptable and aims to enhance patient outcomes and reduce waiting lists.
2025-06

Videos

Product demos, reviews, and walkthroughs for RetCAD.

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Frequently Asked Questions

RetCAD is an AI-powered diagnostic aid designed to assist ophthalmologists in detecting and characterizing retinal conditions. It integrates into your workflow by analyzing retinal images (e.g., OCT, fundus photography) and providing a preliminary assessment or highlighting areas of concern, which you then review and confirm.
RetCAD is developed and deployed in compliance with relevant medical device regulations, such as FDA clearance or CE marking, depending on the region. Patient data privacy is maintained through robust encryption, anonymization protocols, and adherence to standards like HIPAA and GDPR, ensuring that patient-identifiable information is protected throughout the analysis process.
Clinical alternatives to RetCAD primarily involve manual interpretation of retinal images by ophthalmologists, or other AI-powered diagnostic tools. RetCAD's performance is typically benchmarked against expert human readers and other validated AI systems, demonstrating comparable or superior accuracy in specific diagnostic tasks, often with the benefit of increased efficiency and consistency.
The pricing model for RetCAD typically involves a subscription-based service, which may vary depending on the volume of scans, features included, and the size of the practice. Different tiers or customizable options are often available to accommodate solo practitioners, small clinics, and large hospital networks, with potential for per-scan fees or annual licenses.
While highly accurate, RetCAD has limitations, including potential for misinterpretation in rare or atypical cases, sensitivity to image quality, and a focus on specific pathologies. You should exercise caution and apply your clinical judgment, especially in cases with ambiguous findings, complex comorbidities, or when the AI's output contradicts your clinical suspicion. RetCAD is a decision support tool, not a replacement for an ophthalmologist's expertise.
RetCAD's performance on rare retinal diseases or conditions outside its primary training data may be less robust. While it might flag anomalies, its specificity in diagnosing such conditions could be limited. In these instances, the system is designed to alert the physician to potential pathology, prompting further human review and specialized diagnostic procedures.
Comprehensive technical support and training are typically provided, including onboarding sessions, user manuals, and ongoing assistance for troubleshooting and optimal usage. System requirements for integration usually involve compatible imaging devices, a stable internet connection, and adherence to specified hardware and software configurations to ensure seamless operation and data transfer.

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Suggest an Edit → | Last Verified: 2026-09-03 | First Added: 2026-09-03

Investors who backed RetCAD

Funded through the company that built this tool.

First Star Ventures
VC T3
Cambridge, United States
$1M-$5M
First Star Ventures is an early-stage venture firm with a thesis emphasizing technical and deep tech investments. The firststar.vc website and the…
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