RetinAI Discovery

by RetinAI  · Based in Switzerland → — Transformative AI & data management platform to enable the right decisions sooner in Healthcare.
Ophthalmology

Contact for pricing
Regulatory Status Disclosed

Overview

RetinAI Discovery is a CE-Marked and FDA-cleared medical image and data management platform with integrated AI modules. It is designed to aggregate data and extract automatic insights on patient diseases and outcomes in ophthalmology. The platform can be configured to connect to PACS or integrate via API calls with existing clinic systems, providing a secure, cloud-based solution with real-time data access. Its AI modules are used for analyzing OCT and fundus images to detect and monitor various retinal pathologies, including diabetic retinopathy, diabetic macular edema, glaucoma, and geographic atrophy. The platform also supports patient selection for clinical trials by identifying biomarkers and quantifying fluid and layers in retinal pathologies. For clinics and hospitals, it offers a unified medical and imaging data platform, while for life sciences and pharma, it accelerates R&D and real-world evidence generation.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • CE-Marked medical image and data management platform
  • Certified AI Models for automatic insights (fluid, layer segmentation, biomarkers)
  • Aggregates data across multiple imaging types (OCT, Fundus, DICOM, PDF, JPEG, PNG, TIFF)
  • Connects to PACS or integrates via API calls with clinic systems
  • Secure, cloud-based platform with real-time data access
  • AI-powered patient selection and stratification for clinical trials
  • Tele-Ophthalmology platform for remote collaboration and case sharing
  • Automated OCT data synchronization via Discovery CONNECT
  • Vendor-neutral platform compatible with major OCT devices (Heidelberg, Zeiss, Topcon)
  • Patient Passport feature for patients to access their clinical data

Use Cases

  • Data connectivity and aggregation for ophthalmology clinics and hospitals
  • Patient selection and stratification for clinical studies and trials using AI
  • Tele-Ophthalmology for remote collaboration, management, and peer referrals
  • Accelerating R&D and drug development for pharmaceutical and life sciences companies
  • Real-world evidence generation and analysis in ophthalmology
  • Monitoring and evaluating disease progression and treatment outcomes over time

What Physicians Need to Know

Retinal Image Analysis (Fundus/OCT)
RetinAI Discovery is a multi-modality platform that supports viewing and navigating all patient data, including OCTs, Fundus images, DICOM datasets, and other image formats. It utilizes AI models for precise retinal layer segmentation, accurate fluid volume assessment, and automated analysis of OCT volumes.
Diabetic Retinopathy Screening Accuracy
The platform includes LuxIAu00ae, a CE-marked AI medical device for screening more-than-mild diabetic retinopathy (mtmDR) from 45u00b0 color fundus images. LuxIAu00ae demonstrates 97% sensitivity and 95% specificity for mtmDR, with an Area Under the Curve (AUC) of 0.96, supporting timely referrals.
Glaucoma Detection
RetinAI Discovery can be used to monitor patients with glaucoma and neuro-ophthalmic diseases. The 'Discovery UNITY' product also mentions AI models for analysis in glaucoma.
Age-Related Macular Degeneration Screening
The tool supports monitoring of macular diseases, including Age-related Macular Degeneration (AMD), geographic atrophy (GA), and neovascular AMD. It features Research Use Only (RUO) AI models for detailed GA analysis, including segmentation from OCT scans and simulation of atrophy progression over 54 months.
Autonomous vs Assistive Diagnosis
RetinAI Discovery functions as an assistive tool, providing AI-powered insights to enhance clinical decision workflows, optimize outcomes, and aid physicians in their decisions and referrals, rather than offering autonomous diagnosis.
Point-of-Care Deployment
Designed for clinics and hospitals, the cloud-based platform facilitates real-time data access and is intended to deliver insights at the point of care. It is user-friendly, supporting easy image uploads. Discovery CONNECTu00ae automates real-time OCT data uploads from devices, streamlining workflows.
Screening Program Integration
The platform streamlines clinical decision workflows, tele-ophthalmology management, and referral decisions. It integrates with existing clinic systems via API calls or PACS and supports seamless integration with various OCT devices through Discovery CONNECTu00ae.
Sensitivity & Specificity Data
For Diabetic Retinopathy (LuxIAu00ae), it shows 97% sensitivity and 95% specificity for mtmDR. For fluid and layer segmentation in OCT, AI models achieved >95% agreement with human graders. Specific fluid detection metrics include: IRF (accuracy 0.87-0.93, specificity 0.88-0.95, sensitivity 0.84-0.93) and SRF (accuracy 0.93-0.95, specificity 0.93-0.95, sensitivity 0.93-0.95). For Geographic Atrophy (RORA), the model matches human expert performance with Dice scores of 0.881 and 0.844.
FDA De Novo vs 510(k) Pathway
RetinAI Discoveryu00ae platform has received U.S. Food and Drug Administration (FDA) 510(k) clearance. Its AI modules for biomarkers, fluid, and layer segmentation are designated as Research Use Only (RUO) in the USA. LuxIAu00ae is CE-marked, and the company had plans for its FDA submission.
Physician Tip

Leverage the unified platform to manage all patient data (OCTs, Fundus, etc.) from various devices, reducing the need for multiple viewers and enhancing data harmonization. Utilize the CE-marked LuxIAu00ae AI model for efficient and accurate screening of more-than-mild Diabetic Retinopathy, facilitating timely referrals. Employ the AI models for advanced analysis of macular diseases, including precise retinal layer segmentation, fluid volume assessment, and geographic atrophy progression prediction, to optimize treatment decisions and patient monitoring. Integrate Discovery CONNECTu00ae for automated, real-time upload of OCT data, streamlining workflows and providing immediate access to scans for faster diagnostics. Use the platform's tele-ophthalmology features for secure, real-time peer referrals and enhanced communication, especially in multi-center settings or for remote consultations. Capitalize on the progression analytics and visualization tools to educate patients on their disease progression and treatment outcomes, improving engagement.

RetinAI Discovery is a vendor-neutral, multi-modality platform compatible with various imaging devices (e.g., Heidelberg, Zeiss, and Topcon OCT devices). It can connect to PACS or integrate via API calls with existing clinic systems. Discovery CONNECTu00ae automates data uploads from OCT devices, supporting Windows, Linux, or macOS. The platform supports DICOM-compliant and other image formats and integrates electronic case report forms (eCRFs) for collecting clinical data.

Details

Category Ophthalmology AI
Pricing Contact for pricing
  • Discovery CORE: 179 € per month per user (after 2-month free trial); Disease Evaluation Apps: pricing based on usage level
DeploymentCloud-based
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

RetinAI Discovery® platform is a medical device cleared for clinical use by the FDA. The AI modules for biomarkers, fluid, and layer segmentation and quantification in retinal pathologies are designated as Research Use Only (RUO) in the USA.

Integrations
EHR Not specified
Specialties Ophthalmology

What the Web Says

RetinAI Discovery is a cloud-based, AI-powered platform designed to enhance ophthalmic research and clinical workflows by analyzing medical imaging data, such as OCT and fundus images. It aims to accelerate research analysis, support clinical decision-making, and improve patient management in retinal diseases like diabetic retinopathy and age-related macular degeneration. The platform is FDA 510(k)-cleared and complies with HIPAA and GDPR regulations, offering features for data management, AI-driven biomarker quantification, and collaborative research.

Overall: Positive

Strengths

  • Accelerates research analysis and clinical decision workflows through AI-powered insights.
  • Provides automated and immediate analysis of OCT and fundus images, quantifying biomarkers and fluid volumes.
  • Supports multi-site collaboration and real-world evidence generation for clinical trials and research.
  • Offers progression analytics and visualizations to track disease trends and enhance patient engagement.
  • Vendor-neutral and multi-modality, accepting various data formats (DICOM, JPEG, PNG, PDF).
  • Cloud-based, GDPR and HIPAA-compliant, ensuring secure data management and real-time visibility.

Limitations

  • Limited public reviews available on platforms like G2, Capterra, and Reddit, making it difficult to gauge widespread user sentiment.
  • G2 indicates that there are not enough reviews to provide comprehensive buying insight.
  • Specificity of the LuxIA algorithm (integrated into Discovery) for diabetic retinopathy screening showed variability across different datasets.
  • The accuracy of AI medical devices can be affected by image quality and imaging technology used.
  • Lack of consensus on evidence requirements for AI medical devices in ophthalmology.
  • Potential cost-prohibitive nature for some physicians to routinely access services for data annotation.

Based on reviews from: G2, Ophthalmology Times, The Ophthalmologist, Retinal Physician, Clinical Insights in Eyecare, ResearchGate, YouTube (RetinAI's channel), RetinAI (official website), Verve Ventures, TVST (Translational Vision Science & Technology), PubMed Central

Last updated: 2026-07-21

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Press & Coverage

RetinAI
RetinAI Discoveryu00ae platform and AI tools launched to improve decision workflows, referrals and patient management in Clinics for Ophthalmologists and Optometrists
Ikerian AG and RetinAI Inc. launched RetinAI Discoveryu00ae for Clinics, an AI-enhanced platform designed to streamline clinical workflows, improve patient engagement, and accelerate decision-making for ophthalmologists and optometrists. The platform offers two versions to cater to the specific needs of these eye care professionals.
2024-02
RetinAI
RetinAI receives FDA Clearance for Discovery, our medical image & data management platform for Ophthalmology
RetinAI announced that its Discoveryu00ae platform, an image and data management solution for ophthalmology, received U.S. Food and Drug Administration (FDA) 510(k) clearance. This platform aims to enhance interoperability across clinical and clinical study ecosystems, allowing for the organization and analysis of various ophthalmic medical images.
2022-05
Eye Care Network
RetinAI Discovery from Ikerian receives Class IIa MDR registration in EU
Ikerian AG, the parent company of RetinAI, announced that its RetinAI Discovery platform received Class IIa medical device certification under the EU Medical Device Regulation (MDR). This certification, which is more rigorous than the previous MDD, applies to the platform's AI-based modules for identifying and quantifying biomarkers in the retina to aid in diagnosing and monitoring retinal diseases.
2024-06
RetinAI
EssilorLuxottica acquires RetinAI, accelerating transformative AI and data-powered eye health solutions
EssilorLuxottica acquired Ikerian AG, operating under the RetinAI brand, to enhance its med-tech portfolio with AI and data management solutions in eye care. RetinAI's Discovery platform, which is FDA-cleared and CE-marked, uses AI models to support the diagnosis and monitoring of various eye diseases.
2025-10
Ophthalmology Times Europe
Ikerian announces commercial expansion of RetinAI Discovery in Europe
Ikerian AG, RetinAI's parent company, secured u20ac7.4 million in Series B funding led by Sanoptis, an ophthalmology services provider. This investment will support the distribution of the RetinAI Discovery platform across Sanoptis's European network, aiming to enhance clinical workflows and personalize treatment pathways with AI.
2024-10
Retinal Physician
NEW PRODUCT APPLICATIONS: RetinAI Discovery Core Platform Accelerates Research
RetinAI Medical AG developed the Discovery Core platform to enable clinicians to perform expert-level data analysis more quickly and efficiently, particularly for quantifying disease biomarkers and endpoints from OCT images. The platform's AI models have shown high agreement with human graders in evaluating various retinal diseases.
2023-04
IOVS | ARVO Journals
AI-Based Natural History Characterization of Intermediate AMD Using Multilayer OCT Biomarkers from an Automated OCT Analyzer (RetinAI Discovery Platform)
A study presented at ARVO 2026 aims to evaluate the natural history of intermediate age-related macular degeneration (AMD) using the multilayer analytic capabilities of the RetinAI Discovery platform. The platform processes OCT volumes to extract structural biomarkers, supporting data-driven endpoint selection and enrollment strategies for clinical trials.
2026-07
IOVS | ARVO Journals
Multimodal Longitudinal Imaging and AI-Driven 3D Quantification of Retinal Fluid in Macular Pathologies.
This study leverages multimodal imaging and AI-based volumetric analysis using RetinAI Discovery to provide detailed, longitudinal assessment of 3D subretinal fluid (SRF) dynamics in patients with macular pathologies. The AI-enabled workflow objectively tracks SRF volume dynamics, illustrating changes under therapy.
2026-06

Videos

Product demos, reviews, and walkthroughs for RetinAI Discovery.

View all on YouTube

Frequently Asked Questions

RetinAI Discovery is a cloud-based, multi-modality platform designed to aggregate and analyze large datasets, including OCT and fundus images, to provide automated insights into retinal pathologies. It aids physicians in accelerating clinical decision workflows, monitoring macular diseases like AMD and diabetic retinopathy, and facilitating teleophthalmology and clinical research by tracking disease progression and outcomes over time.
RetinAI Discovery is CE-marked as a Class IIa medical device under the EU Medical Device Regulation (MDR) and has received FDA clearance (510(k) process) for its platform in the US. The platform is also compliant with GDPR for data privacy in the EU and HIPAA regulations in the US, ensuring the security and protection of sensitive patient health information.
Limitations include the necessity for clear images, as small pathological characteristics may be missed with unclear scans, and a potential drop in accuracy when analyzing multiple diseases simultaneously. Furthermore, the quality and quantity of the AI's training datasets directly impact its accuracy and capability, and the specific AI modules for biomarker analysis are designated as Research Use Only (RUO) in the USA, meaning they are not intended to replace professional medical advice.
Yes, several other AI-powered platforms offer retinal analysis capabilities. Notable alternatives include VUNO Med-Fundus AI, Altris AI, EyeArt by Eyenuk, and solutions from Google DeepMind, which also focus on identifying biomarkers and aiding in the diagnosis and management of retinal diseases. These platforms vary in their specific imaging modalities and disease detection focuses.
While specific pricing for the core RetinAI Discovery platform is not publicly detailed, its Disease Evaluation Apps, available via platforms like Heidelberg AppWay, operate on a usage-based or subscription model. This allows clinics to access various AI apps for conditions like nAMD, dAMD, DR/DME, CME, and GA, with credits utilized only upon active application use.
In the European Union, RetinAI Discovery's AI modules for biomarkers, fluid, and layer segmentation and quantification are CE-marked medical devices approved for clinical use. However, in the USA, these specific AI modules are currently designated as 'Research Use Only' (RUO) and are not intended to be a substitute for medical advice, diagnosis, or treatment.

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Suggest an Edit → | Last Verified: 2026-04-22 | First Added: 2026-04-22

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