RetInSight

by Topcon Healthcare  · Based in United States →From Image to InSight Your partner in advancing ophthalmology with AI
Ophthalmology

Not publicly disclosed.
Regulatory Status Disclosed

Overview

RetInSight, a Topcon Healthcare company, is a leader in AI-based ophthalmic software, empowering eye care providers, academic institutions, and the eye care industry to reimagine clinical care with advanced artificial intelligence solutions. The company leverages data to deliver novel insights into unmet diagnostic needs associated with diseases that manifest in the retina.

As a spin-off of the Medical University of Vienna, RetInSight stands on a foundation of over a decade of global academic leadership in AI-based retinal image analysis. Their interdisciplinary team is dedicated to preserving eyesight throughout a lifetime by bringing AI to the eye. The company’s mission is to revolutionize ophthalmology through reliable, affordable, and easy-to-use AI-based medical software that enables timely diagnosis, accurate monitoring, and personalized treatment of retinal diseases.

RetInSight develops and delivers its solutions and services on a comprehensive and flexible AI platform, offering cloud-based AI modules tailored to various needs, including stand-alone use, device integration, and PACS integration.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-driven GA Monitor for Geographic Atrophy assessment and treatment evaluation
  • AI-powered Fluid Monitor for precise fluid quantification and treatment response analysis in nAMD, DME, RVO
  • Automated segmentation and quantification of retinal fluid types (IRF, SRF, PED) and GA lesions
  • Customized, one-page PDF reports for physicians and patients
  • Seamless integration into current OCT routine and PACS systems (Heidelberg Engineering Spectralis OCT with HEYEX 2.6 / AppWay; Topcon Triton OCT with Harmony)
  • Cloud-based AI modules with stand-alone, device integration, and PACS integration options
  • Dynamic follow-up charts for fluid dynamics and disease progression visualization
  • Support for clinical studies and pharmaceutical trials (cAIre - center for AI reading excellence)

Use Cases

  • Revolutionizing management of Geographic Atrophy (GA)
  • Monitoring and analyzing fluid levels in neovascular Age-Related Macular Degeneration (nAMD), Diabetic Macular Edema (DME), and Retinal Vein Occlusion (RVO)
  • Improving clinical efficiency and workflow for eye care professionals
  • Advancing scientific knowledge and drug development through collaborative clinical research and retrospective analysis
  • Supporting timely diagnosis, accurate monitoring, and personalized treatment of retinal diseases
  • Enhancing patient communication and compliance with easy-to-understand reports

Details

Category Ophthalmology AI
Pricing Not publicly disclosed.
DeploymentCloud-based AI modules; Stand-alone, device integration, and PACS integration (Heidelberg Engineering Spectralis OCT with HEYEX 2.6 / AppWay; Topcon Triton OCT with Harmony).
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

RetInSight was FDA approved in 2022 for precise analysis of OCT images and retinal disease monitoring. It has also received regulatory approvals as Class IIa medical devices from Australia’s Therapeutic Goods Administration (TGA) and Medsafe in New Zealand in August 2025, and holds MDR CE-certification in Europe.

Integrations
EHR Not specified
Specialties Ophthalmology

What the Web Says

RetInSight is an AI-powered software that analyzes Optical Coherence Tomography (OCT) images to detect and monitor retinal diseases like neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), retinal vein occlusion (RVO), and geographic atrophy (GA). It aims to improve efficiency in clinical routines, provide more precise measurements than human graders, and offer real-time insights for treatment decisions. The system has received EMA approval in Europe and FDA approval in the US for certain applications.

Overall: Positive

Strengths

  • Increases efficiency and reduces repetitive work for physicians.
  • Provides precise quantification of fluid levels and other biomarkers in nanoliters, which can be superior to human analysis.
  • Enables more accurate determination of treatment initiation and customizable treatment approaches.
  • Offers comprehensive reporting and real-time decision-making based on fluid volume changes.
  • Supports multiple OCT systems and is compatible with any web browser, allowing for user-friendly integration.
  • Aids in scientific research and pharmaceutical trials by providing advanced data analytics and supporting AI-powered drug development.

Limitations

  • Potential for over-referrals due to lower specificity and a high false positive rate in some AI screening tools for retinal conditions (general AI in ophthalmology concern, not specific to RetInSight).
  • Scarcity of head-to-head studies comparing different AI models in ophthalmology, making it difficult to understand expected performance in real-world scenarios and address potential biases.
  • General concern about retinal scans being charged without prior consent or clear explanation of separate costs in some practices (general patient experience, not specific to RetInSight).

Based on reviews from: RetInSight (retinsight.com), Eyes On Eyecare, Healio, Optometry Times, PubMed Central (PMC), Reddit, Capterra, Trustpilot

Last updated: 2026-07-24

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Press & Coverage

RetInSight
Topcon Healthcare Acquires RetInSight to Accelerate AI-Powered Imaging Innovation in Eye Care
Topcon Healthcare, a leading provider of medical devices, announced its acquisition of RetInSight GmbH, an Austrian company specializing in AI-based retinal imaging solutions, to advance AI-powered innovation in eye care. This acquisition aims to integrate RetInSight's AI algorithms with Topcon's clinical data management system, Harmony, to enhance clinical decision support and expand AI deployment globally.
2025-05
RetInSight
Regulatory Approvals for AI-Powered Retinal Disease Monitoring
RetInSight GmbH, a Topcon Healthcare company, received regulatory approvals from Australia's TGA and New Zealand's Medsafe for its Geographic Atrophy (GA) Monitor and Fluid Monitor solutions as Class IIa medical devices. These approvals mark a significant step in the company's expansion into the Asia-Pacific region, providing clinicians with advanced AI tools for early detection and personalized treatment strategies for retinal diseases.
2025-08
RetInSight
Innovative AI-Powered Imaging: Universitu00e4ts-Augenklinik Wu00fcrzburg Integrates RetInSight Software Into AMD Diagnostics
The Universitu00e4ts-Augenklinik Wu00fcrzburg (University Eye Hospital Wu00fcrzburg) became the first university clinic in Germany to integrate RetInSight's medical software into its AMD diagnostics. This integration aims to revolutionize diagnosis and therapy in medicine with AI technology, enabling precise diagnosis of age-related macular degeneration (AMD) and optimizing treatment timing.
2025-04
RetInSight
RetInSight Announces Exclusive Distribution Agreement with Kilabs Srl for the Italian Market
RetInSight GmbH has entered into an exclusive distribution agreement with Kilabs Srl for the Italian market. This partnership aims to expand the reach of RetInSight's AI-powered and MDR-certified medical software solutions for retinal diseases in Italy.
2025-02
RetInSight
RetInSight and veonet launch comprehensive collaboration to improve AMD care
RetInSight and veonet, a leading network of ophthalmology care centers, have partnered to integrate RetInSight's Fluid Monitor and GA Monitor software solutions into veonet's clinical routine. This collaboration aims to improve AMD care through AI-based image analysis, providing standardized evaluations and personalized treatment plans.
2024-07
RetInSight (Eye journal)
Artificial intelligence in assessing progression of age-related macular degeneration
This review article discusses the role of artificial intelligence (AI) in assessing the progression of age-related macular degeneration (AMD). It highlights how AI algorithms can provide fast and objective solutions for analyzing large amounts of data from imaging modalities, aiding in personalized patient care and evaluating individual responses to treatment.
2024-09
RetInSight
RetInSight secures the first MDR CE-certification for its AI-based GA Monitor for the management of geographic atrophy
RetInSight announced the launch of its GA Monitor, the first AI-based medical software solution for automated image analysis in geographic atrophy (GA) to receive MDR CE-certification as a Class II medical device. This innovation allows for precise visualization and quantification of photoreceptor and RPE degeneration, supporting timely diagnosis and personalized treatment.
2023-11
Eye Care Network - Ophthalmology Times
RetInSight and Heidelberg Engineering partner to implement AI-based geographic atrophy analysis for OCT imaging
RetInSight has partnered with Heidelberg Engineering to integrate its AI-based GA Monitor into Heidelberg AppWay, a secure platform for ophthalmic apps. This collaboration aims to deploy the first medical software solution using AI for automated analysis of geographic atrophy (GA) images, approved under EU MDR 2017/745 as a Class II medical device.
2023-11

Videos

Product demos, reviews, and walkthroughs for RetInSight.

View all on YouTube

Frequently Asked Questions

RetInSight seamlessly integrates into your existing OCT routine, providing automated analysis of OCT images. It is compatible with Heidelberg Engineering Spectralis OCT (via HEYEX 2.6 / AppWay) and Topcon Triton OCT (with Harmony). The system generates customized PDF reports for efficient workflow and supports clinical decision-making.
RetInSight holds MDR CE-certification (EU Medical Device Regulation 2017/745) and its Fluid Monitor received FDA approval in 2022. The company also adheres to high quality and regulatory compliance standards including GDPR, HIPAA, ISO 13485, and ISO 27001, ensuring data privacy and device reliability.
While other AI solutions like Altris AI, Infervision, and systems from Google and Microsoft exist for retinal image analysis, RetInSight differentiates itself by being pioneering MDR CE-certified AI solutions specifically for routine clinical use by eye care professionals. It focuses on precise, objective quantification of fluid and atrophy in AMD, including photoreceptor degeneration in GA, which is difficult to detect manually.
Specific pricing details for RetInSight are not publicly available in the search results. Interested physicians are typically encouraged to request a demo or contact the company directly for product information and a customized quote.
Like all AI tools, RetInSight's accuracy depends on the quality and representativeness of the training data. It is designed to support clinical judgment by providing precise, objective assessments and visualizations, not to replace the physician's expertise. Physicians should integrate the AI's insights with their comprehensive clinical evaluation for optimal patient management.
RetInSight's AI solutions are primarily designed to revolutionize the management of age-related macular degeneration (AMD), including intermediate AMD, geographic atrophy (GA), and neovascular (n)AMD. The GA Monitor and Fluid Monitor specifically address these conditions by providing accurate disease assessment and treatment evaluation.

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Suggest an Edit → | Last Verified: 2026-04-24 | First Added: 2026-04-24
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