VIENNA, AUSTRIA – RetInSight GmbH, a Topcon Healthcare, Inc. company and a global leader in AI-based ophthalmic software, today announced that its Geographic Atrophy (GA) Monitor and Fluid Monitor solutions have received regulatory approvals from Australia’s Therapeutic Goods Administration (TGA) and Medsafe in New Zealand as Class IIa medical devices. These approvals mark a significant milestone in the company’s Asia-Pacific expansion and reaffirm its commitment to advancing clinical decision support for retinal diseases through scalable, device-agnostic AI solutions.

The approval of the GA Monitor in Australia comes at a pivotal time, as the first approved treatments for GA become available in the region. The combination of emerging therapeutic options and advanced AI-powered monitoring tools provides clinicians with new opportunities for early detection, personalized treatment strategies, and longitudinal disease tracking in both neovascular and non-neovascular forms of age-related macular degeneration (AMD).

“Our goal is to ensure that high-quality, AI-based tools for retinal disease management are globally accessible, scalable across healthcare systems, and interoperable with OCT devices beyond Topcon Healthcare’s own portfolio,” said Cornelia Kutzer, Managing Director and Chief Commercial Officer Solutions & cAIre of RetInSight. “We’re proud to receive these approvals and deliver timely support for clinicians in Australia and New Zealand as they begin to offer new treatments for GA.”

About RetInSight’s GA Monitor and Fluid Monitor

RetInSight’s GA Monitor and Fluid Monitor are AI-based software solutions developed to enhance the interpretation of OCT imaging in the management of AMD. Designed to support clinical judgement, not replace it, these tools provide reproducible, automated assessments that help physicians identify subtle disease activity before it becomes visually apparent.

• GA Monitor visualizes and quantifies the extent of photoreceptor and RPE loss, offering early-stage detection and disease progression insights for patients with dry AMD.
• Fluid Monitor delivers precise, quantitative analysis of intraretinal fluid (IRF), subretinal fluid (SRF), and pigment epithelium detachment (PED) for wet AMD, enabling more targeted therapy decisions.

Both solutions are integrated into a streamlined clinical workflow, generating a clear, one-page PDF report to support disease staging, monitoring, and effective patient communication.

As part of Topcon Healthcare’s global Healthcare from the Eye™ strategy, RetInSight is helping redefine how retinal diseases are detected, monitored, and managed, empowering clinicians worldwide with actionable insights derived from retinal imaging. Together, we are building a future where AI accelerates access to personalized care, regardless of geography or device.

About RetInSight

RetInSight GmbH, based in Vienna, is part of Topcon Healthcare, Inc., and shares its vision of transforming healthcare through the Healthcare from the Eye™ initiative, using retinal imaging and AI-driven tools to improve the management of systemic and ocular disease such as AMD with earlier detection and more personalized care.

RetInSight Founded in 2020 with the aim of enabling people to maintain their vision and preserve their quality of life and lifelong autonomy, RetInSight is developing transformative AI-based software solutions that leverage routine optical coherence tomography (OCT) images to monitor and detect progressive retinal diseases such as geographic atrophy (GA), neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO) –  diseases that result in significant visual impairments in today’s world. Our mission is to revolutionize ophthalmology through reliable, affordable, easy-to-use AI-based medical software for timely diagnosis, accurate monitoring, and personalized treatment of retinal diseases. For more info, visit www.retinsight.com

If you are a retina specialist, eye clinic, or imaging center interested in implementing RetInSight’s clinical decision support tools, please email us at [email protected].

About Topcon Healthcare, Inc.

Topcon Healthcare, Inc. is part of Topcon Corporation, a leading provider of digital healthcare solutions. Our vision is to improve access and quality of healthcare while decreasing the cost of care. To achieve this vision, we created Healthcare from the Eye™, a connected care ecosystem using AI-powered disease detection and management applied to noninvasive retinal imaging.

For more information, please visit topconhealthcare.com

Media Contact

RetInSight GmbH
Klaudia Schuh
Head of Marketing & Communications
E-Mail: [email protected]
MCA #5985