RetInSight secures the first MDR CE-certification for its AI-based GA Monitor for the management of geographic atrophy
Vienna, 2023, Nov. 9th – RetInSight, an Austrian company, leading in the field of artificial intelligence (AI)-based image analysis of retinal diseases, announces the launch of the RetInSight GA Monitor. The RetInSight GA Monitor is the first AI-based medical software solution for automated image analysis for routine clinical use in patients with geographic atrophy (GA), which is approved as a Class II medical device according to the EU Medical Device Regulation 2017/745 (MDR). For the first time, not only the end-stage lesions with complete loss of retinal pigment epithelium (RPE), but also the primary and disease-triggering degeneration of the photoreceptors (PR) can be visualized and quantified quickly, precisely, and objectively.
The RetInSight GA Monitor supports comprehensive management of GA based on optical coherence tomography (OCT), a high-resolution imaging technique widely used in clinical practice. The unique feature of the RetInSight GA Monitor is its capability for visualizing and measuring the condition of photoreceptors, which are fundamental to human vision. In GA, the progressive and irreversible deterioration of vision is initiated by photoreceptor thinning and loss, which is very difficult for ophthalmologists to detect on OCT images. With the help of specially trained AI-supported algorithms, the degree and extent of the thinning of the photoreceptors as well as the loss of the retinal pigment epithelium are identified by the software. The RetInSight GA Monitor therefore helps physicians identify patients in need of treatment on their first visit and track their disease progression by accurately measuring PR degeneration and RPE loss.
“With the launch of our GA Monitor, we are supporting ophthalmologists in clinical decisions by offering reliable software based on medical findings,” says Corinna zur Bonsen-Thomas, CEO of RetInSight GmbH. “The unique AI-based visualization of the photoreceptor layer sets us apart from other solutions and has the potential to fundamentally change the way ophthalmologists diagnose and treat GA patients. We are proud to be able to help preserve the vision and quality of life of millions of patients.”
In light of the two new therapies for the treatment of GA that have already been approved in the USA, and the therapeutic options that are subsequently expected in Europe, effective clinical management is becoming essential due to the increasing patient numbers. Fast, accurate and resource-efficient evaluation of OCT images through automated AI algorithms supports ophthalmologists in timely diagnosis, accurate monitoring of the disease stage, and personalized treatment.
About the RetInSight GA Monitor
The RetInSight GA Monitor is an AI-based OCT analysis medical software for objective detection, localization, and quantification of PR degeneration and RPE loss. The results are clearly summarized in a one-page PDF report, which is made available to the ophthalmologist within minutes at the click of a mouse. The graphic representation of the respective areas of PR and RPE integrity loss, their precise quantification, and the RPE/PR overlap as an indicator of the disease activity enable the ophthalmologist to comprehensively manage GA patients. The report’s easy-to-understand images also support patient communication.
About Geographic Atrophy
Geographic atrophy (GA) is the late stage, non-exudative form of age-related macular degeneration (AMD) and one of the most common causes of visual impairment and blindness. In GA, there is progressive degeneration of the light-sensitive cells in the macula, leading to irreversible loss of central vision. The disease often progresses unnoticed before the effects become noticeable.
Around five million people are affected worldwide, and the prevalence increases with age: 6% of people aged 50-59 have AMD and almost one in three between 80 and 85 years of age. 35% of blindness caused by AMD is due to GA.
RetInSight GmbH, based in Vienna, was founded in 2020 with the ambition that longevity should not come at the expense of vision loss. We aim to enable people to maintain their full vision in order to preserve their quality of life and lifelong autonomy. We are therefore developing transformative AI-based software solutions that leverage routine optical coherence tomography (OCT) images to monitor and detect progressive retinal diseases such as GA, neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO) – the most important age-related diseases that lead to visual impairments in today’s world. Our 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 for anyone, any time and at any location by supporting networked care in ophthalmology with the help of AI technology and digital data.
Klaudia Schuh, Marketing & Communications Manager
Tel: +43 (0)677 610 749 47
- Clinical validation for automated geographic atrophy monitoring on OCT under complement inhibitory treatment. Mai J, Lachinov D, Riedl S, Reiter GS, Vogl WD, Bogunovic H, Schmidt-Erfurth U. Sci Rep. 2023Apr 29;13(1):7028.
- The Eﬀect of Pegcetacoplan Treatment on Photoreceptor Maintenance in Geographic Atrophy Monitored by Artiﬁcial Intelligence-Based OCT Analysis. Riedl S, Vogl WD, Mai J, Reiter GS, Lachinov D, Grechenig C, McKeown A, Scheibler L, Bogunović H, Schmidt-Erfurth U. Ophthalmol Retina. 2022 Nov;6(11):1009-1018. doi: 10.1016/j.oret.2022.05.030