RetinAI and FVS Announce CE-MDR Certification for Co-developed AI-based Diabetic Retinopathy Screening Algorithm, LuxIA®
BERN, Switzerland and MADRID, April 30, 2025 (GLOBE NEWSWIRE) -- RetinAI US Inc. (RetinAI) and Fundación Ver Salud (FVS) are pleased to jointly announce that LuxIA®, their co-developed innovative AI algorithm for Diabetic Retinopathy (DR) screening, has successfully received CE-MDR certification as a Class IIb medical device under the European Union Medical Device Regulation (EU MDR 2017/745). The certification was granted through Ikerian AG, RetinAI's parent company.
LuxIA is designed to screen adult diabetic patients for more-than-mild diabetic retinopathy (mtmDR). This indication for use provides critical support for ophthalmologists, general practitioners and trained healthcare professionals across the European Union to achieve an earlier diagnosis of mtmDR, a vision-threatening eye disease. This new certification demonstrates the strong collaboration between FVS and RetinAI, emphasizing both entities' commitment to deliver AI-driven tools that meet stringent regulatory standards and significantly enhance patient management and clinical outcomes.
The device is indicated for processing digital 45-degree colour fundus images from NW200, NW400 or equivalent Topcon cameras, ensuring seamless placement into existing clinical workflows. Together with RetinAI's existing portfolio of AI-based OCT analysis solutions, LuxIA complements a comprehensive suite of clinically validated, CE-certified AI modules focused on ophthalmology.
Dr. Carlos Ciller, CEO and co-founder of RetinAI, commented: 'Receiving CE-MDR certification for LuxIA underscores our shared commitment with FVS to advance leading-edge ophthalmic care to patients through reliable and impactful AI technology. This milestone is pivotal, enabling healthcare providers to improve patient management and outcomes for diabetic retinopathy across Europe, reinforcing our joint mission of transforming vision care through innovation.'
Dr. Juan Donate, MD, President of Fundación Ver Salud stated: 'We are excited about the newly received certification and look forward to the significant impact LuxIA will have in the European ophthalmology market. AI-driven screening solutions are critical to improving patient care, and we anticipate LuxIA will play a central role in achieving this.'
For further information or to request a demonstration of LuxIA and other ophthalmic solutions from FVS and RetinAI, please visit retinai.com.
For further information please contact:
At the company
Carlos Ciller, PhD, CEO - Ikerian AG and RetinAI Inc US [email protected], [email protected]
Media enquiries
Sue Charles, Charles Consultants - [email protected] +44 (0)7968726585
About Ikerian AG www.ikerian.com and RetinAI Inc. US www.retinai.com
Established in 2017, Ikerian AG (formerly RetinAI Medical AG) and its subsidiary, RetinAI U.S. Inc. ('Ikerian', 'RetinAI' and, together, 'the company'), develops software solutions to accelerate clinical, research and pharmaceutical workflows globally using advanced machine learning and computer vision, across ophthalmology, neurodegenerative disorders, vascular conditions, and rare diseases.
RetinAI builds tools to collect, organize and analyze health data from the eyes, enabling healthcare professionals to make the right decisions sooner in healthcare. RetinAI's international team leverages its clinical, technical, and scientific expertise to foster the transition from reactive to preventive medicine for severe eye diseases.
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About FVS www.fundacionversalud.es/
FVS is a non-profit organization focused on training, research, and medical innovation, particularly in the field of ophthalmology. Its mission is to develop solutions that promote better clinical outcomes and enhance the quality of patient care.
Follow us on LinkedIn https://www.linkedin.com/in/fundaci%C3%B3n-ver-salud-983a621b3/ and X https://x.com/fversalud
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Business Upturn
28 minutes ago
- Business Upturn
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None of the information on the Alvotech website shall be deemed part of this press release. About Advanz Pharma Partner of choice in specialty, hospital, and rare disease medicines. Advanz Pharma is a global pharmaceutical company with the purpose to improve patients' lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our headquarters are in London, UK. We have commercial sales in more than 90 countries globally and have a direct commercial presence in more than 20 countries, including key countries in Europe, the US, Canada, and Australia, a Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialization partner network. Advanz Pharma's product portfolio and pipeline comprises innovative medicines, biosimilars & specialty generics, and originator brands. 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Forward-looking statements generally relate to future events or the future financial or operating performance of Alvotech and may include, for example, Alvotech's expectations regarding future growth, results of operations, performance, future capital and other expenditures, competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, results, level of activities, performance, goals or achievements or other future events, regulatory review and interactions, the satisfactory responses to the FDA's inspection findings and resolution of other deficiencies conveyed following the re-inspection of Alvotech's manufacturing site, the potential approval, including for AVT02, AVT04, and the product candidates in scope of the partnership with Advanz, by the FDA and other regulatory agencies and commercial launch of its product candidates, the timing of the announcement of clinical study results, the commencement of patient studies, regulatory applications, approvals and market launches, and the estimated size of the total addressable market of Alvotech's pipeline products. In some cases, you can identify forward-looking statements by terminology such as 'may', 'should', 'expect', 'intend', 'will', 'estimate', 'anticipate', 'believe', 'predict', 'potential' or 'continue', or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech's control. 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Although Advanz Pharma believes that these assumptions were reasonable when made, by their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial consequences of the plans and events described herein. Actual results may differ from those set forth in the forward-looking statements as a result of various factors (including, but not limited to, future global economic conditions, changed market conditions affecting the industry, intense competition in the markets in which Advanz Pharma operates, costs of compliance with applicable laws, regulations and standards, diverse political, legal, economic and other conditions affecting Advanz Pharma's markets, and other factors beyond the control of Advanz Pharma. 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