LuxIA receives CE-MDR certification

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RetinAI US Inc. and Fundación Ver Salud issued a joint press release¹ that LuxIA, the co-developed innovative AI algorithm for Diabetic Retinopathy (DR) screening, has 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.

The program, LuxIA, is designed to screen adult diabetic patients for more-than-mild diabetic retinopathy (mtmDR). The companies shared that this new certification shows their commitment to deliver AI-driven tools that meet stringent regulatory standards and significantly enhance patient management and clinical outcomes.

Dr. Carlos Ciller, CEO and co-founder of RetinAI, commented on this certification and the future of LuxIA in the joint press release,¹ saying, “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 also shared his thorugh on the certification, saying, “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.”¹

The device is indicated for processing digital 45-degree colour fundus images from NW200, NW400 or equivalent Topcon cameras. 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.¹

Reference:

1. RetinAI and FVS Announce CE-MDR Certification for Co-developed AI-based Diabetic Retinopathy Screening Algorithm, LuxIA®. RetinAI US Inc. April 30, 2025. Accessed April 30, 2025. https://www.morningstar.com/news/globe-newswire/1001093193/retinai-and-fvs-announce-ce-mdr-certification-for-co-developed-ai-based-diabetic-retinopathy-screening-algorithm-luxia