RetinAI and FVS Announce CE-MDR Certification for Co-developed AI-based Diabetic Retinopathy Screening Algorithm, LuxIA®

Bern, Switzerland and Madrid, Spain — 30 April 2025 — 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.