RetinAI U.S. and Fundación Ver Salud (FVS) have announced the CE-MDR certification of their jointly developed artificial intelligence (AI) algorithm, LuxIA, which is intended for the screening of more-than-mild diabetic retinopathy (mtmDR).
The certification, issued under the European Union Medical Device Regulation (EU MDR 2017/745), categorises LuxIA as a Class IIb medical device. The approval was granted via Ikerian, the parent company of RetinAI.
RetinAI CEO and co-founder Carlos Ciller said: “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.”
The LuxIA screening system has been developed to assist healthcare providers in detecting diabetic retinopathy at an earlier stage, thereby supporting clinical decision-making and enabling earlier intervention.
LuxIA processes 45° colour fundus images captured by Topcon NW200, NW400, or equivalent devices, ensuring compatibility with current diagnostic workflows used across ophthalmology clinics in the European Union.
RetinAI and FVS confirmed that the tool will be available to general practitioners, ophthalmologists, and other trained healthcare professionals for the specific task of screening adult diabetic patients for mtmDR.
The AI-based tool is designed to complement traditional care pathways and supports the early identification of patients at risk of vision loss due to diabetic complications.
RetinAI, through its parent company Ikerian (formerly RetinAI Medical), develops machine learning-based software tools for healthcare applications, with a focus on ophthalmology, neurodegenerative disorders, and rare diseases. The company builds technology platforms that collect, organise, and analyse ocular health data to assist clinical and research professionals in accelerating diagnosis and care planning.
Founded in 2017 and operating globally, Ikerian provides AI-enabled digital health tools aimed at transitioning clinical practice from reactive treatment models to proactive, preventive care. RetinAI’s offerings include a range of CE-certified AI modules that analyse optical coherence tomography (OCT) scans, now expanded with the addition of LuxIA.
FVS, a non-profit entity, contributes to medical innovation through its emphasis on education, training, and research in ophthalmology. Its mission is aligned with developing accessible, effective tools that improve diagnostic capabilities and patient outcomes.
FVS president Juan Donate said: “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.”
