RetinAI and FVS Announce CE-MDR Certification for Co-Developed AI-Based DR Screening Algorithm, LuxIA

RetinAI US and Fundación Ver Salud (FVS) have jointly announced that LuxIA, their co-developed 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. 

The device is indicated for processing digital 45-degree color 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.

"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," Dr. Carlos Ciller, CEO and co-founder of RetinAI, said in a company news release. "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.”