RetinAI and FVS Receive CE-MDR Certification for LuxIA Diabetic Retinopathy Screening

BERN, Switzerland, and MADRID, Spain — RetinAI US Inc. and Fundación Ver Salud (FVS) have received CE-MDR certification for LuxIA. The companies co-developed the innovative AI algorithm for Diabetic Retinopathy (DR) screening. The technology is classified as a Class IIb medical device under the EU Medical Device Regulation (EU MDR 2017/745). Ikerian AG, RetinAI’s parent company, granted the certification.

What is LuxIA?

LuxIA screens adult diabetic patients for more-than-mild diabetic retinopathy (mtmDR). This indication helps ophthalmologists and health care professionals in the EU diagnose mtmDR earlier, protecting vision. This certification showcases FVS and RetinAI’s collaboration and commitment to AI tools that meet regulatory standards and enhance patient care.

How to Use it

The device processes digital 45-degree color fundus images from NW200, NW400 or equivalent Topcon cameras. This ensures seamless placement into existing clinical workflows. LuxIA complements RetinAI’s AI-based OCT solutions, enhancing a suite of clinically validated, CE-certified AI modules for 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,” said Dr. Carlos Ciller, CEO and co-founder of RetinAI. “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.”

“We are excited about the newly received certification and look forward to the significant impact LuxIA will have in the European ophthalmology market,” said Dr. Juan Donate, MD, President of Fundación Ver Salud. “AI-driven screening solutions are critical to improving patient care, and we anticipate LuxIA will play a central role in achieving this.”

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