RetinAI Discovery from Ikerian receives Class IIa MDR registration in EU


The diagnostic and monitoring tools use artificial intelligence-based models.

Image credit: AdobeStock/Lucky Ai

(Image credit: AdobeStock/Lucky Ai)

In a press release, Ikerian AG, a medical software firm based jointly in Bern, Switzerland and in Boston, Massachusetts in the US, provided an update on four devices. The EU Medical Device Regulation (MDR) authority issued a Class IIa medical device certificate for RetinAI Discovery, Ikerian’s artificial intelligence (AI)-based platform.1 The Discovery tool’s modules use AI to identify and quantify biomarkers in the retina, aiding in fluid and layer segmentation. The diagnostic capabilities are intended to detect and monitor retinal disease.

In 2021, the data platform and AI modules received certification under the European Medical Device Directive (MDD) policy. Now, registration for the tools have been updated to reflect the MDR certification; the MDR requirements are more rigorous than that of the former MDD label.1

Earlier this year, Ikerian launched RetinAI Discovery for Clinics in the US, in two versions to address the needs of ophthalmologists and optometrists.2 The Discovery platform and its AI modules have received CE mark certification in the EU. According to the company, the multi-modality platform aggregates large datasets within a single repository before analysing data for physician reference in assessing retinal pathologies.

Carlos Ciller, PhD, CEO and co-founder of Ikerian and RetinAI, commented on the updated MDR certification. “The EU-MDR is among the world’s most robust regulatory frameworks for healthcare technology, with the highest standards on the clinical investigation and sale of medical devices for patients,” he said.1 “The significant number of AI-based certified products we have obtained in ophthalmology highlights our dedication to innovation in the space to maintain high-quality standards in the development of our products, together with our compliance of GDPR data privacy and security laws in the EU.”

CSO and co-founder Sandro De Zanet, PhD, reiterated the message in his own statement. “This significant milestone is a reflection of our team’s hard work and commitment to deliver safe and reliable medical devices for healthcare”, he stated.1 “The EU-MDR Certificate of RetinAI Discovery and its AI models will firmly place confidence in healthcare providers across the European Union that we are delivering the highest standard of care to support the management of their patients in Ophthalmology.”

  1. Ikerian (parent company of RetinAI U.S. Inc.) receives EU-MDR Certificate for four devices, its Ophthalmology Data Platform and AI models. Press release. Published 24 June, 2024. Accessed 24 June, 2024.
  2. Hutton, D. RetinAI debuts Discovery platform to boost ophthalmic care. Modern Retina. Published 21 February, 2024. Accessed 24 June, 2024.
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