Ikerian (parent company of RetinAI U.S. Inc.) receives EU-MDR Certificate for four devices, its Ophthalmology Data Platform and AI models

Bern & Boston, US, June 24^th, 2024 - Ikerian AG (“Ikerian”) a leader in developing software solutions for medical image and data management and artificial intelligence (AI) in healthcare, today announced the registration as Class IIa medical devices under the European Union Medical Device Regulation (Regulation (EU) 2017/745) (EU-MDR) of 4 devices. The Certificate applies to RetinAI Discovery^®, a transformative healthcare platform to unlock the power of digital data in Ophthalmology, and the AI-based models to identify and quantify retinal layers, retinal fluids and retinal biomarkers to aid in the diagnosis and monitoring of diseases in Ophthalmology.

“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,” said Dr. Carlos Ciller, CEO and co-founder of Ikerian and RetinAI. “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. We are committed to providing top-notch healthcare data and AI solutions to patients and healthcare providers.”

The MDR replaces the former European Medical Device Directive (93/42/EEC), including more rigorous requirements for clinical evaluation and post-marketing surveillance. It is an internationally recognized regulatory framework to ensure improved device safety and requires device companies to provide clinical data supported by clinical evaluation, risk management and quality management systems. The long-standing MDD Certificates the company obtained for its data platform and AI models - since 2021 - have now been transitioned to MDR. 

“This significant milestone is a reflection of our team’s hard work and commitment to deliver safe and reliable medical devices for healthcare”, says Dr. Sandro De Zanet, CSO and co-founder of Ikerian and RetinAI. “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.”

To learn more or to request a demonstration of RetinAI Discovery and its models for patient management, please visit retinai.com/products/discovery