Bern & Boston, US, 24 June 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\
About RetinAI U.S. Inc. and Ikerian AG
Established in 2017, RetinAI (Part of Ikerian AG), develops software solutions to accelerate clinical, research and pharmaceutical workflows globally using advanced machine learning and computer vision.
Focused on the ophthalmology and optometry market, RetinAI builds tools to collect, organize and analyze health data from the eyes, enabling healthcare professionals to make the right decisions sooner in healthcare. RetinAI's international team leverages its clinical, technical, and scientific expertise to foster the transition from reactive to preventive medicine for severe eye diseases.
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About RetinAI Discovery®
RetinAI Discovery® and the AI modules for biomarkers, fluid and layer segmentation, and quantification in retinal pathologies are CE-Marked medical devices according to the Medical Devices Regulation (EU ) 2017/745. Discovery is a medical device cleared for clinical use by the FDA. The AI modules for biomarkers, fluid and layer segmentation and quantification in retinal pathologies are for research use only in the USA. Please be advised these tools are not intended to be a substitute for medical advice, diagnosis or treatment. We do not warrant any reliance on the accuracy, completeness or usefulness of any content. Please read the Privacy Notice and Data Processing Agreement for more information.
RetinAI Discovery and RetinAI are both trademarks of Ikerian AG.
