Four of Ikerian’s products are now registered as Class IIa medical devices under the European Union Medical Device Regulation (Regulation (EU) 2017/745) (EU-MDR), strengthening its position in the AI healthcare technology space. The Certificate applies to its Ophthalmology Data Platform ‘RetinAI Discovery’ and three AI-based models to identify and quantify retinal layers, retinal fluids and retinal biomarkers.
Ikerian AG, the parent company of RetinAI U.S. Inc, develops software solutions for the ophthalmology and optometry market to collect, organize and analyse health data from the eyes. Its solutions, 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 are now 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 receipt of the EU MDR Certificate is a major milestone in the company’s journey for it is 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 as highlighted by 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” he said.
“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.”
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.
(Press release/RAN)
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