Mediwale's DrNoon Approved as 'Cardiovascular Risk Prediction Medical Device' Under European CE MDR

Beyond Diagnosis: Realizing AI-driven Prevention

Mediwale, a medical artificial intelligence (AI) company, announced on May 6 that its retinal AI solution 'DrNoon' has obtained the CE MDR (Medical Device Regulation) certification for medical devices in Europe.

The CE MDR is the European Union's regulation for medical devices that must be satisfied to sell or supply medical devices in the European market. It replaced the previous Medical Device Directive (MDD) and has been in effect since 2021. The regulation significantly strengthens requirements for product safety, clinical evidence, quality management systems, and post-market surveillance.

DrNoon is an AI medical device that analyzes retinal images to assist in diagnosing eye diseases and predicts the risk of cardiovascular disease with accuracy comparable to cardiac CT. It is a retinal AI solution that integrates the domestically distributed eye disease diagnosis support software 'DrNoon Fundus' and the cardiovascular risk assessment software 'DrNoon CVD' into a single product.

Through this CE MDR certification, Mediwale has established a regulatory foundation to sell and supply DrNoon in all 27 European Union (EU) member states. At the same time, the company has demonstrated its global regulatory competitiveness by meeting Europe's strengthened medical device standards in the field of retinal AI.

In particular, this certification is significant in that it was granted for a 'predictive' purpose, which remains rare even under the stringent European MDR system. With this achievement, Mediwale has objectively proven the unique differentiation of DrNoon in the medical AI market, which has traditionally been limited to disease diagnosis support.

Mediwale expects this accomplishment to further enhance product credibility in discussions with overseas medical institutions and partners. Choi Taegeun, CEO of Mediwale, stated, "The fact that 'cardiovascular risk prediction' was specified as the intended use of DrNoon in this certification is an important achievement that demonstrates our differentiated approach of evaluating systemic disease risk based on retinal AI. Building on this, we will accelerate the expansion of clinical application in Europe and strengthen global partnerships to scale up our market presence."

This content was produced with the assistance of AI translation services.