Mediwhale said Wednesday that its retinal AI solution, Dr. Noon, has obtained certification under the European Union’s Medical Device Regulation (CE MDR).
CE MDR is the European Union’s regulatory framework governing the marketing and distribution of medical devices. Introduced in 2021 to replace the previous Medical Device Directive (MDD), the framework imposes stricter requirements on product safety, clinical evidence, quality management systems and post-market surveillance.
Mediwhale’s Dr. Noon (Courtesy of Mediwhale)
Dr. Noon is an AI-based medical device that analyzes retinal images to assist in diagnosing eye diseases and predicting cardiovascular disease risk with accuracy comparable to cardiac CT scans. The solution integrates two existing products currently available in Korea -- Dr. Noon Fundus, an ophthalmic diagnostic support software, and Dr. Noon CVD, a cardiovascular risk assessment tool, into a unified retinal AI platform.
With the CE MDR certification, Mediwhale has secured the regulatory basis to commercialize Dr. Noon across all 27 member states of the European Union. The company said the approval demonstrates Dr. Noon’s compliance with Europe’s strengthened regulatory standards for retinal AI, highlighting its global competitiveness in medical device authorization.
Notably, the certification is particularly significant because it was granted for a “predictive” purpose -- an uncommon case under the stringent MDR framework. The company said this distinction highlights Dr. Noon’s differentiation in a medical AI market that has traditionally focused on diagnostic assistance.
Mediwhale expects the achievement to enhance confidence in its product among overseas healthcare providers and potential partners. The company also anticipates accelerated progress in its global regulatory strategy, supported by both the CE MDR certification and its ongoing U.S. approval process through the FDA De Novo pathway.
Mediwhale CEO Choi Tae-geun said, “The explicit recognition of ‘cardiovascular risk prediction’ as an intended use in this certification is a meaningful milestone that demonstrates our differentiated approach -- assessing systemic disease risk based on retinal AI.”
He added that the company aims to expand clinical adoption in Europe and accelerate market growth through stronger global partnerships.
Mediwhale is actively advancing the global expansion and commercialization of Dr. Noon. Dr. Noon CVD is currently undergoing FDA De Novo approval, while its follow-up pipeline, Dr. Noon CKD, a retinal AI-based solution for predicting chronic kidney disease, has completed an application for approval with the Ministry of Food and Drug Safety.
Leveraging the progress of its key pipelines, Mediwhale is also moving forward with plans for a Kosdaq listing under the technology special track, the company added.
Kim Ji-hye
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