Mediwhale, a medical artificial intelligence (AI) company, announced on Wednesday that its retinal AI solution, DrNoon, has received Medical Device Regulation (CE MDR) certification under European medical device regulations.
DrNoon is an innovative AI medical device that analyzes retinal images to assist in diagnosing eye diseases and predicts cardiovascular disease risks with accuracy comparable to heart computed tomography (CT) scans. This comprehensive retinal AI solution combines two software products currently available in South Korea: DrNoon Fundus for eye disease diagnostic support and DrNoon CVD for cardiovascular risk assessment.
The CE MDR certification allows Mediwhale to market and distribute DrNoon across all 27 European Union (EU) member states. By meeting Europe’s stringent medical device standards, DrNoon has proven its global regulatory competitiveness in the retinal AI sector.
Notably, this certification is particularly significant as it was granted for predictive purposes, a rare achievement under the rigorous European MDR framework.
Mediwhale sees this as concrete validation of DrNoon’s unique position in the medical AI market, which has traditionally focused on disease diagnosis assistance.
The company anticipates that this accomplishment will bolster product credibility in discussions with international healthcare providers and potential partners.
Furthermore, securing both the European CE MDR certification and progressing through the U.S. Food and Drug Administration’s (FDA) De Novo process in the U.S. is expected to accelerate DrNoon’s global regulatory strategy.
Choi Tae-geun, Chief Executive Officer (CEO) of Mediwhale, emphasized that having cardiovascular risk prediction explicitly stated as DrNoon’s intended use in this certification is a crucial milestone. It underscores the innovative approach to assessing systemic disease risks using retinal AI. He added that it’ll leverage this achievement to expand the presence in European healthcare settings and strengthen global partnerships, driving the market expansion efforts.
Mediwhale, founded in 2016, specializes in developing medical AI software that predicts the risk of cardiovascular and metabolic diseases, including cardiovascular diseases and chronic kidney disease, using retinal imaging and artificial intelligence technology.
The company pioneered the development and commercialization of DrNoon CVD, the world’s first AI solution that analyzes cardiovascular disease risks with accuracy comparable to traditional heart CT scans.
Mediwhale claims a significant competitive edge by delivering results within minutes through simple, radiation-free eye examinations. The technology is currently employed in over 170 medical institutions worldwide.