VUNO, a leading South Korean medical AI company, announced today that its flagship AI-powered cardiac arrest risk management system VUNO Med®-DeepCARS®(DeepCARS) has received CE MDR (Medical Device Regulation) certification in the European Union, as well as the UKCA (UK Conformity Assessed) mark in the United Kingdom. Achieving these regulatory milestones more than a year ahead of schedule significantly accelerates the company’s global market entry.
The CE MDR certification affirms the clinical safety and effectiveness of VUNO’s solution across the 27 EU member states, enabling the company to actively pursue expansion in European markets. VUNO plans to collaborate with experienced local AI healthcare partners who have successfully introduced similar solutions in the region to streamline hospital adoption and reimbursement processes.
Simultaneously, VUNO is preparing to enter the Middle Eastern market, where CE MDR and U.S. FDA certifications are commonly recognized as key references in the regulatory process, supporting a smoother pathway to market entry. With CE MDR in hand, the company aims to complete regulatory registrations in key Middle Eastern countries within the year and initiate full-scale operations across the region by 2026.
“This milestone marks a pivotal step in VUNO’s mission to bring AI-driven innovation in critical care to the global stage,” said Dr. Ye Ha Lee, Founder & CEO of VUNO. “DeepCARS is already being used in over 130 hospitals across South Korea. With this proven track record, we are confident in its potential to contribute to patient safety in hospitals around the world.”
