- Early Regulatory Approval Accelerates Expansion Plans in Europe and the Middle East
SEOUL, South Korea, May 12, 2025 /PRNewswire/ — 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.”
About VUNO Med®-DeepCARS®
VUNO Med®-DeepCARS®(DeepCARS) is an AI-powered medical device designed to monitor the risk of in-hospital cardiac arrest within the next 24 hours. It analyzes patients’ vital signs-including blood pressure, heart rate, respiratory rate, and body temperature-in general wards.
As of April 2025, DeepCARS has been implemented across more than 48,000 hospital beds in South Korea, including over 20 tertiary general hospitals, establishing itself as an essential part of care. In 2023, DeepCARS received Breakthrough Device Designation (BDD) from the U.S. Food and Drug Administration (FDA) and is currently undergoing the FDA approval process.
About VUNO
VUNO, founded in 2014, is a leading South Korean medical AI company and the developer of the nation’s first approved AI-powered medical device. Leveraging cutting-edge AI technology, VUNO analyzes a wide range of medical data — from bio signals such as ECG, respiratory rate and blood pressure to medical images including X-rays, CT scans, and fundus images — to predict critical events and support clinicians in decision-making.
Committed to patient-centered innovation, VUNO strives to make high-quality healthcare accessible to everyone, worldwide.
