Information Technology
VUNO's AI-Powered Cardiac Arrest Risk Management System Earns CE MDR and UKCA Certifications
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 . "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."
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.
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.
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