South Korean medical AI company VUNO announced that its flagship product VUNO Med-DeepCARS has received CE MDR certification in the European Union and UKCA mark in the United Kingdom, significantly accelerating the company's global expansion plans. The AI-powered system, which predicts the risk of in-hospital cardiac arrest within 24 hours by analyzing patient vital signs, achieved these regulatory milestones more than a year ahead of schedule.
The CE MDR certification validates the clinical safety and effectiveness of VUNO's solution across all 27 EU member states, opening immediate pathways for European market entry. The company plans to partner with established local AI healthcare organizations that have experience introducing similar technologies to hospitals in the region.
"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."
Technology and Clinical Implementation
VUNO Med-DeepCARS is designed to monitor patients in general hospital wards by analyzing vital signs including blood pressure, heart rate, respiratory rate, and body temperature to predict cardiac arrest risk within the next 24 hours. This early warning system enables medical staff to intervene before critical deterioration occurs.
As of April 2025, the system has been implemented across more than 48,000 hospital beds in South Korea, including over 20 tertiary general hospitals. The widespread adoption in its home market demonstrates the system's clinical utility and integration capabilities with existing hospital workflows.
Global Expansion Strategy
With these certifications secured, VUNO is executing a two-pronged international expansion strategy. In Europe, the company will work with experienced local partners to navigate hospital adoption and reimbursement processes, which vary significantly across different healthcare systems.
Simultaneously, VUNO is preparing to enter Middle Eastern markets, where CE MDR certification is widely recognized as a key reference in regulatory processes. The company aims to complete regulatory registrations in key Middle Eastern countries within 2025 and begin full-scale operations across the region by 2026.
Regulatory Momentum
The CE MDR and UKCA certifications add to VUNO's growing list of regulatory achievements. In 2023, DeepCARS received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA), a program designed to expedite the development and review of medical devices that provide more effective treatment or diagnosis of life-threatening conditions.
The FDA approval process for DeepCARS is currently underway, which would open access to the world's largest healthcare market. The company's ability to secure multiple major regulatory approvals suggests strong clinical validation of its AI technology.
About VUNO
Founded in 2014, VUNO has established itself as a pioneer in medical AI applications. The company developed South Korea's first approved AI-powered medical device and has since expanded its technology to analyze various medical data types, including bio signals like ECG and respiratory rate, as well as medical images such as X-rays, CT scans, and fundus images.
VUNO's mission centers on making high-quality healthcare more accessible worldwide through AI-driven solutions that support clinical decision-making and improve patient outcomes. The company's success with DeepCARS demonstrates the growing acceptance of AI tools in critical care settings and their potential to transform healthcare delivery globally.
