#AI #South Korea #Seoul #VUNO #DeepCARS

VUNO's Path to Global Expansion

VUNO, a prominent medical AI enterprise from South Korea, is taking significant strides in the healthcare space with its flagship product, VUNO Med®-DeepCARS®. This advanced AI-powered cardiac arrest risk management system has recently earned the CE MDR (Medical Device Regulation) certification in the European Union and the UKCA (UK Conformity Assessed) mark in the United Kingdom. These certifications, obtained more than a year in advance of the expected timeline, not only underscore the efficacy and safety of the system but also pave the way for accelerated market entry into the European landscape.

With the CE MDR certification, VUNO is positioned to capitalize on the healthcare segments across the 27 member states of the EU. The approval signifies that VUNO Med®-DeepCARS® meets the high standards required for medical devices, which will bolster their marketing and operational strategies within Europe. VUNO aims to collaborate with established local partners who have a successful track record of guiding technology adoption within the healthcare sector to facilitate smoother hospital integration and reimbursement methodologies.

Additionally, VUNO is gearing up for entry into the Middle Eastern markets, where both the CE MDR and U.S. FDA certifications are often seen as instrumental benchmarks in regulatory processes. The company is optimistic about completing its regulatory registrations across pivotal nations in the region within this year and is targeting a full-scale operational debut by 2026.

Dr. Ye Ha Lee, VUNO's Founder and CEO, expressed his enthusiasm regarding this achievement, stating, "This milestone marks a pivotal step in VUNO's mission to bring AI-driven innovation in critical care to the global stage." With operations already spanning 130+ hospitals in South Korea, DeepCARS has a successful implementation history that VUNO believes will translate effectively in international markets, ultimately improving patient safety throughout healthcare facilities worldwide.

What Is VUNO Med®-DeepCARS®?

VUNO Med®-DeepCARS® stands as a significant advancement in medical technology, crafted to monitor the potential risk of cardiac arrest for patients over a span of 24 hours. The technology assesses key vital signs—including blood pressure, heart rate, respiratory rate, and body temperature—within general ward settings in hospitals. As of April 2025, it has been adopted in over 48,000 hospital beds across South Korea, including more than 20 tertiary general hospitals, indicating its critical role in patient care protocols.

Excitingly, DeepCARS secured the Breakthrough Device Designation (BDD) from the U.S. Food and Drug Administration (FDA) in 2023 and is currently navigating the process of formal FDA approval. This regulatory acknowledgment affirms its innovative nature and the enormous potential it has to enhance patient outcomes in critical medical scenarios.

About VUNO

Founded in 2014, VUNO has rapidly established itself as a leader in the South Korean medical AI sector. It boasts the development of the nation's first ratified AI-powered medical device and continues to leverage cutting-edge AI to analyze a diverse array of medical datasets. From interpreting bio-signals like ECG and blood pressure to analyzing imaging diagnostics such as CT scans and X-rays, VUNO is at the forefront of enhancing clinical decision-making.

VUNO is deeply committed to patient-centered innovations, striving to render high-quality healthcare accessible and effective across the globe. This commitment is further exemplified in its strategic moves towards expanding its footprint beyond South Korea, aiming to improve healthcare practices around the world.