#South Korea #Seoul #Medical AI #VUNO #DeepCARS

VUNO's AI-Driven Cardiac Arrest Risk Management: A New Era in Patient Care

In an impressive milestone for healthcare technology, VUNO, a prominent South Korean medical AI firm, has announced that its flagship product, the AI-powered cardiac arrest risk management system, VUNO Med®-DeepCARS®, has successfully obtained CE MDR (Medical Device Regulation) certification in the European Union and UKCA (UK Conformity Assessed) mark in the United Kingdom. This achievement not only underscores the safety and effectiveness of DeepCARS but also accelerates VUNO's plans for expansion into European and Middle Eastern markets.

Accelerated Global Reach

VUNO's rapid certification approval has come more than a year ahead of schedule, significantly enhancing the company’s ability to penetrate global markets. With the CE MDR certification validating DeepCARS' efficacy across the 27 EU member states, VUNO is poised to begin collaborations with local AI healthcare partners. These partners will play a crucial role in facilitating the adoption of DeepCARS within hospitals, ensuring a smooth reimbursement process that will enhance its integration into healthcare systems.

Additionally, VUNO intends to explore entry into the Middle Eastern healthcare market where CE MDR and U.S. FDA certifications often serve as essential references during regulatory evaluations, simplifying the path to market introduction. By leveraging its now established CE MDR certification, VUNO plans to finalize regulatory registrations in key Middle Eastern nations within the year, aiming to commence extensive operations by 2026.

Testimonials from Leadership

Dr. Ye Ha Lee, the Founder and CEO of VUNO, emphasized the significance of 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. DeepCARS is already being used in over 130 hospitals across South Korea, and we are confident in its potential to contribute to patient safety globally."

DeepCARS: Function and Impact

VUNO Med®-DeepCARS® is a pioneering AI-powered medical device that identifies patients at risk of experiencing an in-hospital cardiac arrest within the following 24 hours. It achieves this by analyzing crucial vital signs, such as blood pressure, heart rate, respiratory rate, and body temperature, in general wards. As of April 2025, DeepCARS has been integrated across more than 48,000 hospital beds in South Korea, including over 20 tertiary general hospitals. This successful implementation cements DeepCARS as an indispensable tool in patient care.

Furthermore, in a significant development for its U.S. market ambitions, DeepCARS received Breakthrough Device Designation (BDD) from the U.S. Food and Drug Administration (FDA) in 2023, signaling its status as a transformative innovation. It is currently engaged in the FDA approval process, marking another critical point in VUNO's strategy.

About VUNO

Founded in 2014, VUNO has emerged as a leader in South Korea’s medical AI space, responsible for developing the nation’s first approved AI-powered medical device. The company harnesses advanced AI technology to analyze a diverse array of medical data—ranging from bio signals like ECG, respiratory rates, and blood pressure, to medical imaging data including X-rays and CT scans. VUNO’s commitment to innovation reflects its overarching goal: to make high-quality healthcare accessible to individuals around the world.

As the global healthcare landscape continues to evolve, VUNO's advancements in AI technology suggest a promising future for enhanced patient care, emphasizing timely and effective interventions that could save lives. The company stands at the forefront of a transformative era in healthcare, driven by the potential of artificial intelligence to mitigate risks and improve clinical outcomes.