VUNO has secured both the CE MDR certification in the European Union (EU) and the UKCA mark (UK Conformity Assessed) in the UK for VUNO Med-DeepCARS, its artificial intelligence (AI)-driven cardiac arrest risk management tool.
VUNO Med-DeepCARS is designed to assess the risk of in-hospital cardiac arrest over a 24-hour period by evaluating patient vital signs such as blood pressure, heart rate, respiratory rate, and body temperature in general wards.
According to the South Korean medical AI firm, these certifications, attained well ahead of the anticipated timeline, facilitate its swift entry into international markets.
The CE MDR certification ensures VUNO’s system meets clinical safety and efficacy standards within the 27 EU member states, allowing VUNO to expand its presence across Europe. The company plans to work with seasoned local AI healthcare partners to facilitate hospital adoption and reimbursement processes.
Additionally, VUNO is poised to penetrate the Middle Eastern market. Here, CE MDR and the US Food and Drug Administration (FDA) certifications play a crucial role in regulatory acceptance, paving a smoother path for market entry.
With CE MDR approval secured, VUNO intends to finalise regulatory registrations in key Middle Eastern nations by the end of the year and commence full-scale operations by 2026.
VUNO founder and CEO Ye Ha Lee said: “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. With this proven track record, we are confident in its potential to contribute to patient safety in hospitals around the world.”
By April 2025, DeepCARS is claimed to have been adopted by over 48,000 hospital beds in South Korea, including more than 20 major hospitals, establishing itself as an integral component of patient care. In 2023, it received breakthrough device designation from the FDA and is awaiting the US regulator’s approval.
