VUNO's AI Cardiac Risk System Gains EU and UK Certifications

VUNO has announced that its AI-powered cardiac arrest risk management system, VUNO Med-DeepCARS, has received CE MDR certification in the European Union and the UKCA mark in the United Kingdom, as stated in a press release. These certifications, achieved ahead of schedule, will facilitate VUNO's expansion into European and Middle Eastern markets.

The CE MDR certification confirms the clinical safety and effectiveness of DeepCARS across the 27 EU member states, allowing VUNO to pursue partnerships with local AI healthcare providers to enhance hospital adoption and reimbursement processes. In the Middle East, where CE MDR and U.S. FDA certifications are key regulatory references, VUNO plans to complete registrations in key countries by the end of the year and begin full-scale operations by 2026.

DeepCARS is designed to monitor the risk of in-hospital cardiac arrest within 24 hours by analyzing vital signs such as blood pressure, heart rate, respiratory rate, and body temperature. It is already implemented in over 130 hospitals in South Korea, covering more than 48,000 hospital beds.