South Korean company VUNO’s Med-DeepCARS (DeepCARS) solution has secured CE MDR certification in the European Union (EU), along with the UK Conformity Assessed (UKCA) mark, for in-hospital cardiac arrest risk monitoring.
These approvals, obtained over a year ahead of schedule, position the company for an expedited entry into worldwide markets.
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Comprising an AI-powered cardiac arrest risk management system, DeepCARS is designed to monitor the risk within the next 24 hours by analysing the crucial signs of the patients in general wards, including respiratory rate, heart rate, body temperature and blood pressure.
The EU certification confirms the system’s clinical safety across the 27 member states, facilitating VUNO’s expansion in Europe.
The company noted that it plans to collaborate with local AI healthcare partners who have launched similar technologies for streamlining reimbursement processes and hospital adoption.
In parallel, the company is setting its sights on entering the Middle Eastern market
VUNO CEO and founder Dr 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.”
With the CE MDR certification secured, VUNO is targeting the completion of regulatory registrations in prime Middle Eastern nations within the year and will commence full-scale operations in the region by 2026.
VUNO noted that as of April this year, the system has been implemented across over 48,000 hospital beds in South Korea, including more than 20 tertiary general hospitals.
DeepCARS secured the US Food and Drug Administration’s (FDA) breakthrough device designation in 2023 and is currently in the agency’s approval process.
