VUNO’s achievement of CE MDR and UKCA certifications for its AI-powered cardiac arrest prediction system, DeepCARS®, marks a major milestone in advancing the global application of artificial intelligence in critical care. These certifications confirm that the solution meets rigorous safety and efficacy standards required in the European Union and the United Kingdom, opening up access to two of the world’s most regulated and influential medical device markets. By achieving these certifications more than a year ahead of schedule, VUNO positions itself as a front-runner in bringing AI-driven risk management tools to international hospitals, addressing a critical need for early cardiac arrest detection in clinical settings.

The significance of this development is amplified by VUNO’s strategic plan to expand into both European and Middle Eastern markets through collaboration with experienced regional partners. The CE MDR and UKCA approvals serve not only as regulatory green lights but also as endorsements that facilitate smoother adoption, hospital integration, and potential reimbursement. Furthermore, as CE and FDA standards are often referenced in Middle Eastern regulatory frameworks, this milestone accelerates VUNO’s pathway toward establishing DeepCARS as a trusted solution across new geographies, ultimately aiming to begin full-scale operations in the Middle East by 2026.

In conclusion, the international recognition of DeepCARS highlights both the growing trust in AI-based healthcare solutions and the urgent demand for technologies that can improve patient outcomes in emergency and critical care. With a strong clinical foundation already demonstrated in over 130 South Korean hospitals, VUNO is now poised to scale its impact globally. These certifications not only enhance the company’s credibility but also reaffirm the essential role that predictive analytics and real-time monitoring will play in the future of hospital care worldwide.

MedTech Spectrum's Summary

Global Regulatory Milestone: VUNO's AI-powered cardiac arrest risk management system, DeepCARS®, has earned CE MDR certification in the EU and UKCA certification in the UK, enabling early international expansion.

Market Expansion Strategy: The company plans to leverage these certifications to enter European and Middle Eastern markets through partnerships with regional healthcare providers and complete key registrations by 2026.

Proven Clinical Track Record: Already used in over 130 South Korean hospitals, DeepCARS® is positioned to improve patient safety globally through early cardiac arrest prediction and AI-driven critical care support.