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.