Latest news with #DeepCARS
Korea Herald
5 days ago
- Business
- Korea Herald
VUNO Showcases DeepCARS® at AACN NTI 2025, Highlighting AI-Driven Cardiac Arrest Risk Prediction
– Company engages U.S. critical care professionals with data-driven early warning solution MARLBOROUGH, Mass., May 26, 2025 /PRNewswire/ -- VUNO, a global medical AI company, presented its flagship solution VUNO Med ® –DeepCARS ® at the 2025 National Teaching Institute & Critical Care Exposition (NTI), hosted by the American Association of Critical-Care Nurses (AACN), from May 19–21 at the Ernest N. Morial Convention Center in New Orleans. DeepCARS is an AI-powered medical device that predicts an inpatient's risk of in-hospital cardiac arrest within the next 24 hours. By continuously analyzing patients' vital signs—such as blood pressure, heart rate, respiratory rate, and body temperature— the solution enables timely clinical intervention in general wards. "Collaborating with AACN members has reaffirmed how DeepCARS can meaningfully contribute to both hospital efficiency and patient safety—empowering clinicians with timely insights that lead to proactive, life-saving care," said Robert Tingley, Vice President of Business Development at VUNO. "We sincerely thank the critical care community for their thoughtful engagement and valuable insight." At AACN NTI 2025, VUNO's booth drew significant attention from clinical professionals, particularly members of Rapid Response Teams (RRTs) seeking innovative tools to detect patient deterioration earlier and respond more effectively. The VUNO team—including Robert Tingley, Andrew Abbring (Area Sales Director), and Tae Min Son (Director of Product Management)—engaged with healthcare stakeholders to better understand the needs and workflows of U.S. hospitals. DeepCARS has been adopted across more than 48,000 hospital beds in South Korea, including 20 tertiary general hospitals, making it a critical component of routine care. In 2023, the solution received Breakthrough Device Designation (BDD) from the U.S. Food and Drug Administration (FDA) and is currently undergoing the FDA 510(k) clearance process. As the company strengthens its presence in the U.S. market, it continues to focus on working closely with healthcare providers to ensure successful integration into existing clinical workflows and environments. About VUNO Founded in Seoul in 2014, VUNO is a global medical AI company and the developer of the nation's first approved AI-powered medical device. Leveraging cutting-edge AI technology, VUNO analyzes a wide range of medical data—from bio signals such as ECG, respiratory rate and blood pressure to medical images including X-rays, CT scans, and fundus images—to predict critical events and support clinicians in decision-making. Committed to patient-centered innovation, VUNO strives to make high-quality healthcare accessible to everyone, worldwide.
Korea Herald
12-05-2025
- Business
- Korea Herald
VUNO's AI-Powered Cardiac Arrest Risk Management System Earns CE MDR and UKCA Certifications
SEOUL, South Korea, May 12, 2025 /PRNewswire/ -- VUNO, a leading South Korean medical AI company, announced today that its flagship AI-powered cardiac arrest risk management system VUNO Med®-DeepCARS®(DeepCARS) has received CE MDR (Medical Device Regulation) certification in the European Union, as well as the UKCA (UK Conformity Assessed) mark in the United Kingdom. Achieving these regulatory milestones more than a year ahead of schedule significantly accelerates the company's global market entry. The CE MDR certification affirms the clinical safety and effectiveness of VUNO's solution across the 27 EU member states, enabling the company to actively pursue expansion in European markets. VUNO plans to collaborate with experienced local AI healthcare partners who have successfully introduced similar solutions in the region to streamline hospital adoption and reimbursement processes. Simultaneously, VUNO is preparing to enter the Middle Eastern market, where CE MDR and U.S. FDA certifications are commonly recognized as key references in the regulatory process, supporting a smoother pathway to market entry. With CE MDR in hand, the company aims to complete regulatory registrations in key Middle Eastern countries within the year and initiate full-scale operations across the region by 2026. "This milestone marks a pivotal step in VUNO's mission to bring AI-driven innovation in critical care to the global stage," said Dr. Ye Ha Lee, Founder & CEO of VUNO. "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." About VUNO Med ® -DeepCARS ® VUNO Med®-DeepCARS®(DeepCARS) is an AI-powered medical device designed to monitor the risk of in-hospital cardiac arrest within the next 24 hours. It analyzes patients' vital signs-including blood pressure, heart rate, respiratory rate, and body temperature-in general wards. As of April 2025, DeepCARS has been implemented across more than 48,000 hospital beds in South Korea, including over 20 tertiary general hospitals, establishing itself as an essential part of care. In 2023, DeepCARS received Breakthrough Device Designation (BDD) from the U.S. Food and Drug Administration (FDA) and is currently undergoing the FDA approval process. About VUNO VUNO, founded in 2014, is a leading South Korean medical AI company and the developer of the nation's first approved AI-powered medical device. Leveraging cutting-edge AI technology, VUNO analyzes a wide range of medical data — from bio signals such as ECG, respiratory rate and blood pressure to medical images including X-rays, CT scans, and fundus images — to predict critical events and support clinicians in decision-making. Committed to patient-centered innovation, VUNO strives to make high-quality healthcare accessible to everyone, worldwide.
Yahoo
12-05-2025
- Business
- Yahoo
VUNO's AI-Powered Cardiac Arrest Risk Management System Earns CE MDR and UKCA Certifications
Early Regulatory Approval Accelerates Expansion Plans in Europe and the Middle East SEOUL, South Korea, May 12, 2025 /PRNewswire/ -- VUNO, a leading South Korean medical AI company, announced today that its flagship AI-powered cardiac arrest risk management system VUNO Med®-DeepCARS®(DeepCARS) has received CE MDR (Medical Device Regulation) certification in the European Union, as well as the UKCA (UK Conformity Assessed) mark in the United Kingdom. Achieving these regulatory milestones more than a year ahead of schedule significantly accelerates the company's global market entry. The CE MDR certification affirms the clinical safety and effectiveness of VUNO's solution across the 27 EU member states, enabling the company to actively pursue expansion in European markets. VUNO plans to collaborate with experienced local AI healthcare partners who have successfully introduced similar solutions in the region to streamline hospital adoption and reimbursement processes. Simultaneously, VUNO is preparing to enter the Middle Eastern market, where CE MDR and U.S. FDA certifications are commonly recognized as key references in the regulatory process, supporting a smoother pathway to market entry. With CE MDR in hand, the company aims to complete regulatory registrations in key Middle Eastern countries within the year and initiate full-scale operations across the region by 2026. "This milestone marks a pivotal step in VUNO's mission to bring AI-driven innovation in critical care to the global stage," said Dr. Ye Ha Lee, Founder & CEO of VUNO. "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." About VUNO Med®-DeepCARS® VUNO Med®-DeepCARS®(DeepCARS) is an AI-powered medical device designed to monitor the risk of in-hospital cardiac arrest within the next 24 hours. It analyzes patients' vital signs-including blood pressure, heart rate, respiratory rate, and body temperature-in general wards. As of April 2025, DeepCARS has been implemented across more than 48,000 hospital beds in South Korea, including over 20 tertiary general hospitals, establishing itself as an essential part of care. In 2023, DeepCARS received Breakthrough Device Designation (BDD) from the U.S. Food and Drug Administration (FDA) and is currently undergoing the FDA approval process. About VUNO VUNO, founded in 2014, is a leading South Korean medical AI company and the developer of the nation's first approved AI-powered medical device. Leveraging cutting-edge AI technology, VUNO analyzes a wide range of medical data — from bio signals such as ECG, respiratory rate and blood pressure to medical images including X-rays, CT scans, and fundus images — to predict critical events and support clinicians in decision-making. Committed to patient-centered innovation, VUNO strives to make high-quality healthcare accessible to everyone, worldwide. View original content: SOURCE VUNO Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
