Latest news with #CEMDR
Korea Herald
6 days ago
- Health
- Korea Herald
Lunit Launches Enhanced Lunit INSIGHT CXR4, Secures CE MDR Certification for Expanded AI Capabilities
Next-generation AI solution introduces new clinical features and broader disease detection for chest X-rays SEOUL, South Korea, May 28, 2025 /PRNewswire/ -- Lunit (KRX: a leading provider of AI for cancer diagnostics and therapeutics, today announced the official launch and CE certification under the Medical Device Regulation (MDR) of Lunit INSIGHT CXR4, its next-generation chest X-ray analysis solution. Lunit INSIGHT CXR4 is a comprehensive AI solution for chest imaging, designed to support radiologists across a wide range of clinical scenarios. It leverages advanced AI to detect 12 types of chest abnormalities—including lung nodules, pneumonia, and pneumothorax—expanding its diagnostic capabilities to include additional findings such as acute bone fractures. Trained on large-scale real-world datasets, the upgraded solution delivers improved diagnostic accuracy while supporting early detection of critical diseases. In addition to expanded disease detection, Lunit INSIGHT CXR4 introduces several new features designed to enhance clinical workflow and diagnostic support: With CE MDR certification, Lunit is now positioned to deploy INSIGHT CXR4 across Europe—offering enhanced diagnostic confidence and workflow efficiency for radiologists managing high imaging volumes. "With Lunit INSIGHT CXR4, we've gone beyond expanding detection—we've focused on what truly helps clinicians in their day-to-day workflow," said Brandon Suh, CEO of Lunit. "Features like active normal flagging and current-prior comparison are designed to reduce reading time and improve triage confidence, especially in high-volume settings. CE MDR certification is a key step toward broader adoption, and we're committed to bringing CXR4 to more hospitals worldwide." With CE MDR certification now in place, Lunit is preparing to pursue additional regulatory approvals to make CXR4 available in more regions. The company aims to further integrate its AI solutions into clinical workflows across diverse healthcare systems. CE MDR is the EU's enhanced regulatory standard for medical devices, ensuring stricter standards for safety, performance, and clinical validation. About Lunit Founded in 2013, Lunit (KRX: is a global leader in AI for cancer diagnostics and therapeutics. With a mission to conquer cancer through AI, Lunit develops AI-powered solutions for medical imaging and biomarker analysis to enable precise diagnosis and personalized treatment. Lunit's FDA-cleared Lunit INSIGHT suite supports cancer screening at over 4,800 medical institutions in more than 55 countries. Lunit clinical studies have been featured in top-tier journals—including The Lancet Digital Health and Journal of Clinical Oncology —and presented at major conferences such as ASCO and RSNA. Headquartered in Seoul with global offices, Lunit is driving the worldwide fight against cancer. Learn more at
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
12-02-2025
- Health
- Yahoo
QuantalX Neuroscience Announces CE MDR Approval, Making Brain Health Assessment Available in the EU
The company announces CE MDR approval for its novel Delphi-MD neurodiagnosis medical device in preparation for EU commercialization, improving patients' clinical outcomes and well being while reducing healthcare systems and payors' financial burden. NEW YORK, Feb. 12, 2025 /PRNewswire/ -- QuantalX Neuroscience Ltd. is proud to announce that its groundbreaking brain health assessment device, the Delphi-MD, has received CE MDR approval, the European Union's certification under the new Medical Device Regulation (MDR). The CE MDR certification process sets a new benchmark for safety, efficacy, and quality in medical devices. This achievement underscores QuantalX's commitment to innovation and excellence in neurological care. With CE MDR approval, QuantalX is set to scale the commercialization of its accessible and objective neurodiagnosis test across Europe. The Delphi-MD device will be deployed in neurological care centers, neurology departments, and brain health networks. Delphi-MD will streamline improved brain health assessment, early detection and differential diagnosis of any brain abnormality or disease such as stroke, Parkinson disease, dementia, Alzheimer's disease, Normal Pressure Hydrocephalous (NPH) and more, as well as prediction of individual patients' treatment response. The aging population in Europe is driving a sharp rise in neurodegenerative diseases such as dementia, Parkinson's, and stroke. According to the World Health Organization (WHO), caring for the 14.1 million people living with dementia in Europe cost $439 billion in 2019, averaging $31,144 (€27,815) per patient. Parkinson's disease, the fastest-growing neurological disorder, affects over 1.2 million people across Europe, with cases expected to rise as the population ages. By 2050, the number of Europeans aged 60 and older is projected to increase significantly, further straining healthcare systems and highlighting the urgent need for advanced care solutions. Dr. Iftach Dolev, CEO and Co-founder of QuantalX, shared his thoughts on this landmark achievement: "CE MDR approval validates the unparalleled innovation behind our neurodiagnosis test. It's a testament to our team's dedication and marks the beginning of a new era in brain health diagnostics." With its ability to enable early detection and precise diagnosis of neurological disorders, Delphi-MD will play a crucial role in improving patient outcomes and quality of life while alleviating the growing economic and clinical burden on Europe's healthcare systems. About QuantalX Neuroscience QuantalX is committed to fundamentally improving patient care and alleviating the burden on healthcare systems through objective and accurate, early detection and differential diagnosis of brain abnormalities, leveraging its novel Direct Neuro-Physiological technology, the Delphi-MD device. Media Contact:Adi JacobsonVP Marketing, QuantalX NeuroscienceAdi@ +972502043934 Photo - View original content to download multimedia: SOURCE QuantalX Sign in to access your portfolio
