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Lunit Launches Enhanced Lunit INSIGHT CXR4, Secures CE MDR Certification for Expanded AI Capabilities
Lunit Launches Enhanced Lunit INSIGHT CXR4, Secures CE MDR Certification for Expanded AI Capabilities

Korea Herald

time28-05-2025

  • 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

Lunit Surpasses 1 Million Mammograms in U.S. One Year After Volpara Acquisition
Lunit Surpasses 1 Million Mammograms in U.S. One Year After Volpara Acquisition

Korea Herald

time19-05-2025

  • Business
  • Korea Herald

Lunit Surpasses 1 Million Mammograms in U.S. One Year After Volpara Acquisition

Building on Volpara's breast health expertise, Lunit strengthens its U.S. presence—now delivering AI-powered breast cancer screening across 200 imaging sites SEOUL, South Korea, May 19, 2025 /PRNewswire/ -- Lunit (KRX: a leading provider of AI for cancer diagnostics and therapeutics, today announced major milestones in the United States, one year after its acquisition of Volpara Health Technologies. Since acquiring Volpara, Lunit has significantly expanded its presence across North America. By June 2025, Lunit's AI solutions for digital breast tomosynthesis (Lunit INSIGHT DBT) and mammography analysis (Lunit INSIGHT MMG) will be deployed at over 200 imaging centers and hospitals across the U.S., with approximately 350 to 400 radiologists utilizing its technology. Together, Lunit and Volpara now power more than one million annual mammograms across North America — a major step forward in the company's U.S. growth strategy. Lunit's growing customer base includes leading healthcare providers such as Rezolut, SimonMed Imaging, and UC Davis Health, reflecting its strengthening position in the U.S. medical imaging market. In addition to its expanding U.S. footprint, Lunit and Volpara introduced the concept of a comprehensive Ecosystem for Cancer Detection and Care at RSNA 2024. The Ecosystem is designed to unify AI technologies for lesion detection, workflow optimization, quality control, and patient engagement—empowering clinicians with actionable insights and scalable solutions across the cancer care continuum. Lunit and Volpara also demonstrated the complementary value of combining Lunit INSIGHT Risk and Volpara Risk Pathways at RSNA 2024—offering a glimpse into how imaging-based and clinical data may be used together to personalize breast cancer risk assessment. The two solutions were shown as a prototype to work in tandem, that would predict the likelihood of breast cancer development within 1 to 5 years, to enable earlier interventions, more personalized care, and redefine standards for breast cancer screening and management. "The successful integration of Lunit and Volpara has accelerated our mission to transform cancer diagnostics globally, and the momentum we've built in the United States marks just the beginning," said Brandon Suh, CEO of Lunit. "By combining Lunit's AI innovation with Volpara's breast health expertise, we're delivering a new standard of comprehensive support for clinicians—enhancing early detection, improving screening quality, optimizing workflows, and ultimately helping providers deliver better outcomes for patients worldwide. With our expanded footprint and comprehensive ecosystem, we are poised to lead the future of cancer care." Lunit plans to further expand its U.S. operations, building on its strong foundation with next-generation AI solutions, dedicated clinical support, and a growing ecosystem designed to shape the future of cancer detection and care. 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

Lunit to Power Germany's Largest Private Radiology Network with AI Imaging
Lunit to Power Germany's Largest Private Radiology Network with AI Imaging

Korea Herald

time07-05-2025

  • Business
  • Korea Herald

Lunit to Power Germany's Largest Private Radiology Network with AI Imaging

The five-year framework agreement covers phased rollout of Lunit's AI suite—including chest X-ray, mammography, tomosynthesis, and fracture detection—across 79 Starvision sites SEOUL, South Korea, May 7, 2025 /PRNewswire/ -- Lunit (KRX: a leading provider of AI for cancer diagnostics and therapeutics, today announced a strategic partnership with Starvision Service GmbH, Germany's largest private radiology network. Through a newly signed framework agreement, Lunit's AI imaging solutions will be deployed across Starvision's expansive network of radiological practices. Starvision operates 79 locations across seven German federal states, delivering services in radiology, nuclear medicine, and radiation therapy. As a recognized leader in the DACH healthcare market, Starvision is known for its commitment to digital transformation, operational excellence, and high-quality patient care. Under the agreement, Starvision will adopt several of Lunit's AI solutions, including: The first commercial deployments are already underway—including use of Lunit INSIGHT MMG at Radiologische Allianz in Hamburg, supporting the Hamburg breast cancer screening program under the Starvision network. Together with deployments at Die Radiologie, a major regional hospital group operating over 20 medical sites across Bavaria, Lunit's solutions are now supporting approximately 120,000 breast cancer screenings and diagnoses annually across the two institutions. The five-year framework agreement allows additional Starvision locations—and newly affiliated practices—to join at any time, enabling broad scalability across the network. New deployments and clinical trials are already in progress, with individual agreements being signed across Starvision's entities as part of a phased implementation plan. Beyond Starvision, several other healthcare providers across Germany have also expressed interest, reflecting the expanding demand for AI-driven imaging solutions. "Lunit's AI solutions support our radiologists in delivering fast and accurate diagnoses. This strengthens diagnostic confidence and gives us more time to focus on what truly matters: the individual care of our patients," said Uwe Pfeifer, CEO of Starvision Service GmbH. "Partnering with Starvision accelerates our vision of bringing AI-powered precision diagnostics into everyday clinical practice," said Brandon Suh, CEO of Lunit. "Together, we are advancing a new era of radiology where technology enhances the expertise of physicians, delivering better outcomes for millions of patients in Germany and beyond." The partnership supports both companies' vision of transforming healthcare through intelligent technology and setting new standards in radiology. 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

Lunit Announces Partnership with the National Cancer Institute to Advance AI-Powered Biomarker Research
Lunit Announces Partnership with the National Cancer Institute to Advance AI-Powered Biomarker Research

Korea Herald

time31-03-2025

  • Business
  • Korea Herald

Lunit Announces Partnership with the National Cancer Institute to Advance AI-Powered Biomarker Research

Collaboration to apply Lunit's AI technologies across NCI's broad spectrum of cancer studies, aiming to accelerate personalized cancer care SEOUL, South Korea, March 31, 2025 /PRNewswire/ -- Lunit (KRX: a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, today announced a collaboration with the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), to explore innovative applications of AI in cancer research. This collaboration aims to advance research into the tumor microenvironment and immune phenotyping, analyzing NCI data to uncover insights that could drive personalized cancer care. Under the agreement, Lunit tools will be made available to NCI Center for Cancer Research (CCR) investigators, across NCI CCR's portfolio of clinical trials. Lunit will analyze whole-slide images obtained from NCI's clinical studies, using Lunit AI-powered biomarker technologies, including Lunit SCOPE ® IO and Lunit SCOPE universal IHC. This broad collaboration will enable image-analysis AI to become a core part of cancer research practice. The two parties plan to jointly prepare publications, presentations, and reports. The primary objective of this partnership is to develop data-driven insights that can help personalize treatment approaches for cancer patients. By applying Lunit's AI solutions across NCI's extensive cancer research portfolio, the collaboration seeks to accelerate discoveries that optimize immunotherapy strategies, improve patient outcomes, and pave the way for more targeted cancer care. "This collaboration with the NCI is a testament to the power and potential of Lunit's AI-driven solutions in advancing the frontier of cancer research," said Brandon Suh, CEO of Lunit. "By applying our technologies across NCI's unparalleled research expertise and clinical data, we aim to uncover meaningful insights that can transform cancer treatment and deliver more personalized care to patients worldwide. We are honored to work with one of the world's leading cancer research institutions to tackle some of the toughest challenges in oncology." About Lunit Founded in 2013, Lunit (KRX: is a medical AI company on a mission to conquer cancer through AI. Lunit harnesses AI-powered medical image analytics and biomarker analysis to ensure accurate diagnosis and optimal treatment for each cancer patient. The FDA-cleared Lunit INSIGHT suite for cancer screening serves over 4,800 medical institutions across 55+ countries. Lunit clinical studies have been published in top journals, including the Journal of Clinical Oncology and the Lancet Digital Health, and presented at global conferences such as the ASCO and RSNA. Headquartered in Seoul, South Korea, with a network of offices worldwide, Lunit leads the global fight against cancer. Discover more at

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