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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:328130.KQ), 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. The next-generation Lunit INSIGHT CXR4 interface showing AI-powered analysis of a chest X-ray. The solution supports detection of 12 chest abnormalities, including lung nodules, pneumonia, and acute bone fractures. (Image courtesy of Lunit) 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: Normal Flagging: While other solutions may flag cases as normal simply due to the absence of detectable findings, CXR4 takes a more advanced approach—leveraging an AI engine trained on over 1,200,000 chest X-rays to proactively identify and confirm truly normal cases. Backed by a high negative predictive value (NPV) of 99.5%, CXR4 can reliably distinguish low-risk exams. For these high-confidence normal cases, the system automatically generates structured reports, helping radiologists reduce reading time and streamline workflow without compromising diagnostic safety. Current-Prior Comparison: Compares a patient's current chest X-ray with previous images to detect disease progression or improvement over time—enabling more informed clinical decisions. The latest version also supports nodule comparisons, offering added value for lung cancer screening and follow-up evaluations. New Finding—Acute Bone Fracture Detection: Enables detection of recent traumatic fractures within the chest X-ray field of view. By identifying subtle fractures that are easy to miss, CXR4 helps reduce interpretation time and improve diagnostic accuracy, particularly in busy clinical environments. 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:328130.KQ) 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.io.
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.
PARIS, April 7, 2025 /PRNewswire/ -- DOSIsoft, leading provider of patient-specific imaging and dosimetry software solutions for radiation oncology and nuclear medicine, proudly announces the latest release of PLANET® Onco Dose version 3.2 – multi-radionuclide, personalized, voxel-based dosimetry platform for SIRT and MRT – now approved for market in EU under CE MDR Mark and in the US with FDA 510(k) clearance. End-to-end, versatile, vendor-neutral, the novel PLANET® release is specially designed to integrate multi-radionuclide, implement multi-workflow and support multi-therapy. This advanced software version allows clinics to cover a broader range of therapies by supporting voxel-based dose computation for 90Y, ¹⁷⁷Lu ¹⁶⁶Ho and ¹³¹I isotopes with the flexibility to incorporate new beta/gamma emitters. Clinicians can benefit from optimized multi-time point and newly introduced single-time point dosimetry workflows – reducing workload, enhancing patient comfort, streamlining clinical processes while ensuring accuracy. Validated against thorough Monte-Carlo simulations, it offers clinical-ready GPU-accelerated performances. "All-in-one dosimetry solution for Patient specific Theranostics," PLANET® enables highly personalized treatments including 177Lu-PSMA, 177Lu-PRRT, 90Y or 166Ho radioembolization, ¹³¹I therapies, and more. PLANET® Onco Dose is CE Marked under new EU MDR Regulation 2017/745 since February 17th, 2025. Learn more. PLANET® Onco Dose is US FDA 510(k) cleared since March 14th, 2025, expanding previous market clearance to version 3.2 rich feature set. As per FDA general rule for Radiopharmaceutical Therapy (RPT), voxel-based dosimetry solutions are intended specifically for absorbed dose calculation and should only be used with approved radioactive products. Learn more. "It is a milestone achievement and a collective work to provide all answers to the EU notified body and US FDA, Through our reinforced internal Quality System and commitment to the highest standards of safety, performance and compliance, DOSIsoft positions PLANET® Onco Dose, ahead of completion," highlights Marc Uszynski, CEO at DOSIsoft. "We are looking forward to seeing patients worldwide benefit from this safe and effective device in routine clinical use." About DOSIsoft Founded in 2002, DOSIsoft stands as market leader specialized in dosimetry software in Radiation Oncology and Nuclear Medicine to improve cancer patient safety and treatment quality. DOSIsoft provides the most competitive patient-specific quality assurance and medical imaging solutions in over 600 hospital centers in 60 countries. Spin-off between Gustave Roussy and Curie Institute in France, DOSIsoft constantly innovates in partnership with leading cancer institutes and research centers in the world, like recently through the Thera4Care European project. www.dosisoft.com. Contact:Mme Xiaolu ChenService Marketingxiaolu.chen@dosisoft.com
Sophos 委託進行的一項獨立研究，評估了各種網路安全防禦措施對網路保險理賠金額的財務影響，以及資安產品與服務的投資報酬率 (ROI)。研究結果顯示，在美國，使用託管式偵測與回應 (MDR) 服務的企業，其網路保險理賠金額比僅依賴端點防護的企業低 97.5%。 研究重點發現： MDR 服務顯著降低了理賠金額：使用 MDR 服務的企業，其理賠金額比僅依賴端點防護的企業少 97.5% ( 7.5 萬美元 vs. 300 萬美元)。 EDR/XDR 解決方案亦可減少理賠金額：使用 EDR/XDR 的企業，其理賠金額僅為單純使用端點防護企業的六分之一 (50 萬美元 vs. 300 萬美元)。 使用 MDR 服務的企業理賠金額最具可預測性，而使用 EDR/XDR 工具的企業理賠金額則波動較大。 MDR 服務可加速網路攻擊事件後的復原：近一半 (47%) 使用 MDR 服務的企業可在一週內完全復原，而僅依賴端點防護的企業僅有 18% 能在一週內復原，使用 EDR/XDR 解決方案的企業則為 27%。 MDR 服務的勒索軟體事件復原時間最為可預測，而使用 EDR/XDR 工具的企業復原時間變異較大。 隨著網路威脅不斷增加、保險費用持續上升，這份研究量化了資安投資的實際財務影響，為企業與保險公司提供有數據支援的見解，以最佳化網路防禦策略。研究結果顯示，MDR 服務是降低理賠成本、減輕風險並加速復原的最有效方法。 為何這項研究至關重要 企業每年在網路安全上的投資金額龐大。本研究透過量化各種網路安全控制措施對網路攻擊結果的影響，幫助企業將資安投資導向能帶來最大回報的領域。 同時，保險公司在網路安全支出方面具有重要影響力，可透過要求企業具備特定的安全管制措施作為保單承保條件，或針對特定防禦措施提供保費折扣。本研究能幫助保險公司確保他們鼓勵企業投資的項目確實能對事件結果與理賠金額產生正面影響。 研究標準 本研究分析了 232 家企業的 282 起理賠事件，這些企業的員工數介於 50 至 3,000 人。受訪企業採用了來自多家供應商的資安解決方案，包括 19 家不同的端點防護廠商 和 14 家 MDR 服務提供商。此外，所有企業在發生導致理賠的網路攻擊時，均已部署多重身分驗證 (MFA)。 本研究由 Vanson Bourne 受 Sophos 委託進行。
Sophos 是以創新安全解決方案對抗網路攻擊的全球領導者，今日宣布其 Sophos Managed Detection and Response (MDR) 服務已達成重要里程碑，目前全球保護超過 26,000 家組織，且 2024 年客戶數量成長高達 37%。這項成就突顯了市場對 Sophos 主動且由專家引領的安全解決方案需求日益成長，該解決方案能協助所有規模的組織全天候防禦日益複雜的網路威脅，包括最先進的勒索軟體攻擊、商業電子郵件詐騙 (BEC) 和網路釣魚攻擊。 Sophos MDR 提供一套全面的功能，不僅具有標準的威脅遏制，還涵蓋全方位的事件回應服務，包括根本原因分析、移除攻擊者使用的惡意工具或檔案，以及在客戶環境中進行深入調查，以確保完全驅逐攻擊者並防止再次攻擊。Sophos 的另一個顯著優點在於，這些事件回應服務皆包含於 Sophos MDR 中且無使用次數限制，客戶無需支付額外費用，事件回應工時也沒有上限。此外，Sophos MDR Complete 還提供一項高達 100 萬美元的資料外洩保障，可用於涵蓋事件回應相關費用。此外，Sophos 還為客戶提供與 MDR 分析師合作的彈性選項，包括允許客戶預先授權分析師遏阻作用中的威脅。 Sophos 對 MDR 的投資與全新功能 Sophos 在其 MDR 服務上進行了大量投資，包括強化分析師陣容、引入 AI 輔助工作流程、新增功能以及擴展整合等，以便透過改進的威脅防護、偵測和調查，提供最佳的安全效果。Sophos 新增了以下全新功能： 價值證明：全新的 Sophos MDR 服務見解，說明 MDR 團隊的行動，包括摘要出投入於威脅捕獵及建立與調整偵測功能的人力時數。非常有價值的儀表板強化功能，包括 Sophos MDR 團隊主動威脅捕獵中揭露的 MITRE ATT&CK 策略細節、MDR 分析師監控的範圍、案例調查摘要，以及一個帳戶健康檢查狀態。 針對 Microsoft 客戶的強化安全性：全新 Sophos 專屬偵測功能適用於 Microsoft Office 365，能識別包括商業電子郵件詐騙和中間人帳戶接管攻擊等威脅，且不受限於客戶的 Microsoft 授權等級。 擴展與第三方的相容性：擴大的即時整合生態系統，涵蓋與第三方網路安全和 IT 工具的整合，且新增「備份與復原」整合類別。 主動漏洞緩解：Sophos Managed Risk 搭載 Tenable 技術，為 Sophos MDR 客戶提供全新的託管式服務選項，進行受攻擊面漏洞管理。 效率與自動化：Sophos MDR 新增了以 AI 驅動的工作流程，簡化營運流程並提升安全效果。此創新透過更高效的優先排序降低了平均回應時間 (MTTR)，同時確保能快速調查所有真正的威脅。這讓分析師能專注於其他任務，例如威脅捕獵、帳戶健康監控以及偵測工程。 Sophos 產品管理資深副總裁 Rob Harrison 表示：「攻擊者不斷改進攻擊策略，以避開傳統的安全防禦機制，我們的客戶依賴 Sophos MDR 來全天候協助它們應對當前的威脅，以及提供全方位的事件回應服務。Sophos MDR 不僅能移除作用中的攻擊者，還能進行根本原因分析，找出導致事件發生的潛在問題。我們持續透過全新的功能與整合來進化解決方案，就如攻擊者不斷改進其策略一樣，以確保客戶能在威脅升級為破壞性攻擊之前成功阻止它們。」 更佳的整合：Sophos MDR 的整合功能 Sophos 大幅投資第三方整合功能，讓 MDR 客戶能從更廣泛的工具和產品中接收並分析事件與警示，同時擴展針對 Microsoft 環境中可疑行為所識別的專屬偵測功能。這些整合包括： 全新備份與復原整合套件，包含與 Acronis、Rubrik 和 Veeam 的整合，以強化對勒索軟體的防禦能力。 Microsoft Office 365 管理活動整合，支援在 Microsoft 生態系統中接收稽核日誌與安全警示。目前已有超過 9,000 位客戶在 Sophos MDR 解決方案中使用此整合功能。 Sophos MDR 榮譽 Sophos MDR 在 2024 年獲得了來自客戶、分析師及媒體的多項認可與殊榮： Sophos 在《IDC MarketScape: 2024 年全球託管式偵測和回應 (MDR) 廠商評估》中被評為領導者 Sophos 在 《IDC MarketScape: 2024 年歐洲託管式偵測和回應 (MDR) 服務廠商評估》中被評為領導者 Sophos 在 Frost & Sullivan 的《2024 年全球託管式偵測和回應 (MDR) Frost Radar™》中被評為領導者 Sophos MDR 獲得 2024 年 SC Awards《最佳託管式偵測和回應服務獎》，以及 2024 年 SC Awards《歐洲最佳託管式安全服務獎》 Sophos 連續第二年被 Gartner® Peer Insights™ 評為 MDR 服務的「客戶首選」 Sophos MDR 獲選為 CRN《2024 年年度產品》中「營收與利潤類別」的得主 Sophos MDR 對當前威脅的分析 在過去 12 個月內，Sophos 分析了以下 MDR 案例並與客戶分享了調查結果： 2024 年 12 月，Sophos 發布了《內部威脅：Sophos 主動攻擊者報告》，深入剖析了攻擊者在 2024 年上半年使用的行為變化與攻擊技術。該數據來自近 200 起事件回應 (IR) 和 MDR 案例，顯示攻擊者正尋找利用受信任應用程式或「藉助現有二進位檔案」(LOLbins) 隱身的方法。Sophos 發現濫用這些應用程式的情況增加了 51%。 Sophos X-Ops 公布資訊，指出 Akira 勒索軟體案例在其 MDR 和事件回應 (IR) 客戶中呈現上升趨勢。自 2024 年 11 月以來，Sophos 已處理了 8 起相關案例，這些案例來自 Akira 在過去六個月內披露的 127 位受害者。 2024 年 6 月，Sophos MDR 公布了一項持續近兩年的網路間諜活動的詳細資料，該活動針對東南亞某高層政府機構。Sophos 將此行動命名為「紅宮行動 (Crimson Palace)」，其中涉及三個相互交疊的威脅活動集團，而這些活動與幾個知名的中國國家級攻擊團體有關。 來自 Sophos MDR 客戶的回饋 Sophos 在第二份 Gartner® Peer Insights™《客戶之聲》MDR 報告中被評為「客戶首選」廠商。截至 2024 年 9 月 30 日，Sophos 在 344 則評價中獲得了 4.9/5 的最高整體客戶評分。這些經過驗證的客戶評價一致讚揚 Sophos MDR 的創新表現。 以下是客戶對 Sophos MDR 的評價： 「過去我們很難管理工具和技術產生的警示和事件，但部署 MDR 後，我們完全放心了。此外，我們還使用了其他 Sophos 產品，從可管理性的角度來看，我們的整體體驗也非常好。」——來自醫療與生物科技行業的 IT 副主任 「Sophos MDR 是 Sophos 提供的極佳產品與服務，有了 MDR 後，您不再需要 SOC。」——來自 IT 服務行業的 IT 經理 「Sophos MDR 是市場上最好的服務之一。有了這項服務，威脅捕獵的負擔減輕了，讓我們晚上能安心入睡。」——來自零售行業的 IT 基礎架構專家 「我們使用 Sophos MDR 的體驗非常正面。我們能更安心了，因為 Sophos 團隊作為我們團隊的延伸，可全天候進行威脅捕獵、偵測和修復。」——來自營運專員
Commercial validation in Europe parallels ongoing RESPONDER-HF clinical trial TEWKSBURY, Mass., Dec. 21, 2024 /PRNewswire/ -- Corvia Medical, Inc., a company dedicated to transforming the treatment of heart failure, announced today that it has achieved CE certification for the Corvia® Atrial Shunt System under the latest EU Medical Device Regulations (EU MDR 2017/745). The Corvia Atrial Shunt is a catheter-based cardiac implant designed to reduce heart failure symptoms by lowering pressures in the heart and lungs. Heart failure (HF) affects over 26 million people worldwide, with more than half experiencing heart failure with preserved ejection fraction (HFpEF), a condition in which patients are comfortable at rest but become immediately breathless with any exertion. Treatment options are limited. The Corvia Atrial Shunt is designed to alleviate elevated left atrial pressure (LAP) — a primary driver of HF symptoms — by creating a controlled passage between the left and right atria. Some 70 study sites worldwide are currently participating in RESPONDER-HF, a confirmatory, randomized clinical trial enrolling HF patients without latent pulmonary vascular disease or pacemakers, who have been shown in previous Corvia trials to experience substantial clinical benefit from shunting. "The CE Mark under the MDR for an implantable therapeutic cardiac device with the strictest requirements is a significant milestone for Corvia Medical" said Kate Stohlman, VP of Quality and Regulatory Affairs at Corvia Medical. "This approval reflects the dedication, commitment and efforts of our entire global team to the highest levels of device safety and clinical performance, and to continuously meet the requirements of the regulatory authorities." About Corvia Medical, Inc. Corvia Medical, Inc. is revolutionizing the treatment of heart failure through novel transcatheter cardiovascular devices. Founded in 2009 and headquartered in Tewksbury, MA, Corvia is dedicated to transforming the standard of care for heart failure treatment, enabling patients to reclaim their lives. The Corvia Atrial Shunt was granted Breakthrough Device designation by the FDA in 2019. Privately held, the company is backed by Third Rock Ventures, General Catalyst Partners, AccelMed, Lumira Ventures, Edwards Lifesciences, and an undisclosed strategic investor. For more information visit visit us.corviamedical.com. Physician referral/enrollment information for the RESPONDER-HF trial can be found at https://us.corviamedical.com/healthcare-professionals/reduce-lap-hf-clinical-program/responder-hf/ MEDIA CONTACT:Lisa Ensz+1 978-654-6120lensz@corviamedical.com
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