Elutia 表示，本次交易强调了其独创药物释放生物学平台的价值，同时确保公司可在无需稀释股权的前提下完 成近期管线产品的开发与商业化，包括 下一代抗菌生物基质 NXT-41x ，专注于乳房重建市场，预计交易将 于 2025 年第四季度完成。 # 技术亮点与临床数据聚焦：EluPro 与 CanGaroo EluPro —— 药物释放型生物信封，集抗菌与组织再生于一体 上海活动报名： 2025医疗器械研发创新论坛 2025年9月9日，医疗技术公司 Elutia （纳斯达克代码：ELUT）宣布达成一项含现金的交易，将其 药物释放 型生物信封技术 EluPro 与 CanGaroo 出让给 Boston Scientific ，总交易金额为 8800 万美元 （约合人民 币6.3亿） 。 EluPro 和 CanGaroo 均为用于保护接受植入式医用器械患者的创新性解决方案，其中 EluPro 已获美国 FDA 于 2024 年 6 月清除（适用于心脏起搏器、除颤器等设备，扩展至神经调节器、神经刺激器等领域）。 材料与构造 ： EluPro 由天然细胞外基质（ECM）构成，融合抗菌药利福平（rifampin）和米 ...

上海活动报名： 2025医疗器械研发创新论坛 2025年9月9日， 美敦力 （Medtronic，NYSE: MDT）今日宣布，将其 最新一代 Evolut FX+ 经导管主动 脉瓣置换术（TAVI）系统正式引入印度市场 。该产品已于今年 6 月获得印度中央药品标准控制组织 （CDSCO）批准，此举标志着其结构性心脏病治疗布局进入印度阶段。此前 Evolut FX+ 已取得 美国 FDA 批准与欧洲 CE 认证 ，具备全球通行证资质。 # 技术亮点：满足当前 STENT 标准，同时兼顾未来介入需求 # 临床依据：真实世界与随机对照研究支持 Evolut 平台优势 SMART 2 年数据：在小瓣环患者中显示出更优性能 SMART Trial 是 首个 全球大型、随机对照、针对小主动脉瓣环患者的 Evolut 与 SAPIEN 头对头研究。数 据显示，在两年随访中，Evolut TAVR 在生物瓣功能障碍（BVD）发生率上明显优于 SAPIEN，同时复合 终点（死亡率、中风或再住院）无显著差异： 针对低外科风险患者的随机研究（Low-Risk Trial），显示 Evolut TAVR 在五年随访中： 此外，Ev ...

上海活动报名： 2025医疗器械研发创新论坛 生命科学与医疗科技领域正加速将人工智能融入研发和临床应用。然而，对于企业而言，最大的挑战之一是如何在创新速度和严格合规之间找到平衡。FDA和欧盟 MDR等监管框架要求企业提交大量验证、追溯和合规性文件，传统合规工具往往未能适应人工智能快速迭代的节奏。 Ketryx的核心平台通过AI和自动化技术，为产品开发提供完整的合规解决方案。 它能够自动生成并维护FDA/EU MDR所需的验证与追溯文件，覆盖整个产品生命周 期。 客户反馈显示，该平台能够将文档工作量减少高达90%，并将发布周期缩短超过10倍。 这种效率提升不仅节省了时间和成本，更重要的是降低了因合规延迟而错失市场窗口的风险。随着AI在诊断、影像分析和药物开发中的应用快速扩展，零延迟的合 规体系对于医疗器械企业而言已不再是"锦上添花"，而是"必需品"。 在这一背景下，Ketryx将自己定位为 AI原生合规基础设施 ， 旨在通过自动化验证和实时追溯体系，帮助团队在保持合规的同时加快产品上市。 正如Ketryx CEO兼 创始人Erez Kaminski所言："合规不能再是阻力，而应成为创新的助推器。" 2025年9 ...

上海活动报名： 2025医疗器械研发创新论坛 2025年9月8日，捷迈邦美Zimmer Biomet宣布已向纽约州最高法院提起诉讼，要求德勤公司赔偿 1.72亿美元 ，原因是德勤在为Zimmer Biomet实施的企业资源 规划（ERP）系统中存在严重失误，导致该项目成本大幅超支并对公司的业务运营造成重大影响。Zimmer Biomet表示，德勤的实施方法不当，使得公司无法正常 运作，甚至影响到公司医疗器械的供应和患者治疗。 # 问题的根源：德勤的ERP实施"灾难" 根据Zimmer Biomet的诉讼，德勤公司在推销其SAP S/4HANA ERP系统时，承诺这套系统将为Zimmer Biomet节省1.97亿到3.16亿美元的成本。 然而，实际情况却远远低于预期，反而导致了公司巨大的损失。Zimmer Biomet指控 德勤在实施过程中提供了错误的技术方案，并承诺的技术能力未能兑现，使得 项目费用超支36%。产生了51个变更订单，导致 额外费用2300万美元 。 系统本应替换Zimmer Biomet的遗留系统，提升北美和拉丁美洲的运营效率，但实际却仅在北美地区上线，并且存在严重缺陷。项目不仅推迟了数月， ...

当传统CT扫描仍困于"卧位"的物理局限时，中国医疗影像行业已悄然完成一场颠覆性突破。9月8日，国家药品监督管理局（NMPA）正式批准赛诺威盛自主研发的 全球首台1米超大孔径站立位全身螺旋CT —— OmegaCT One 上市（国械注准：20253061803），填补了全球站立位全身CT的技术空白，标志着中国高端医疗装 备从"跟跑"迈向"领跑"的跨越式发展。 # 颠覆性创新：从"卧位"到"站立位"，破解临床百年难题 传统CT扫描依赖患者平躺，但重力会导致内脏器官移位、骨骼肌肉受力改变，造成临床诊断与影像学结果的"错位"——例如，腰椎间盘突出在站立时椎间盘受压增 加，突出更明显，而躺下后常因体位放松"掩盖" 病变，容易让医生误判病情。这一矛盾 长期困扰骨科、肿瘤科、呼吸科等科室，甚至导致治疗方案和手术规划偏差 。赛诺威盛OmegaCT One以业界首创的站立位扫描模式，彻底打破这一临床痛点，显著提升了疾病的诊断准确率，最终实现精准诊疗。 # 突破性设计彻底改写诊疗范式 # 临床价值直击痛点 OmegaCT One以 "还原真实生理状态" 为核心，能够揭示在传统仰卧位CT扫描中无法发现的、由重力（自重）和负荷所导 ...

Core Viewpoint - The second Medical Device R&D Innovation Forum will be held during Medtec China 2025 in Shanghai, focusing on the technological evolution and transformation challenges of interventional medical devices in the areas of intelligence, precision, and personalization [2]. Group 1: Event Details - The forum is organized by Siyu MedTech and Informa Markets' Medtec China team, inviting founders and executives from various companies to discuss product innovation pathways and implementation mechanisms [2]. - Confirmed participants include executives from companies such as Suzhou InnoCare, JuZheng Medical, HaiSheng Medical, and others, along with several university professors and clinical experts [2]. Group 2: Agenda Overview - The event will take place on September 25, 2025, at the Shanghai World Expo Exhibition and Convention Center, with an expected attendance of 120 people [5]. - The agenda includes sessions on intelligent technology empowering interventional medical device R&D, clinical transformation and application of interventional medical devices, and a roundtable discussion on future opportunities and challenges [4][5][6]. Group 3: Thematic Sessions - The morning session will cover topics such as the application of intelligent devices in interventional surgery, advancements in navigation technology, and the use of flexible robotic arms in treatment [5]. - The afternoon session will focus on the entire innovation process of interventional medical devices, including AI-assisted surgical planning and remote monitoring and data analysis post-surgery [9].

Core Viewpoint - Senseonics is reclaiming global commercialization rights for the Eversense continuous glucose monitoring (CGM) platform from Ascensia Diabetes Care, aiming for more efficient promotion of the Eversense 365 product [2][5]. Financial Aspects - Without revenue sharing with Ascensia, the company's revenue could have been 20% higher and gross margin could have been 45% higher in the last quarter [4]. - The company has secured up to $100 million in financing from Hercules Capital to support its commercial infrastructure [4]. - The projected net sales for 2025 are estimated to be between $34 million and $38 million, with a gross margin maintained between 32.5% and 37.5% [4]. Team Transition - Brian Hansen, head of Ascensia's CGM business, and his team will join Senseonics to continue the commercial advancement of Eversense [4]. Payment and Coverage - Eversense has gained extensive commercial insurance and Medicare coverage, with ongoing expansion of physician prescriptions and implantation networks [4]. Technological Features and Clinical Data - Eversense 365 is the world's first one-year implantable iCGM, with 90% of sensors used for 365 days in a clinical study, and 92% of data points within ±20% error in the blood glucose range of 40-400 mg/dL [6]. - Starting February 2024, Medicare will expand CGM reimbursement to all insulin users and some high-risk hypoglycemia patients, facilitating Eversense 365's commercialization [6]. Business Model Transition - Senseonics is shifting from a partnership model to self-operation to better control sales channels and leverage its differentiated product advantages [11][13]. - The choice of business model is crucial for achieving scalable growth in the CGM market, which involves implant procedures and long-term follow-ups [10]. Market Challenges - The transition to self-operation presents both opportunities for profit release and risks of execution failure, with the need for effective team performance across the entire value chain [18]. - The CGM market remains dominated by competitors like Dexcom and Abbott, posing challenges for Senseonics to carve out its niche [18].

Core Viewpoint - Edwards Lifesciences has completed the acquisition of Vectorious Medical Technologies for approximately $497 million, marking a strategic shift towards remote monitoring of heart failure patients, indicating a trend in cardiovascular treatment moving from "device implantation" to "device + data management" [2][4]. Acquisition Details - The acquisition values Vectorious at $497 million, with Edwards previously acquiring 52% of the company in 2023 before completing the purchase of the remaining 48% in September 2025 [4]. - Vectorious will continue to operate as a wholly-owned subsidiary based in Tel Aviv [4]. Core Technology: V-LAP Sensor - The V-LAP sensor is implanted via minimally invasive surgery and monitors left atrial pressure in real-time, aiding in the management of heart failure [5]. - The sensor's data is uploaded daily to a dedicated mobile application, allowing doctors to track patients remotely [5]. Clinical Progress - The acquisition signifies that Edwards is completing a full chain of management from valve replacement to heart failure management [7]. Company Background and Strategic Extension - Vectorious is a pioneer in remote monitoring for heart failure, aiming to reduce hospital readmissions and improve patient quality of life [9]. - The V-LAP sensor is the first of its kind globally, enabling proactive management of heart failure through daily monitoring [9]. Strategic Logic: Phased Acquisition Path - Edwards has a history of strategic acquisitions, including Innovalve and a partnership with Affluent Medical, enhancing its position in the heart valve market [13]. - The acquisition of Vectorious represents a significant step into remote monitoring and digital health, transitioning from "device treatment" to "comprehensive disease management" [13]. - The phased approach of investing, acquiring control, and then fully integrating allows for reduced innovation risk while ensuring a foothold in new markets [13]. Industry Implications - The acquisition reflects a broader trend in cardiovascular care, moving from structural repair to active monitoring and comprehensive management [15]. - The V-LAP sensor exemplifies the integration of devices and data platforms for remote management and digital health [14]. Insights for the Chinese Market - The growing number of heart failure patients in China, combined with supportive healthcare policies, presents opportunities for local companies to explore the integration of "device + digital" solutions [16].

上海活动报名： 2025医疗器械研发创新论坛 近日，全球"冷阴极"分布式X射线源引领者 新鸿电子有限公司 （简称：新鸿电子）宣布完成 数亿元战略融资 。 本轮融资由中核基金领投，中国视谷基金、荷塘创投、常州金坛区产业母基金跟投。募得资金将用于 扩大创新型"冷阴极"X射线源产能，推进医学影像、工业无损 检测、安检等领域解决方案的研发与商业化 。 图：新鸿电子"冷阴极"分布式X射线源（部分产品） 本轮获得央企产业基金和政府引导基金的联合投资后，公司将持续整合在前沿科技领域已构建的生态资源，加速推进高端成像核心部件及整机系统的技术研发与产 业化进程，致力于提升在高端辐射成像装备领域的自主创新能力和全球市场竞争力。 # "冷阴极"分布式X射线源 的技术进展 近年来，移动CT、快速CT等创新设备的迅速发展，对X射线源提出更高要求——尽可能在更小体积内实现高功率，以满足快速扫描、高清成像等应用需求，这极大 地推动了一系列技术难题的加速解决。 "冷阴极"X射线源通过碳纳米管场效应发射电子产生X射线，无需依赖传统热阴极的高温加热过程，具备响应速度快、功耗低、易于集成等显著优势。这些特性吸引 多家跨国影像设备巨头积极布局该技术 ...

Core Viewpoint - The article announces the Third China Plastic Surgery Innovation and Transformation Competition, inviting innovative medical beauty projects from the central region to participate, aiming to discover and cultivate potential innovative enterprises and research teams in the medical beauty industry [1][2]. Group 1: Competition Details - The competition is themed "Technology Leads Plastic Surgery, Innovation Drives the Future" and is organized by Beijing Ba Da Chu Plastic Surgery Medical Technology Group and Zhongguancun Medical Device Park [2]. - The central competition area includes Beijing, Tianjin, Hebei, Henan, Shanxi, and other unregistered projects from different regions, with a registration deadline of September 20, 2025 [3][2]. - The competition will provide opportunities for participants to engage with top industry experts and receive various support, including financial incentives, research resources, and market access [9]. Group 2: Evaluation and Awards - The evaluation committee consists of clinical experts (60%) and transformation experts (40%), with a total of 10-15 judges [14]. - The awards include a first prize of 50,000 yuan, second prize of 20,000 yuan, and third prize of 10,000 yuan, along with service packages for concept validation and animal testing [13]. - The evaluation criteria focus on innovation, technical feasibility, market potential, team capability, and transformation potential, with varying weightings assigned to each dimension [14]. Group 3: Participation Criteria - Eligible participants include medical institutions, universities, research institutions, and teams planning to establish innovative enterprises in the medical beauty field [9][10]. - Projects must be related to plastic surgery, medical beauty, biomedicine, medical devices, diagnostic reagents, or medical services, with clear intellectual property rights and significant innovation [10]. Group 4: Support Services - The Ba Da Chu Plastic Surgery Medical Concept Validation Center offers a comprehensive service platform for technology transfer, providing support from concept incubation to product launch, including technical support, compliance, and intellectual property management [15].