近日，国家药品监督管理局（NMPA）发布官方信息， 2 款创新医疗器械获批上市 ，分别为 瓦里安医疗系统粒子治疗有限公司 的 质子治疗系统 ，以及 景昱医疗科 技（苏州）股份有限公司 的 植入式脑深部神经刺激系统相关产品。 | 序号 | 产品名称 | 生产企业 | 批准日期 | 所在地 | 注册证号 | | --- | --- | --- | --- | --- | --- | | 385 | 质子治疗系统 | 瓦里安医疗系统粒子 | 2025-12-12 | 德国 | 国械注进 | | | | 治疗有限公司 | | | 20253050582 | | 386 | 植入式脑深部神经刺激电极导线 | 景昱医疗科技(苏州) | 2025-12-15 | 江苏 | 国械注准 | | | | 股份有限公司 | | | 20253122578 | | 387 | 植入式脑深部神经刺激延伸导线 | 景昱医疗科技(苏州) | 2025-12-15 | 江苏 | 国械注准 | | | | 股份有限公司 | | | 20253122579 | | 388 | 植入式脑深部神经刺激器 | 景昱医疗科技(苏州) | 2025-12 ...

该产品由加速器子系统和治疗子系统组成，加速器子系统包括主加速器系统、能量选择系统和射束 传输系统，治疗子系统包括360°旋转束治疗系统和治疗计划系统，适用于治疗全身实体恶性肿瘤及特定 良性疾病。该产品采用悬臂式机架的小型化设计，可节约质子设备的空间、提高治疗效率。 药品监督管理部门将加强上述产品上市后监管，保护患者用械安全。 人民网北京12月16日电 （记者孙红丽）据国家药监局网站消息，近日，国家药品监督管理局批准 了瓦里安医疗系统粒子治疗有限公司的质子治疗系统注册申请。 ...

齐鲁晚报.齐鲁壹点张唯 12月11日下午，在山东省政府新闻办举行的"'十四五'时期山东扎实推进市场监管现代化建设情况"新闻发布会上，围绕山东在"十四五"期间鼓励药械创 新、推动医药产业高质量发展方面，采取的举措与取得的成效等问题，山东省药品监督管理局党组书记、局长李涛作出回应。 李涛介绍，"十四五"期间，山东加大政策支持力度，省政府办公厅出台优化审评审批服务促进医药产业高质量发展若干措施，提出了对1类创新药临床试 验分期最高给予3000万元资金奖补等一系列政策措施。省药监局相继牵头出台促进医药产业高质量发展的"中药30条""医疗器械16条"等133条高含金量配 套措施，有力促进我省创新药械研发能力不断提升。"十四五"以来，全省1类创新药获批10个，为"十三五"时期的10倍；药物新产品获批1018个，年复合 增长率接近40%。 在深化药品监管改革方面，山东坚持以改革的手段破解发展中的难题，着力构建以省级为支点、联通上下、"扁平化"的服务体系。对上，主动融入京津冀 国家战略，积极争取将我省纳入国家药监局药品和医疗器械审评检查京津冀分中心服务范围，不仅让企业享受国家级的专业指导，更能强化区域间标准互 认、监管协同， ...

本次申请的企业主要集中在上海、江苏、广东等省市。申请的产品涉及到11个产品器械分类，主要集中在有源手术器械、无源植入器械，无源手术器械等 类别中。 资料来源：药监局官网、药智医械数据 2025年11月，国家药监局和地方药监局共公示了26款器械进入创新医疗器械特别审查通道。其中国家局发布了10款产品，地方药监局发布了16款产品。 资料来源：药监局官网、药智医械数据 资料来源：药监局官网、药智医械数据 下附26款进入创新通道的器械名单。 2025年11月进入创新器械审批通道的器械 | 创新器械名称 | 申请企业 | 发布日期 | 审核机构 | | --- | --- | --- | --- | | 肾动脉超声消融系统 | 深圳迈微医疗科技有限公司 | 2025/11/28 | 国家药品监督管理局 | | 双极高频超声双输出手术设备 | 上海益超医疗器械有限公司 | 2025/11/28 | 国家药品监督管理局 | | 肾部穿刺手术导航定位系统 | 深圳惟德精准医疗科技有限公司 | 2025/11/11 | 国家药品监督管理局 | | 经导管主动脉瓣 置换手术辅助系统 | 智程医疗科技(嘉兴)有限公司 | 2025 ...

探索"新优药械"从研发到使用的高效对接机制，优化临床急危重症抢救不可替代新药的入院流程，逐步 实现由30个工作日缩减至15个工作日。 为持续鼓励创新药品、医疗器械产品的实际应用，上海的政策支持不断升级。 日前，上海印发《上海市全面深化药品医疗器械监管改革促进医药产业高质量发展的若干措施》（下称 《若干措施》），提出六个方面共22项内容，通过监管制度的改革，来助推药械产业发展。这也是继 2024年7月上海出台《关于支持生物医药产业全链条创新发展的若干意见》（下称《若干意见》）后， 又一次大力度的政策指引。 加快创新产品应用 创新药械产品如何在审批、应用阶段提速是企业重点关切。为此，《若干措施》提出"加快创新产品应 用"，即"持续优化完善我市新上市药品挂网服务，积极申请成为新上市药品首发挂网省份""探索'新优 药械'从研发到使用的高效对接机制，优化临床急危重症抢救不可替代新药的入院流程，逐步实现由30 个工作日缩减至15个工作日""对符合规定的'新优药械'产品，及时研究纳入医保支付范围，鼓励商业健 康险产品覆盖更多'新优药械'"等。 第一财经了解到，与《若干意见》相协同的《上海市生物医药"新优药械"产品目录》今年 ...

Core Insights - The article highlights the approval of three innovative medical devices by NMPA, indicating a growing trend in the domestic medical device industry [1] Company Summaries - Shenzhen Weide Precision Medical Technology Co., Ltd. focuses on the research, production, and commercialization of surgical navigation and robotic systems, founded by a team of returnee PhDs with experience from prestigious institutions [2] - Hunan Huaxiang Medical Technology Co., Ltd. specializes in the application of new biomaterials and 3D printing in medical devices, with a strong emphasis on biodegradable zinc alloy and personalized implant systems [3] - Misen Medical Equipment Co., Ltd. is dedicated to the development of advanced medical devices for tumor treatment, particularly in compact and integrated proton therapy systems, leveraging proprietary technologies [4]

Core Viewpoint - The company provided insights into the operational budget of its proton therapy center, highlighting the complexity and high costs associated with such medical facilities [1] Group 1: Operational Budget Components - The operational costs of the proton therapy system include fixed asset depreciation and amortization, equipment maintenance and operational costs, daily operational expenses, and labor costs [1] - The proton therapy project is characterized by high technical barriers, large investment scale, and long return periods [1] Group 2: Break-even Point and Demand - The break-even point for the proton therapy center is influenced by various dynamic factors [1] - The Xi'an International Medical Center's proton therapy center is the first of its kind in Northwest China and will officially commence operations after obtaining the necessary administrative approvals [1]

Core Viewpoint - The Shanghai Municipal Government has issued the "Action Plan for Promoting the Full-Chain Development of High-End Medical Device Industry," aiming to enhance the high-quality development of the high-end medical device industry in Shanghai and establish a globally influential development hub for this sector [3]. Summary by Categories - **Development Goals**: By 2027, Shanghai aims to approve over 500 new domestic Class III medical device registrations, over 100 medical device products approved in overseas markets, cultivate two leading enterprises with an annual output value exceeding 10 billion, and establish three high-end medical device industrial clusters [3]. - **Key Product Categories**: The action plan identifies eight key product categories for development, including high-end medical imaging and high-end in vitro diagnostic products [4]. - **High-End Medical Imaging Products**: The focus is on accelerating the iteration and upgrade of high-performance products such as positron emission tomography and X-ray computed tomography equipment, as well as developing products like miniaturized home ultrasound devices [5]. - **High-End In Vitro Diagnostic Products**: The plan emphasizes the upgrade of automated medical diagnostic devices and reagents, including new high-throughput sequencers and chemiluminescence diagnostic equipment, and the development of molecular diagnostic devices based on new disease biomarkers [9]. - **High-End Surgical Systems**: The initiative includes accelerating the iteration of high-performance surgical systems, such as laparoscopic surgical robots and developing next-generation flexible surgical robots [8]. - **High-End Radiation Therapy Products**: The focus is on upgrading products like proton therapy systems and developing new products such as flash radiation therapy equipment [11]. - **High-End Rehabilitation Products**: The plan aims to enhance rehabilitation products like rehabilitation robots and exoskeleton robots that can perceive patients' cognitive states in real-time, as well as developing brain-machine interfaces with high-resolution neural signal analysis [13]. - **High-End Artificial Intelligence Medical Devices**: The action plan promotes the upgrade of intelligent medical imaging diagnostic software and surgical navigation systems, along with the development of medical intelligent entities and embodied intelligent robots [15]. - **Future Innovative Devices**: The plan encourages the development of future treatment products such as precision therapy micro-nano robots and products based on quantum and nucleic acid mass spectrometry technologies [16]. - **Key Tasks**: The action plan outlines 20 key tasks, including strengthening basic research, advancing key materials and core production processes, and accelerating the development and application of artificial intelligence technology, ensuring effective implementation to support the high-quality development of Shanghai's high-end medical device industry [17].

Group 1 - The core point of the article highlights the successful launch of the dual-target weight loss drug, Masitide, which is the first and only approved drug of its kind globally, significantly impacting the international weight loss drug market [1] - The rapid approval and market entry of Masitide are attributed to Jiangsu's robust regulatory framework that facilitates innovation and production efficiency [1] - The biopharmaceutical industry faces challenges in innovation, particularly regarding the gap between traditional drug approval standards and the actual needs of companies [1] Group 2 - Jiangsu Province has implemented a "one enterprise, one policy" support mechanism to address the needs of innovative drug and device companies, facilitating early intervention in the review process [2] - A comprehensive reform initiative covering the entire chain from research and development to manufacturing and distribution is underway in Jiangsu [2] Group 3 - The approval of the proton therapy system by Maysun Medical Systems represents a significant advancement in cancer treatment, offering more precise radiation therapy compared to traditional photon therapy [3] - The complexity of large-scale medical devices requires on-site assembly and testing, leading to challenges in regulatory compliance and quality assurance [3] Group 4 - Jiangsu's "Innovative Drug and Device Consultation Service Interaction Platform" has engaged 93 companies, covering 208 innovative drugs and over 250 medical devices, streamlining the registration and inspection process [4] - The platform supports the transition of innovative drugs and devices from laboratory development to market availability, enhancing the competitiveness of Jiangsu's biopharmaceutical industry [4]

Core Insights - The article highlights the rapid approval and market entry of the dual-target weight loss drug, Masitide, which is the first of its kind globally, marking a significant milestone in the biopharmaceutical industry [1][4] - The article emphasizes the innovative regulatory reforms in Jiangsu province that facilitate the development and approval of new drugs and medical devices, showcasing a proactive approach to meet industry needs [2][6] Group 1: Masitide and Its Market Impact - Masitide was approved for market entry in just 16 months after the application submission, indicating a significant acceleration in the drug approval process [1] - The drug's unique dual-target design positions it as a disruptive force in the international weight loss medication market, contributing to substantial revenue growth for the company [1][4] Group 2: Regulatory Reforms and Support Mechanisms - Jiangsu province has established a "one enterprise, one policy" support mechanism to address the specific needs of innovative drug and device companies, enhancing the approval process [2][6] - The province's drug regulatory authority has implemented a comprehensive evaluation system for major innovative products, including on-site assessments and personalized solutions to ensure compliance and safety [2][3] Group 3: Broader Industry Innovations - The article mentions the approval of the proton therapy system by Maysun Medical Systems, which represents a significant advancement in cancer treatment technology, offering more precise radiation therapy compared to traditional methods [3] - Jiangsu's "innovative drug and device consulting service interaction platform" has attracted 93 companies, facilitating the registration and inspection processes for over 208 innovative drugs and 250 medical devices [4][5] Group 4: Systematic Reforms and Future Directions - The article outlines a systematic reform approach in Jiangsu aimed at enhancing the entire biopharmaceutical industry chain, from research and development to manufacturing and distribution [6][7] - The province's commitment to optimizing drug regulatory processes and fostering innovation is expected to strengthen its position as a global hub for biopharmaceutical research and manufacturing [6][7]