Core Insights - In 2025, there is a noticeable trend of capital concentration in the Chinese medical device industry, with funds being directed towards fewer and more certain directions [2] - The analysis of 92 billion-level financing events reveals that capital is increasingly focused on high-end diagnostic and imaging equipment, surgical robots, and core components [8][10][12] Financing Overview - The top financing events include companies like United Imaging (10 billion), Fourier (8 billion), and Core Medical (7.2 billion), indicating a strong interest in advanced medical technologies [3] - The financing amounts show a clear gradient structure, with a few head companies receiving large sums while many others receive smaller amounts, reflecting a layered investment strategy [25] Sector Analysis - High-end diagnostic and imaging-related companies dominate the financing landscape, accounting for the highest proportion of investments [8] - Surgical robots and automation projects are also significant, making up nearly 20% of the sample, with a focus on projects that have clear execution roles [10][11] - Cardiovascular and interventional projects are highly concentrated, with fewer projects but larger financing amounts, indicating a preference for high-value investments in this area [12] Industry Positioning - There is an increasing emphasis on upstream core components and foundational capabilities, with these projects representing about 10-15% of the sample [17] - Platform-based capabilities are becoming more prominent, with over 15% of the sample consisting of companies that offer services or solutions rather than single products [19] Investment Logic - The financing choices reflect a systematic selection logic, where projects are evaluated based on their potential to be integrated into existing healthcare systems rather than merely their popularity [24] - The capital is not solely focused on "hot tracks" but is instead making decisions based on the long-term viability and clinical value of the technologies [27][28]

2025 年，思宇MedTech围绕医疗科技多个核心赛道，持续发布系列行业白皮书， 系统呈现全球医疗器械与 技术创新的发展图景。希望通过专业、结构化的方式，让真正推动产业进步的创新力量，被更多人看见、理解 与尊重。 白皮书下载链接已附文末，欢迎保存与转发~ # 2025 年思宇白皮书体系回顾 2025 年，思宇围绕医疗科技多个关键创新方向，陆续发布并更新了多本行业白皮书，逐步形成具有体系性的 年度内容骨架。 一、从产业能力出发：医疗器械 BD 白皮书 《2025 医疗器械 BD 白皮书》以医疗器械行业特有的商务拓展逻辑为切入点，系统梳理了不同发展阶段企业 在并购、引进、合作与授权中的实际需求与能力结构。这一主题并非通用管理话题，而是高度贴合医疗器械产 业特性的现实议题，也回应了大量企业在发展过程中的真实困惑。 二、在成熟赛道中寻找长期价值：超声刀白皮书 《2025 超声刀白皮书》聚焦一个已相对成熟、但仍持续孕育优秀企业与技术演进空间的赛道。白皮书从技术 路径、产品代际、临床应用与市场结构等多个维度，系统呈现超声刀产业的真实图景，强调成熟赛道同样值得 被认真研究与长期关注。 三、聚焦高创新密度赛道：眼科、手术机 ...

2026年1月16日，国家药品监督管理局公布了 创新医疗器械特别审查申请审查结果公示（2026年第2号） ， 有 4款产品 进入创新通道 。 1 . 产品名称 ： 骨 盆 骨 折 手 术计划软件 申请人：北京罗森博特科技有限公司 北京罗森博特科技有限公司成立于2017年，是一家专注于骨科手术机器人与术中智能规划系统的原 始创新研发的国家高新技术企业。公司以复杂骨盆骨折等高难度创伤骨科手术为核心突破点，开发出包括罗森 万相 ® 智能化骨科手术机器人系统在内的多款数字化医工融合产品。该系统通过 人工智能规划、术中实时3D导航和自动复位等技术辅助临床手术，大幅提升手术精准度和效率。公司已获得 多项荣誉，如北京市专精特新"小巨人"企业，并完成多轮融资，支持产品研发与商业化。目前，其机器人已在 全国多家医院应用，完成数百例手术，并推动技术向国际市场扩展。 2 . 产品名称 ： 磁 共 振 影 像 增强器 申请人：清超卓影（北京）医疗科技有限公司 清超卓影（北京）医疗科技有限公司成立于2023年1月，是一家专注于超材料在医学成像领域研发与应 用的高科技企业。公司聚焦磁共振成像（MRI）技术创新，其"磁共振影像增强器"通过 ...

Core Viewpoint - Haier Biomedical's subsidiary, Haier Blood Technology Chongqing Co., Ltd., has received the first EU MDR certification for its plasma separation equipment, marking a significant milestone for the company in expanding its market presence in Europe and globally [2][5]. Group 1: Certification and Compliance - The MDR compliance assessment is a prerequisite for medical devices entering the EU market, ensuring product safety, performance, and post-market surveillance [5]. - The successful certification of Haier's plasma separation equipment demonstrates the company's adherence to EU regulations in product design, manufacturing, and quality control [5]. Group 2: Company Statements and Future Plans - Haier Biomedical's General Manager, Liu Zhanjie, emphasized that obtaining the MDR certificate is a recognition of the company's quality management system and positions Haier Blood Technology to compete globally [7]. - The company aims to leverage this certification as a new starting point to promote Chinese manufacturing solutions in global healthcare [7]. Group 3: TÜV Rheinland's Role - TÜV Rheinland serves as a notified body for EU medical device regulations, providing compliance assessments and certifications that enhance the competitiveness of "Made in China" products in international markets [8]. Group 4: Company Overview - Haier Blood Technology Chongqing Co., Ltd. was established in 2001 and specializes in comprehensive solutions for blood and blood component collection, processing, testing, storage, transportation, and usage [8]. - The company's main products include plasma separation machines, disposable centrifuge plasma separators, and various types of blood bags and related medical devices [8].

近日， FineHeart 宣布，已完成 C 轮融资首轮交割 ，本轮首期募集资金 4,070 万美元（约合人民币 2.8亿 ） ，用于推进其用于心力衰竭治疗的下一代植入式装置 FlowMaker® 的临床与产业化进程。 在本轮融资完成后，FineHeart 通过私募资本与欧洲公共资金的组合，累计获得约 9,660 万美元 的资金支持。 此次融资不仅为公司后续研发与商业化提供直接资金保障，也成为撬动 IPCEI Tech4Cure 项目公共资金的重要杠杆。根据披露，FineHeart 作为该项目的核心参与方 之一，还将获得 4,800 万欧元 的非稀释性资助，用于支撑欧洲有源植入式医疗器械（AIMD）关键技术体系的建设。 # 聚焦心衰治疗 ：下 一代植入式 装置的技术路径 # 市场背景：LVA D 体 系之 外的另一 种可能 FineHeart 的核心产品 FlowMaker ，是一款面向重度心力衰竭患者的 全植入式心输出量加速装置 。与当前主流的左心室辅助装置（LVAD）不同，FlowMaker 的设 计目标并非完全替代心脏泵血功能，而是 与心脏自身收缩节律协同工作 ，在保留原生心功能的前提下提供辅助支持。 ...

在医疗器械行业，无论是企业招聘，还是个人职业选择，真正的风险往往不是"招不到人"或"找不到工作"，而是—— 双方看似合适，却难以长期共存。 不少合作，开始得很快，结束得也很快。 就像一场"闪婚闪离"。 那么，企业与候选人，究竟该如何判断彼此是否真正适合长期合作？ 哪些信号在面试阶段就已经存在，却常被忽略？ 哪些误判，在入职后才逐渐显现？ 哪些结构性错位，即使双方都优秀，也注定难以匹配？ 本次分享，我们邀请一位长期服务于医疗器械行业的资深猎头，从多年真实招聘与入职案例出发，围绕"企业与候选人的双向匹配"，系统讨论： 分享嘉宾： 方超，Powerlinks管理合伙人，专注医疗器械领域招聘16年，助力逾百家500强外企、国内上市公司和各阶段初创公司的全模块人员搭建和配置。 活动时间： 2026年1月21日星期三上午10:30，苏州，工业园区 活动规模：20人左右 报名方式：粘贴链接到浏览器填写，或点击文末阅读原文 https://hdxu.cn/1Eftz 企业如何判断一个候选人是否真正适合自身阶段与文化 候选人如何识别一家企业是否适合自己长期发展 面试中最容易产生的双向误判 不同企业阶段下，对人才的真实需求差异 ...

企业简介，看起来只是几段文字，但真正写好它，往往意味着： 你对公司战略是否清楚， 对产业位置是否有判断， 对未来方向是否有认知， 也是否理解同行与市场在看什么。 因为企业简介， 不仅是"我是谁"， 更隐含着： 本次活动，我们针对医疗器械公司，希望讨论清楚三件事 1. 企业简介，写给谁看？ 不同阅读对象，关注点完全不同： 企业简介首先是一种 认知工具 ，而不是资料堆砌。 我在产业中的位置 我未来可能走向哪里 投资人关心：对标对象、成长空间、退出路径 媒体关心：行业位置、故事价值 销售关心：是否好记、好讲 合作方关心：你能提供什么价值 2. 不同资料中的企业简介，本质是不同功能的传播工具 但现实中，我们常常用同一套写法应对所有场景。 3. 企业简介如何写，才能被记住？ 我们将重点讨论： 例如： 在融资BP中，如果企业简介不能帮助投资人迅速找到二级市场对标对象，就很难判断企业未来的市值空间与 退出路径；而投资人也需要一套清晰、好讲的逻辑，向LP解释这是一家怎样的公司。 这些判断，往往就发生在企业简介的几段文字中。 主题 企业简介，其实不简单 —— 一次关于"企业如何被理解"的传播讨论 官网企业简介：第一认知入口 融 ...

带量采购政策正在深刻改变医疗器械市场格局。在止血材料领域，传统产品同质化竞争激烈，而临床对高效、 安全、易用的创新产品需求持续增长。这种供需矛盾为具有技术突破能力的国产企业提供了发展窗口。 # 集采新动向：从价格竞争到价值优选 京津冀 " 3+N " 联盟采购项目是近期医疗器械集中采购的重要进展。与早期集采聚焦于成熟、用量大的低值 耗材不同，此次止血材料 的带量采购项目， 显示出集采政策向更高附加值产品领域延伸的趋势。 京 津冀 " 3+N "联盟止血材料类医用耗材带量联动采购项目 结果近期揭晓，多家企业的产品成功入围。此次 | | | | | 京津冀"3+N"联盟止血材料类医用耗材带量联动采购中选结果公示表 | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 序号 ▼ | 注册证号 | 申报企业名称 | | 使用部位 = 注册证管理类别, | 采购品种 | ■ 最小竞价单位拟中选价格(元)▼ 最小竞价单{▼ | | | 94 | 国械注准20143141857 | 青岛中惠圣熙生物工程有限公司 | 体内使用 | 三类 | 2-49 | 3. ...

Group 1: Acquisition Details - Boston Scientific announced a definitive agreement to acquire Penumbra for $374 per share, corresponding to an enterprise value of approximately $14.5 billion [2] - The transaction will be completed through a combination of cash and stock, with cash accounting for about 73% and stock for about 27% [2] - The cash portion will be financed through internal funds and new debt, with the deal expected to close in 2026 pending shareholder approval [2] Group 2: Penumbra's Business Overview - Penumbra, based in Alameda, California, focuses on thrombosis-related diseases and neurovascular interventions, with a projected revenue of approximately $1.4 billion for 2025, reflecting a year-on-year growth of about 17% [3] - The company's products address various critical conditions, including acute ischemic stroke, pulmonary embolism, deep vein thrombosis, acute limb ischemia, myocardial infarction, and aneurysm-related interventions [3] Group 3: Technological Strategy - Penumbra's strategy centers on mechanical thrombectomy rather than drug thrombolysis or energy-assisted methods, with its most recognizable technology being the Computer-Assisted Vacuum Thrombectomy (CAVT) system [4] - The Lightning Bolt and Lightning Flash product series enhance operational consistency and controllability in complex clinical scenarios, such as pulmonary embolism and peripheral deep vein thrombosis [6] Group 4: Complementary Product Lines - Penumbra has developed a peripheral embolization system for rapid blood flow intervention in scenarios requiring hemorrhage control or vascular occlusion, complementing its thrombectomy systems [7] - This dual product line allows Penumbra to address both "thrombus removal" and "blood flow blockage" needs, enhancing its market position [7] Group 5: Industry Context - The acquisition of Penumbra is part of a broader trend of adjacent expansion in the vascular intervention field by large medical device companies, focusing on extending existing customer bases and clinical pathways [13] - Boston Scientific previously established a market presence in the peripheral vascular and pulmonary embolism sectors through its EKOS product line, which utilizes ultrasound-assisted thrombolysis [14][16] Group 6: Strategic Implications - The acquisition is viewed as a means to complement Boston Scientific's existing product offerings rather than replace them, as it addresses different stages in the stroke treatment continuum [16][18] - The recent acquisition of Inari Medical by Stryker has raised the profile of the peripheral thrombosis and pulmonary embolism markets, leading to a reassessment of growth potential and valuation for companies like Penumbra [19][20]

Core Viewpoint - Qingfeng Biotech has completed a multi-million Pre-A round financing, led by Baiyun Fund, to advance its AI+ laboratory automation initiatives, including capacity expansion and the development of AI models [1] Market Status - The laboratory automation market is entering a stable growth phase, with AI becoming a key driver. The global market size is projected to reach approximately $8-8.3 billion in 2024, $9 billion in 2025, and $14-18 billion by 2030, maintaining a compound annual growth rate (CAGR) of 7-9% [2] - In China, the AI-related laboratory market is expected to grow from approximately 15-20 billion RMB in 2024 to 20-25 billion RMB in 2025, and reach 50-60 billion RMB by around 2030, with a CAGR of 15-20% [4] Company Overview - Qingfeng Biotech, established in 2018, focuses on the R&D, production, and sales of life science automation equipment and integrated platforms. The company emphasizes system-level design and platform delivery capabilities rather than just single-device solutions [5] - The OutStanding large-scale automated pipetting workstation integrates high flexibility, modularity, and standardization, supporting multiple life science applications. It has successfully bid for a project valued at nearly 2 million RMB per unit, competing with imported brands [5] AI Integration - Qingfeng Biotech is enhancing its laboratory automation applications by integrating AI capabilities, focusing on the development of BioFlow AI and Supervisor AI models for experimental process management and data-driven optimization [6] - The trend of "AI+ smart laboratories" is evolving from single-point algorithms to core capabilities throughout the entire experimental process, aiming to reduce human error and improve operational efficiency [7] Post-Financing Strategy - The company's development focus is shifting from individual equipment to a systematic construction of "automation platforms + AI capabilities." The financing will be directed towards capacity, algorithms, application centers, and platform capabilities, highlighting the importance of scalable delivery and long-term technological evolution [8]