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多重利好催化!脑机接口板块活跃,心玮医疗涨逾11%
Sou Hu Cai Jing· 2025-12-29 12:01
12月29日,受多重利好催化,港A脑机接口概念股集体冲高。 在港股市场,截至收盘,心玮医疗-B(06609.HK)涨11.7%,脑洞极光-B(06681.HK)涨5.71%,南京熊猫电子股份 (00553.HK)涨4.84%,微创脑科学(02172.HK)涨3.29%。 在A股市场,截至收盘,三博脑科(301293.SZ)涨7.21%,翔宇医疗(688626.SH)涨7.16%,创新医疗(002173.SZ)涨 3.76%,爱朋医疗(300753.SZ)涨1.8%,熵基科技(301330.SZ)涨1.2%。 消息面,12月28日,第五届脑科学前沿与产业大会暨深圳脑机接口博览会启幕,备受瞩目。开幕式上,粤港澳大湾区脑科 学与中枢神经疾病AI创新联盟启动;总规模11.6亿元的脑科学产业基金落地,构建覆盖早期到成长期的科技金融支持体 系。 近期,脑机接口领域频频传来利好,不仅为板块上涨注入动力,也为赛道内企业带来了更多的想象空间。 首先,在政策端,支持脑机接口政策密集出台。12月26日,国家药监局发布《优先审批高端医疗器械目录(2025版)》, 植入式脑机接口医疗器械被列入。 此前,工信部等七部委联合发布《关于推动 ...
最新政策!8类高端医疗器械明确加速审批
思宇MedTech· 2025-12-29 09:11
近日, 国家药品监督管理局 (NMPA) 发布 《优先审批高端医疗器械目录(2025版)》 ,共有 8 类高端医疗器械 被纳入优先审批范围。与以往不同的是,这一目 录并非单纯的"技术清单",而更像一次明确的监管表态: 在安全有效前提下,为真正处于关键窗口期的高端技术争取时间与确定性 。 从具体入选方向看,这 8 类产品横跨 肿瘤放疗、影像设备、介入治疗、手术机器人、神经调控与生命支持等 多个高复杂度赛道,既包含国内尚处空白的前沿技 术,也覆盖已有产品但仍存在明显临床或技术边界的成熟领域。 "优先审批"并不等同于降低标准,而是一种 监管资源配置方式的变化 。 在现行医疗器械注册体系下,高端创新器械往往面临技术复杂、临床验证周期长、注册沟通成本高等问题。通过设立高端医疗器械优先审批目录,监管部门释放出 的信号并非"放行",而是: 在满足安全性和有效性要求的前提下,通过提前介入、并行审评和资源倾斜,压缩不必要的制度性时间成本 。 因此,目录本身并不是终点,而是一个 技术被纳入"重点审评视野"的起点 。 # 八类高端医疗 器械 概览 硼中子俘获治疗系统(BNCT) 该系统通过中子与硼药发生俘获反应,产生高杀伤力的次级 ...
今天 A股有望破纪录
商业航天板块行情扩散 今天上午,多元金融、碳纤维、燃气、风电设备等多个板块受益商业航天板块行情扩散,均表现活跃。 | 碳纤维 | | | | | | --- | --- | --- | --- | --- | | 2119.35 2.12% | | | | | | 基金 | 资金 | 新闻 | 成分股 | 板块分析 | | 最新 | 涨幅 ◆ | 5展开分析 | 流通市值 | | | 和顺科技 | 19.99% | 38.4 Z | 58.34 | 融 301237 | | 首板涨停 最终涨停 09:39 | | | | | | 吉林顿谷 | 54.8 亿 | 17.29 | 16.82% | 融 920077 | | 光威复材 | 319亿 | 38.82 | 11.33% | 融 300699 | | 神剑股份 | 10.02% | 117亿 | 14.49 | 融 002361 | | ○エ○折 = ☆ ] 是 收 ] [ ] 1 | | | | | 在这岁末年初的交替阶段,A股市场迎来两个"惊喜"。 一是商业航天板块强者恒强的走势,成为市场人气最高的板块。 今天上午,多元金融、碳纤维、燃气、风电设备等 ...
今天,A股有望破纪录!
天天基金网· 2025-12-29 05:23
上天天基金APP搜索777注册即可领500元券包,优选基金10元起投!限量发放!先到先得! 在这岁末年初的交替阶段,A股市场迎来两个"惊喜"。 一是商业航天板块强者恒强的走势,成为市场人气最高的板块。 今天上午,多元金融、碳纤维、燃气、风电设备等板块表现活跃,这些看似"不相干"的板块,背后 却因为商业航天板块交易逻辑扩散,串联了起来。 二是上证指数的连阳走势。 今天 上午, 上证指数继续上涨,日线迎来"9连阳 " 。截至12月26 日,上证指数今年以来的最长连阳纪录是"8连阳 " ,共发生两次:一次发生在4月11日—22日, 另一次在8月4日—13日。 今天 下午,上证指数若保持涨势,将迎来日线"9连阳 " ,打破此前 的"8连阳 " 纪录。 今天上午,算力产业链、消费电子、有色金属等板块上涨,锂电产业链回调。截至午间收盘,上证 指数上涨0.31%,深证成指上涨0.03%,创业板指下跌0.32%。 | 上证指数 | 深证成指 | 创业板指 | | --- | --- | --- | | 3975.92 | 13607.39 | 3233.53 | | +12.24 +0.31% | +3.50 +0.03% ...
港股异动 | 政策支持脑机接口发展 心玮医疗-B(06609)涨超12% 脑动极光-B(06681)涨近8%
智通财经网· 2025-12-29 02:23
Core Viewpoint - The brain-machine interface sector is experiencing a surge in stock prices following the release of a new regulatory framework by the National Medical Products Administration (NMPA) in China, which includes a list of prioritized high-end medical devices for approval [1] Group 1: Stock Performance - Heartway Medical-B (06609) saw a price increase of 12.22%, reaching 54 HKD [1] - Brain Dynamics-B (06681) rose by 7.78%, trading at 6.79 HKD [1] - Nanjing Panda Electronics (00553) increased by 7.14%, with a price of 4.65 HKD [1] Group 2: Regulatory Developments - On December 26, the NMPA published the "Priority Approval List for High-End Medical Devices (2025 Edition)," which includes eight products, such as implantable brain-machine interface devices [1] - The list outlines the technical parameters and expected uses of the products [1] - The NMPA is actively promoting faster and better market entry for brain-machine interface devices through a dedicated working meeting [1] Group 3: Market Outlook - Guotai Junan Securities notes that recent policies have shown strong support for innovation in medical devices [1] - The brain-machine interface sector has diverse application scenarios and rich product and research pathways, indicating significant future potential [1] - With the support of product registration and medical insurance policy initiatives, commercialization is expected to accelerate [1]
一批高端医疗器械列入优先审批目录
Xin Lang Cai Jing· 2025-12-26 21:02
据新华社电 记者12月26日从国家药监局获悉,国家药监局日前组织制订《优先审批高端医疗器械目录(2025 版)》,将医用电子加速器、植入式脑机接口医疗器械、内窥镜手术控制系统等纳入其中。 据了解,国家药监局对目录中的医疗器械注册申请按照《医疗器械注册与备案管理办法》第七十三条第 (三)项情形实施优先审批。国家药监局医疗器械技术审评中心按程序对目录产品注册申请材料进行审 核,审核拟定予以优先审批的,公示审核结果无异议后进入优先审批程序;审核拟定不予优先审批的, 告知注册申请人原因并按常规程序办理。 ...
国家药监局将一批高端器械列入优先审批目录
Xin Hua She· 2025-12-26 13:36
据了解,国家药监局对目录中的医疗器械注册申请按照《医疗器械注册与备案管理办法》第七十三条第 (三)项情形实施优先审批。国家药监局医疗器械技术审评中心按程序对目录产品注册申请材料进行审 核,审核拟定予以优先审批的,公示审核结果无异议后进入优先审批程序;审核拟定不予优先审批的, 告知注册申请人原因并按常规程序办理。 记者12月26日从国家药监局获悉,国家药监局日前组织制订《优先审批高端医疗器械目录(2025 版)》,将医用电子加速器、植入式脑机接口医疗器械、内窥镜手术控制系统等纳入其中。 ...
一周大事,盘前必看
Group 1 - The People's Bank of China and six other departments issued guidelines to support new industrialization, focusing on optimizing financial policies for key technology products and enhancing the resilience of industrial supply chains [2] - The guidelines emphasize the development of technology finance, green finance, and digital finance, aiming to support the transformation of traditional industries and the growth of emerging industries [2] - The guidelines also propose improving credit management mechanisms and financial products in the central and western regions to facilitate industrial transfer and resource allocation [2] Group 2 - On August 8, the central bank conducted a 700 billion yuan reverse repurchase operation to maintain liquidity in the banking system, indicating a continued implementation of moderately loose monetary policy [4] - As of the end of July, China's foreign exchange reserves stood at 32,922 billion USD, a decrease of 25.2 billion USD from the end of June, while gold reserves increased to 7,396 million ounces, marking the ninth consecutive month of increase [5] Group 3 - The Ministry of Industry and Information Technology and other departments released implementation opinions to promote innovation in the brain-computer interface industry, focusing on accelerating the development of implantable devices [6] - The Shanghai Municipal Government issued a development plan for the embodied intelligence industry, aiming for breakthroughs in core algorithms and technologies by 2027, with a target industry scale exceeding 50 billion yuan [7][8]
七部门:对植入式脑机接口医疗器械等加大注册指导给予优先支持
Zhong Guo Jing Ji Wang· 2025-08-08 07:27
Core Insights - The implementation opinions released by seven departments, including the Ministry of Industry and Information Technology, aim to promote the innovation and development of the brain-computer interface (BCI) industry by 2027, targeting breakthroughs in key technologies and establishing advanced technical, industrial, and standard systems [1][2] Group 1: Industry Development Goals - By 2027, the BCI industry is expected to achieve breakthroughs in key technologies, with products such as electrodes, chips, and complete systems reaching international advanced levels [1] - The BCI industry is projected to grow significantly, with the establishment of 2 to 3 industrial development clusters and the exploration of new scenarios, models, and business formats [1] Group 2: Application in Healthcare - The implementation opinions emphasize accelerating the application of BCI technology in healthcare, particularly for neurodegenerative and mental diseases, enhancing diagnostic and therapeutic effects [1] - New solutions for rehabilitation needs of patients with limb movement, speech, and sensory deficits will be developed, improving the quality of patient recovery [1] - BCI products will be utilized for real-time monitoring and analysis of brain activity to prevent potential health issues and reduce severe patient risks [1] Group 3: Policy Support and Investment - The opinions call for strengthening technological breakthroughs and application demonstrations in the BCI field, promoting the implementation of major projects and enhancing collaborative research capabilities [2] - Increased investment from national funds, such as the National Manufacturing Transformation and Upgrade Fund and the National SME Development Fund, is encouraged to support the BCI industry [2] - Priority support will be given to the registration of key products like implantable BCI medical devices, along with policies to accelerate industrialization [2]
七部门发布重磅文件 脑机接口产业发展突破有了“施工图”
Core Viewpoint - The joint implementation opinion from seven government departments aims to accelerate the development of the brain-computer interface (BCI) industry, focusing on breakthroughs in implantable devices and establishing a comprehensive industrial ecosystem by 2030 [1][2]. Group 1: Development Goals - By 2027, key technologies in the BCI field are expected to achieve breakthroughs, establishing an advanced technical, industrial, and standard system, with products reaching international advanced levels [2]. - The BCI industry is projected to grow significantly, creating 2 to 3 industrial clusters and fostering new scenarios, models, and business formats [2]. - By 2030, the innovation capability of the BCI industry is anticipated to be significantly enhanced, with the formation of a reliable industrial system and the cultivation of 2 to 3 globally influential leading enterprises [2]. Group 2: Product Development - The opinion emphasizes accelerating the research and development of implantable devices, including high-density neural recording sensors and ultra-low power implantable chips [3]. - It also calls for the innovation of non-implantable devices, promoting lightweight, high-speed, and low-power developments in products like adhesive, ear, and head-mounted interfaces [3]. - The development of auxiliary devices is encouraged, integrating brain signals with other physiological signals to improve interaction control and perception assessment accuracy [3]. Group 3: Policy Support and Market Impact - The opinion outlines the need for enhanced policy support, including increased investment from national funds and the implementation of a "technology-industry-finance integration" initiative [4]. - Recent measures have been introduced to support the registration and pricing of implantable BCI medical devices, with specific costs established for procedures [4]. - The successful clinical trial of an implantable BCI in China marks a significant milestone, positioning the country as the second globally to enter this phase after the United States [4]. Group 4: Industry Collaboration - Industry experts emphasize the importance of collaboration among technology developers, clinical institutions, capital, and government to foster the incubation and realization of research outcomes [6]. - Startups in the BCI field are advised to balance short-term survival needs with long-term innovation goals to maintain investment in core technology development [6].