医疗器械
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脑机接口迎政策技术双催化,三博脑科、美好医疗20CM两连板!全市场规模最大医疗ETF(512170)20日新高!
Xin Lang Cai Jing· 2026-01-06 02:01
Group 1 - The medical ETF (512170) opened high on January 6, rising over 1% and reaching a 20-day high, with real-time transaction volume exceeding 350 million yuan. The ETF recorded a daily increase of over 5%, marking five consecutive days of gains [1][5] - Brain-computer interface stocks, including Sanbo Brain Science and Meihua Medical, both hit the 20% daily limit up, achieving two consecutive boards. Conversely, the CXO sector saw a pullback, with Tigermed falling over 1% [1][5] Group 2 - On January 5, 2026, Elon Musk announced that Neuralink plans to start large-scale production of brain-computer interface devices, advancing the commercialization of the technology. Concurrently, the National Medical Products Administration held a meeting to expedite the review and approval of related medical devices [3][6] - According to CITIC Securities, China's brain-computer interface technology is relatively advanced globally, with potential to cultivate leading companies in the sector. This could enhance the valuations of related listed companies in the secondary market and stimulate financing in the primary market, creating a synergy between capital and industry development [7] - Zhongtai Securities noted that the pharmaceutical sector is expected to rebound in 2025 after four consecutive years of decline, driven by the realization of innovative drug export logic and industry recovery post-policy reform. Certain areas of the medical device sector may also see a reversal of difficulties [7]
人脑工程板块继续冲高,三博脑科等多股开盘涨停
Bei Jing Shang Bao· 2026-01-06 01:47
北京商报讯(记者 丁宁)1月6日,延续前一交易日大涨走势,人脑工程板块涨幅明显。 具体来看,三博脑科、美好医疗开盘"20cm"涨停,爱朋医疗、翔宇医疗等高开超10%。 ...
建发致新1月5日获融资买入727.58万元,融资余额1.06亿元
Xin Lang Cai Jing· 2026-01-06 01:45
Group 1 - The core point of the news is that Jianfa Zhixin experienced a stock price increase of 3.11% on January 5, with a trading volume of 126 million yuan, despite a net financing outflow of 451.27 million yuan for the day [1][2] - On January 5, Jianfa Zhixin had a financing buy amount of 7.2758 million yuan, with a total financing balance of 106 million yuan, representing 6.98% of its market capitalization [2] - The company, established on August 30, 2010, specializes in medical device direct sales and distribution, providing centralized operation services for medical consumables to hospitals [2] Group 2 - Jianfa Zhixin's revenue for the period from January to September 2025 reached 14.861 billion yuan, reflecting a year-on-year growth of 10.18%, while the net profit attributable to shareholders was 230 million yuan, up 45.01% year-on-year [2] - As of December 19, the number of shareholders for Jianfa Zhixin was 28,900, a decrease of 4.56% from the previous period, with an average of 1,747 circulating shares per person, an increase of 4.78% [2]
港股复锐医疗科技高开逾4%
Mei Ri Jing Ji Xin Wen· 2026-01-06 01:39
每经AI快讯,复锐医疗科技(01696.HK)高开逾4%,截至发稿涨4.55%,报4.6港元,成交额3.86万港元。 ...
迈瑞医疗1月5日获融资买入2.86亿元,融资余额38.05亿元
Xin Lang Zheng Quan· 2026-01-06 01:26
机构持仓方面,截止2025年9月30日,迈瑞医疗十大流通股东中,香港中央结算有限公司位居第三大流 通股东,持股1.17亿股,相比上期减少1473.63万股。易方达创业板ETF(159915)位居第五大流通股 东,持股1169.35万股,相比上期减少195.91万股。华泰柏瑞沪深300ETF(510300)位居第六大流通股 东,持股1033.58万股,相比上期减少48.07万股。华宝中证医疗ETF(512170)位居第七大流通股东, 持股947.20万股,相比上期减少154.04万股。易方达沪深300医药ETF(512010)位居第九大流通股东, 持股759.59万股,相比上期减少237.30万股。景顺长城新兴成长混合A(260108)位居第十大流通股 东,持股748.00万股,相比上期减少52.00万股。易方达沪深300ETF(510310)退出十大流通股东之 列。 责任编辑:小浪快报 资料显示,深圳迈瑞生物医疗电子股份有限公司位于广东省深圳市南山区高新技术产业园区科技南十二 路迈瑞大厦1-4层,香港湾仔皇后大道东183号合和中心46楼,成立日期1999年1月25日,上市日期2018年 10月16日,公司主营 ...
“一带一路”俄罗斯骨科器械市场消费结构分析及投资潜力评估预测报告(2026版)
Sou Hu Cai Jing· 2026-01-06 01:20
Group 1: Market Overview - The global orthopedic medical device market reached $59.36 billion in 2023 and is projected to grow to $62.22 billion in 2024, with an expected market size exceeding $94 billion by 2032, maintaining a stable annual growth rate of 5.3% [2] - In China, the orthopedic medical device market expanded from 16.4 billion yuan in 2016 to 48.4 billion yuan in 2023, with a compound annual growth rate (CAGR) of 16.72%, and is expected to surpass 80 billion yuan by 2026 [3] - The aging population in China is driving an increase in orthopedic disease prevalence, with approximately 55% of individuals over 60 suffering from osteoarthritis, and the rate rising to 70% for those over 70 [3] Group 2: Economic Factors - China's per capita healthcare expenditure increased from 1,164.55 yuan in 2015 to 2,547 yuan in 2024, with an annual growth rate of about 9.5% [4] - The per capita health expenditure in China rose from 4,669.34 yuan in 2019 to 6,425.32 yuan in 2023, reflecting an annual growth rate of approximately 8.3% [4] - The rise in health awareness and income levels among residents is expected to further stimulate the orthopedic market [4] Group 3: Competitive Landscape - Foreign brands dominate the high-end orthopedic device market in China, with Johnson & Johnson holding a 22.5% market share, followed by Stryker at 15.8% and Medtronic at 13.6% in 2024 [5] - Domestic companies like Weigao Orthopedics, Dabo Medical, and Sanyou Medical are gaining market share through technological innovation and competitive pricing [5] - The market is experiencing increased competition due to centralized procurement policies, leading to significant price reductions and pressure on smaller companies [5][6] Group 4: Industry Trends - The orthopedic medical device market is characterized by both diversification and concentration, with leading companies solidifying their market positions through technological advantages and brand influence [6] - Innovations in minimally invasive surgery, precision treatment, and new materials are accelerating within the industry, driven by increased R&D investments [4][6]
医疗器械标识不符合强制性标准,如何处罚?
Xin Lang Cai Jing· 2026-01-06 00:55
(来源:中国医药报) 转自:中国医药报 □ 肖文玉 马佳川 张嘉宇 案情 2024年12月,T省药监局收到T省医疗器械检验中心出具的检验报告。报告显示,H公司生产的超声波治 疗仪不符合《医用电气设备 第2-5部分:超声理疗设备的基本安全和基本性能专用要求》(以下简称 《专用要求》)201.7.2.101装置型号的特殊标记中"治疗头上应标注以W为单位的额定输出功率,以cm2 为单位的有效辐射面积,波束不均匀性系数,波束类型,预期的治疗头与设备特定发生器的匹配(若适 用,见201.7.9.2.1的最后一项)和其唯一性的序列号"的要求,综合判定为不合格。 经查,H公司生产的超声波治疗仪治疗头确实未按要求标明相关信息,但相关信息在产品使用说明书中 已标明。经检验,未发现产品额定功率不符合要求,抽检的其他项目也均符合相关要求。 分歧 对于H公司的行为如何定性,执法人员存在不同观点。 第一种观点认为,H公司生产的超声波治疗仪经检验不符合强制性标准,违反了《医疗器械监督管理条 例》(以下简称《条例》)第三十五条第一款中医疗器械注册人、备案人、受托生产企业应当"严格按 照经注册或者备案的产品技术要求组织生产,保证出厂的医疗器 ...
《优先审批高端医疗器械目录(2025版)》发布
Xin Lang Cai Jing· 2026-01-06 00:55
Core Points - The National Medical Products Administration (NMPA) has released the "Priority Approval Directory for High-end Medical Devices (2025 Edition)" which includes eight types of products such as boron neutron capture therapy systems and high-field magnetic resonance imaging equipment [1][2] - The directory aims to implement the State Council's directive on deepening the reform of drug and medical device regulation to promote high-quality development in the pharmaceutical industry [1] - The NMPA will prioritize the approval process for the listed medical devices according to specific regulations, ensuring a streamlined review process for these innovative products [1] Summary by Categories Product Categories - The directory includes eight high-end medical devices: 1. Boron neutron capture therapy systems 2. High-field magnetic resonance imaging equipment 3. Medical electron accelerators 4. Implantable brain-machine interface medical devices 5. Endoscopic surgical control systems 6. Transcatheter tricuspid valve replacement or repair systems 7. Implantable glaucoma drainage devices for minimally invasive glaucoma surgery (MIGS) 8. Membrane oxygenators for ECMO [1] Regulatory Framework - The NMPA has established the directory in accordance with the "Regulations on the Registration and Filing of Medical Devices" and the announcement on optimizing lifecycle supervision to support the innovative development of high-end medical devices [1] - The approval process will follow Article 73, Item 3 of the Medical Device Registration and Filing Management Measures, allowing for expedited review of applications for the listed devices [1] Implementation and Future Adjustments - The directory will take effect immediately upon publication, with the NMPA indicating that it may adjust the list as necessary in the future [2]
医疗器械出口销售证明管理规定调整优化
Xin Lang Cai Jing· 2026-01-06 00:55
(来源:中国医药报) 《规定》分别对拟出口已在中国境内注册或者备案的医疗器械、拟出口未在中国境内注册或者备案的医 疗器械两种情形的申请主体、所需材料等进行了明确。 《规定》还从多方面为医疗器械出口提供便利。例如,取消了证件效期最长不超过两年的限制,明确医 疗器械出口销售证明有效日期不应超过申报资料中企业提交的各类证件最先到达的截止日期,第一类医 疗器械的出口销售证明有效期不超过3年;限定出口证明办理时限不超过20个工作日,同时明确办理过 程中药品监管部门开展现场检查以及企业整改时间不计入时限;鼓励药品监管部门实行网上办理。此 外,明确出口销售证明的电子证明与纸质证明具有同等效力。 《规定》强调申请人应当落实质量管理体系要求,保证医疗器械出口信息的可追溯。《规定》要求,出 具证明的部门应当对申报资料的真实性、合法性、有效性以及生产企业的生产质量管理规范符合性情况 进行审核,必要时可以开展现场检查。同时,列出了不予出具出口销售证明的具体情形。 《规定》还增加了医疗器械出口销售证明英文编号和规则、调整了证明出具形式、细化了证明内容等。 转自:中国医药报 本报北京讯 (记者张一) 近日,国家药监局修订发布《医疗器械出 ...
A股罕见12连阳,原因找到了
21世纪经济报道· 2026-01-06 00:41
记者丨易妍君 编辑丨张星 2026年,A股旗开得胜,三大股指在首个交易日(即1月5日)悉数上涨。 这一天,上证指数重返4000点之上,日线更是迎来罕见的12连阳,为"春季躁动"预期下的A股市场再添"一把火"。 市场热点轮番活跃,脑机接口、保险、存储器等题材相对强势;CRO、模拟芯片、基因检测、虚拟人等概念也有不错的表现。 展望后市,前海开源基金首席经济学家、基金经理杨德龙判断,2026年科技牛行情有望延续。 多因素助推A股"开门红" 1月5日,A股市场高开高走,喜迎2026年"开门红"。 截至当日收盘,上证指数涨1.38%,报4023.42点;深证成指涨2.24%,报13828.63点;创业板指的涨幅接近2.9%,报3294.55点。科 创50指数则大涨4.41%,北证50指数上涨1.8%。 当天,全部A股成交额达2.57万亿元,较前一个交易日增加了5000多亿元。全市场近4200只个股上涨。 在业内人士看来,A股"开门红"得益于多重积极因素的共振。 "节后市场情绪在假期港股走强的带动下显著回暖; 资金层面,市场对年内保险资金等长期增量资金入市抱有期待,同时全球流动 性宽松预期也提振了风险偏好;更深层次的驱动 ...