球囊扩张导管

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河套深圳园区生物医药产业规模超百亿元
Shen Zhen Shang Bao· 2025-07-06 16:51
业聚医疗器械(深圳)有限公司是河套深圳园区首批获得差别化合格评定试点资格的企业。过去,企业 需要提前跟海关确认上门日期,等待工作人员到厂查验。新模式下,通过海关的风险评估和现场考核 后,企业按照规范开展自我验收并向海关提交《质量验收自我声明》,就能以合格保证的方式快速放行 试点货物。 近日,在河套深港科技创新合作区深圳园区内,首批经差别化合格评定的球囊扩张导管正被送往实验 室,这种用于疏通冠状动脉狭窄的精密器械,能在心脏介入手术中帮助恢复血液流动,为冠心病患者带 来"心"的希望。 这一创新措施是深圳海关落实《海关支持河套深港科技创新合作区深圳园区全面深化改革开放若干措 施》的一项积极探索。河套深圳园区生物医药产业发展较为迅速,产业规模已超百亿元。 深圳海关经过深入调研,对经香港进入河套深圳园区并仅在区内使用的法定检验工业品,"一企一策"分 类分级提出差别化合格评定方案,聚焦进口医疗器械品类相对单一企业提出的需求,在风险评估后以合 格保证的方式开展评定试点。据统计,企业在获得差别化合格评定试点资格后,整体查验比例降低 90%,通关时长缩短46%。 (文章来源:深圳商报) "在海关的指导下,我们首次通过合格保证的 ...
专注血管介/植入领域,成都医疗器械企业获国际权威认证
Sou Hu Cai Jing· 2025-07-03 14:21
在现代医疗体系中,医疗器械扮演着至关重要的角色。近日,成都纽创医疗器械有限公司(以下简称"纽创医疗")宣布,公司正式获得由国际权 威认证机构Intertek颁发的ISO 13485:2016医疗器械质量管理体系认证证书。该认证确认纽创医疗在神经介入产品、外周介入产品、冠脉介入产品 领域的管理体系符合国际标准。 ▲纽创医疗 纽创医疗成立于2021年,是一家专注于血管介/植入领域的国家高新技术企业及专精特新企业,其自主研发的纽创飞戈™外周乳突球囊扩张导管是全球首款 同类产品。纽创医疗副总经理闫峰介绍,在此次获得认证的基础上,公司将持续深化海外市场布局,推动海外市场业务开展。 成功通过国际认证 全球化征程正式起航 "ISO 13485是国际主流医疗市场的强制准入基础,有了这张国际通行证,标志着纽创医疗全球化征程的正式启航",闫峰告诉红星新闻记者,这是一个国际 通用的体系认证,不是针对某一个具体产品,而是对整个公司的体系认证。对照相关审核标准,公司此前进行了相应准备,最终成功通过。有了这一认证, 公司就可以为全球医疗机构提供更安全、更可靠的创新医疗器械解决方案。 虽然成立的时间并不长,但纽创医疗已经在所属领域取得一系 ...
蓝帆医疗: 蓝帆医疗股份有限公司公开发行可转换公司债券2025年跟踪评级报告
Zheng Quan Zhi Xing· 2025-06-27 16:15
蓝帆医疗股份有限公司 公开发行可转换公司债券 三、本报告引用的资料主要由该公司或第三方相关主体提供,联合资信 履行了必要的尽职调查义务,但对引用资料的真实性、准确性和完整性不作 任何保证。联合资信合理采信其他专业机构出具的专业意见,但联合资信不 对专业机构出具的专业意见承担任何责任。 www.lhratings.com 联合〔2025〕5291 号 联合资信评估股份有限公司通过对蓝帆医疗股份有限公司主体 及其相关债券的信用状况进行跟踪分析和评估,确定下调蓝帆医疗 股份有限公司主体长期信用等级为 AA-,下调"蓝帆转债"信用等级 为 AA-,评级展望为稳定。 特此公告 联合资信评估股份有限公司 评级总监: 二〇二五年六月二十七日 跟踪评级报告 | 声 明 一、本报告是联合资信基于评级方法和评级程序得出的截至发表之日的 独立意见陈述,未受任何机构或个人影响。评级结论及相关分析为联合资信 基于相关信息和资料对评级对象所发表的前瞻性观点,而非对评级对象的事 实陈述或鉴证意见。联合资信有充分理由保证所出具的评级报告遵循了真 实、客观、公正的原则。鉴于信用评级工作特性及受客观条件影响,本报告 在资料信息获取、评级方法与模 ...
异动盘点0626|周六福早盘高开11.25%,快手涨超 3%,特斯拉跌超 5.3%
贝塔投资智库· 2025-06-26 03:59
Group 1 - Xianruida Medical - B (06669) surged over 18% after receiving registration approval from the National Medical Products Administration for its Armoni-HP® balloon dilation catheter [1] - Meili Tianyuan Medical Health (02373) rose nearly 3% as it announced plans to further acquire a 20% stake in Guangzhou Nairier [1] - Kingdee International (00268) increased over 3% due to adjustments in service fees expected to drive subscription ARR growth by 3% to 5% next year [1] - Sasa International (00178) fell over 5%, with its stock price dropping nearly 20% since its earnings report, as all mainland stores are set to close by the end of June [1] - Jingji Financial International (01468) dropped over 7% after issuing a profit warning, expecting a net loss of no more than HKD 125 million [1] - Kuaishou - W (01024) rose over 3%, with its AI subsidiary achieving an annualized revenue run rate exceeding USD 100 million [1] - Hengyue Holdings (01723) fell over 6% after a profit warning, anticipating a 90% decrease in annual profit attributable to shareholders [1] Group 2 - Military stocks rose against the market trend, with China Shipbuilding Defense (00317) up 7.27%, Aerospace Holdings (00031) up 2.44%, and AVIC (02357) up 1.68% [2] - Victory Securities (08540) soared over 61% as it actively expands into the virtual asset business [2] - Luoyang Molybdenum (03993) increased over 4% amid expectations that a new round of cobalt export bans from the Democratic Republic of Congo may exceed market expectations [2] - China Financial Leasing (02312) surged 229% yesterday and rose another 43% today after a premium acquisition of approximately 35% equity by Meitu's founder [2] - Guotai Junan International (01788) rose over 11% with a trading range of 104%, becoming the first Chinese broker to offer comprehensive virtual asset services [2] - Ganfeng Lithium (01772) increased over 3% as its new battery research institute and Pack integration project is set to begin trial production [2] Group 3 - Innovent Biologics (01801) fell over 4% after announcing a placement of 55 million shares at HKD 78.36 each, a discount of about 4.9% from the closing price on June 25, aiming to raise approximately HKD 4.265 billion [3] - Zhouliufu (06168) opened 11.25% higher on its debut, ranking fifth among jewelry brands in China by store count [3] - Rongchang Biologics (09995) opened nearly 15% lower after licensing its Taitasip to US Vor Bio for an upfront payment of USD 45 million [3] - Western Cement (02233) opened over 5% higher as it plans to sell its Xinjiang company and assets to release operational cash flow for expansion projects [3] - Yingtong Holdings (06883) opened 10.42% lower on its debut, being the largest non-branded perfume group in China [3] Group 4 - BP (BP.US) rose nearly 2% as Shell entered preliminary talks to acquire the company [4] - General Mills (GIS.US) saw its stock price drop over 5.1%, reaching a five-year low [4] - Brain Regen Technologies (RGC.US) fell over 5%, with a market cap shrinking to USD 10.7 billion [4] - Blackberry (BB.US) increased over 12% [4] - Google (GOOGL.US) rose over 2% after launching its first device robot model, Gemini Robotics On-Device [4] - Nvidia (NVDA.US) increased over 4% ahead of its online shareholder meeting, with Loop Capital noting that the AI trend driving Nvidia's stock price remains strong [4] - Chip stocks generally rose, with Supermicro (SMCI.US) up over 8%, Nvidia (NVDA.US) up over 4%, and AMD (AMD.US) up over 3% [4] - Novo Nordisk (NVO.US) fell over 4% as Spain's health ministry investigates whether it violated advertising laws for prescription drugs [4] Group 5 - Therapeutics (NKTR.US) surged nearly 30% after positive results from clinical trials for its eczema treatment [5] - Tesla (TSLA.US) dropped over 5.3% as new car registrations in the EU fell 40.5% year-on-year in May, marking the fifth consecutive month of significant decline [5] Group 6 - US cryptocurrency stocks collectively surged, with Sharplink Gaming (SBET.US) up nearly 6%, Coinbase (COIN.US) up over 3%, and Robinhood (HOOD.US) up over 0.9% [6] - Circle (CRCL.US), a stablecoin giant, continued its downward trend, falling over 10% [6] - Tiger Brokers (TIGR.US) surged nearly 22% as traditional financial institutions explore virtual assets, igniting market enthusiasm [6]
数亿元融资!血管介入械企龙头完成D轮
思宇MedTech· 2025-06-24 09:06
思宇年度活动回顾: 首届全球眼科大会 | 首届全球骨科大会 | 首届全球心血管大会 | 首届全球医美科技大会 即将召开: 2025年7月17日,第二届全球医疗科技大会 2025年9月3-5日,第三届全球手术机器人大会 心未来 2025年6月18日, 广东博迈医疗科技股份有限公司 (简称" 博迈医疗 ")宣布完成 数亿元人民币的D轮 融资 ,由IDG资本领投,阳光融汇资本、未来资产及奇点资本跟投,星桥资本担任独家财务顾问。 这是继2020年高瓴创投领投的数亿元C轮融资后,该公司获得的又一重要资本加持。 本轮融资将进一步加速博迈医疗在研发创新和市场拓展方面的步伐,推动公司向更高水平发展。 投资方对博迈医疗器械的技术实力和市场前景表示高度认可,并期待未来双方在医疗健康领域展开深度合 作。 此次融资是博迈医疗继 2020 年 C 轮融资后的新一轮资本助力。公开资料显示, 公司注册资本已增至 5782.0355 万人民币 ,印证其持续增长的资本价值 。 星桥资本吴志鹏表示:"非常荣幸协助博迈医疗完成本轮融资。公司凭借国际化的战略布局,卓越的产品 性能及高效量产能力,近几年时间内取得了令人瞩目的成绩。我们坚信,此次融资将 ...
四川多支基金完成备案、收获IPO项目 | 机构动态盘点
Sou Hu Cai Jing· 2025-06-12 10:42
Group 1 - In June, several investment funds in Sichuan completed registration and began investing, indicating an active investment atmosphere [1] - Chengdu Jinjiang Jiaozi Digital Equity Investment Fund has a registered scale of 200 million yuan, focusing on the "1+3+3" industrial system in Chengdu [3] - Chengdu High-tech Vision Electronic Information Industry Equity Investment Partnership has been registered, co-funded by Chengdu High-tech Group and Beite Fund [3] - Meishan Industrial Development Investment Guidance Fund is in the process of selecting a sub-fund manager for a 100 million yuan sub-fund focusing on lithium batteries, photovoltaics, and chemical new materials [3] - Sichuan Province's Achievement Transformation Investment Guidance Fund has been launched with a total scale of 5 billion yuan, focusing on various high-tech sectors [4] Group 2 - The Sichuan Province Achievement Transformation Investment Guidance Fund has already invested 150 million yuan in four quality projects in AI and high-end energy equipment [4] - The fund plans to invest over 500 million yuan by 2025, with 39 million yuan already earmarked for ten projects [4] - Chengdu Science and Technology Investment Group's enterprises have been included in the first batch of innovative medical device application pilot lists in Sichuan [5] Group 3 - Sichuan Southwest Jiaotong Railway Development Co., Ltd. was listed on the Beijing Stock Exchange, marking the first IPO project of the Academy Fund under Chengdu Science and Technology Investment [7] - Multiple local funds, including those under Chengdu Science and Technology Investment Group, participated in the investment of Southwest Jiaotong Railway Development [7]
获批上市!又1款外周约束型球囊
思宇MedTech· 2025-06-12 08:16
思宇年度活动回顾: 首届全球眼科大会 | 首届全球骨科大会 | 首届全球心血管大会 即将召开: 2025年7月17日,第二届全球医疗科技大会 2025年9月4-5日,第三届全球手术机器人大会 心未来 近日, 蓝帆医疗 投资孵化的 外周介入板块 上海博脉安医疗科技有限公司 (简称" 博脉安医疗 ") 自主 研发的 金蚕™外周血管约束型球囊扩张导管 (国械注准20253030973)经过国家药品监督管理局审查 批准,正式获批上市。 金蚕™的获批标志着蓝帆医疗布局的外周介入业务线在复杂病变治疗领域再获重大突破。 产品特点 独特设计: 金蚕 ™外周血管约束型球囊扩张导管在半顺应性球囊表面设计了 镍钛记忆合金金属网 结构 ,具有独特 头端螺旋式金属网 设计,避免传统金属丝在回撤时刮擦血管壁,降低血栓风险, 同时保证球囊均匀回抱、安全回撤。 柔顺性增强: 间断镍钛丝网格设计 增强了球囊的柔顺性,确保球囊灵活翻山及通过迂曲病变部位。 随着中国居民生活水平提高以及对健康重视程度的不断提升,未来我国外周动脉介入手术量将不断增长。 近年来,我国外周动脉介入手术量不断增加,因此 国内外周动脉介入支架和球囊市场也将不断扩大 。 根据 ...
获批上市!又1款外周约束型球囊
思宇MedTech· 2025-06-12 08:04
即将召开: 2025年7月17日,第二届全球医疗科技大会 思宇年度活动回顾: 首届全球眼科大会 | 首届全球骨科大会 | 首届全球心血管大会 2025年9月4-5日,第三届全球手术机器人大会 心未来 近日, 蓝帆医疗 投资孵化的 外周介入板块 上海博脉安医疗科技有限公司 (简称" 博脉安医疗 ") 自主 研发的 金蚕™外周血管约束型球囊扩张导管 (国械注准20253030973)经过国家药品监督管理局审查 批准,正式获批上市。 金蚕™的获批标志着蓝帆医疗布局的外周介入业务线在复杂病变治疗领域再获重大突破。 产品特点 独特设计: 金蚕 ™外周血管约束型球囊扩张导管在半顺应性球囊表面设计了 镍钛记忆合金金属网 结构 ,具有独特 头端螺旋式金属网 设计,避免传统金属丝在回撤时刮擦血管壁,降低血栓风险, 同时保证球囊均匀回抱、安全回撤。 柔顺性增强: 间断镍钛丝网格设计 增强了球囊的柔顺性,确保球囊灵活翻山及通过迂曲病变部位。 规格丰富: 球囊适配 0.014" 和 0.018" 导丝系统 ,球囊直径 2.5-6mm ,球囊长度 4-12cm , 可满足临床术中对于不同病变的扩张需求 。 # 产品市场概括 外周动脉疾 ...
成都天府国际生物城诞生国内首个获批上市的精准温控治疗系统
Mei Ri Jing Ji Xin Wen· 2025-06-11 09:43
Core Viewpoint - The article highlights the successful development and approval of the TMS100 system by Zhipu Medical Technology, marking a significant advancement in China's medical device industry, particularly in precise temperature management for critical medical scenarios [1][2]. Company Summary - Zhipu Medical Technology has developed the TMS100 system, which is the first domestic precision temperature control treatment device approved for market use in China [1]. - The TMS100 system utilizes innovative multi-modal adaptive temperature control algorithms and an intelligent risk warning platform, achieving a temperature control precision of ±0.1°C, which meets international standards [1]. - The company aims to provide more efficient and precise treatment tools for clinicians while reducing medical costs and benefiting more patients [2]. Industry Summary - Chengdu Tianfu International Bio-city is focusing on high-quality development in the medical device industry, targeting segments such as in vitro diagnostics, interventional products, medical materials, and life support devices [2]. - The bio-city has attracted major companies like GE Healthcare and MaiKe Bio, fostering the development of significant medical devices that fill gaps in both domestic and international markets [2]. - Future plans for Chengdu Tianfu International Bio-city include promoting the integration of production and research in the medical device industry and accelerating the transformation of scientific achievements [2].
欧盟“设限”中企医疗器械 蓝帆医疗“三角支撑”体系筑牢抗风险壁垒
Zheng Quan Shi Bao Wang· 2025-06-06 08:38
该禁令对蓝帆医疗两大核心业务板块影响可控。从低值耗材板块来看,单个手套标单规模难以触及500 万欧元标准,此项禁令对蓝帆医疗手套业务板块影响较小。预期在欧盟禁令框架下公司手套业务市场运 营节奏仍可保持稳定。 近日,欧盟成员国投票决定限制中国医疗器械制造商进入欧盟庞大的采购市场。如果该决议实施,依据 欧盟的《国际采购工具》(IPI)相关规则,中国企业将在五年内被禁止参与价值超过500万欧元的欧盟招 标。而具体到企业层面过去几年,蓝帆医疗(002382)通过在全球多地布局生产基地的方式,显著提升 了国际贸易政策波动下的抗风险能力,为企业长期稳定发展提供了优势。 同时,公司心脑血管业务板块更是凭借多年积淀的海外生产布局,从源头上规避了欧盟禁令的冲击。目 前蓝帆医疗心脑血管事业部旗下面向国际市场的产品均为海外制造、海外品牌,由位于新加坡和德国的 生产基地完成,这种全球化产能布局从源头上规避了地缘政策风险。在高值医疗耗材领域,公司依托中 国本土研发与制造能力,形成"中国创新+全球交付"模式,在中国、新加坡、德国三地建立起完整的研 发、生产、临床、销售、市场等全流程全团队的本地化部署,形成覆盖中国、亚太、欧洲的"三角支 ...