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最新!又3款创新器械获批上市!
思宇MedTech· 2025-06-27 09:07
Core Insights - The article highlights the upcoming global medical technology conferences and recent approvals of innovative medical devices in China, emphasizing the growth and innovation in the medical technology sector [1][13]. Group 1: Medical Device Approvals - On June 27, 2025, three innovative medical devices received approval from the National Medical Products Administration of China, including a spinal surgery navigation device, a cardiac pulsed electric field ablation device, and a biodegradable magnesium alloy screw [1][2]. - As of now, a total of 360 innovative medical devices have been approved for market in China [1]. Group 2: Spinal Surgery Navigation Device - The spinal surgery navigation device from China-Europe Zhihui (Shanghai) Robot Co., Ltd. is the first in China to utilize micro robotic arm technology, allowing for precise spatial positioning during adult spinal surgeries [3]. - This device significantly reduces the space occupied in the operating room compared to traditional multi-axis robotic arms, enhancing safety and efficiency [3]. Group 3: Cardiac Pulsed Electric Field Ablation Device - The cardiac pulsed electric field ablation device from Shenzhen Maiwei Medical Technology Co., Ltd. is designed for treating drug-resistant, recurrent, symptomatic, and paroxysmal atrial fibrillation [8]. - It is the first device to use nanosecond pulse width high-voltage electric fields for pulmonary vein isolation, providing real-time monitoring and feedback during the ablation process [8]. Group 4: Biodegradable Magnesium Alloy Screw - The biodegradable magnesium alloy screw from Syntellix AG is made from a magnesium-based alloy and is designed to gradually degrade and be replaced by endogenous new tissue within the body [11][12]. - Compared to traditional titanium or steel implants, this product claims to reduce surgical time, costs, pain, and infection risks by half [12].
AI接管诊疗链条,眼科医生还剩下什么?
思宇MedTech· 2025-06-27 09:07
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 曾经,医学AI最擅长的是发现早期病变、提示可疑病灶;如今,它已经开始给出结构性判断、制定干预路 径,甚至手术后随访、患者教育和依从性管理。 从AI判读OCT影像、预测儿童近视发展趋势,到术后通过App远程督促患者用药、记录视力变化,越来越多 的"细节工作"正由医生转交给算法和系统平台完成。 "医生还是主角吗?"这个问题,如今不再出现在手术机器人面前,而是落在更庞大、更隐形的辅助系统上。 眼科,作为医疗AI最早落地的领域之一,正是这一趋势的前哨。 而最先感受到冲击的,并不是那些刚毕业的年轻医生,而是那些原本靠 "判断力"、"细致度"、"稳定性" 积累 价值的医生群体。 他们开始发现, 自己过去十几年里打磨出来的某些技能——正在被系统"吞掉" 。 但AI真的在"抢饭碗"吗?还是说,它只是在逼迫整个眼科医生群体,完成一次价值结构的重新排列? # AI接管了"术前思考" 在传统眼科诊疗路径中, 术前决策 ...
重磅!强生医疗原中国区总裁加入国产创新械企
思宇MedTech· 2025-06-27 09:07
谢文坚拥有超过30年的跨国企业管理经验,曾在医疗器械与消费品行业担任多个关键职位,包括强生医疗中国台湾地区总经理、康维德医疗北亚区总经理、上海家 化董事长兼CEO等。他于2006年出任强生医疗中国区总裁,成为强生首位本土化董事长,并在任期内推动公司连续多年实现超过20%的业务增长。 谢文坚在组织重塑、战略转型、跨境拓展和并购整合方面经验丰富,具备深厚的本土洞察力与国际视野。他的加入,被视为 大洲医学迈入"市场与资本双轮驱动"阶 段的关键一步 。 2025年9月3-5日,第三届全球手术机器人大会 2025年6月27日,大洲医学宣布, 原强生医疗中国区总裁谢文坚 正式加入公司,担任董事会成员及首席战略官 。这一人事变动不仅为大洲医学的战略升级释放出 明确信号,也再次体现出本土高端医疗器械企业在吸引国际化管理人才方面的加速进展。 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 # 关于大洲医学 大洲医学由美国哈佛大学医学院归国科学家创办,在3D打印、新材料、生命科学和生物技术领域进行深度交叉融合创 ...
冲击IPO!国产可吸收外科缝线企业
思宇MedTech· 2025-06-27 09:07
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 2025年6月,海南证监局正式受理 百迈科北交所上市辅导备案材料 ,同意辅导备案, 百迈科正式开启IPO 。 | | | | 辅导对象 | 海南百迈科医疗科技股份有限公司 | | | | --- | --- | --- | --- | | 成立日期 | 2007-06-01 | | | | 注册资本 | 4,065.00万元 | 法定代表人 | 杨顶建 | | 注册地址 | 海南省定安县定城镇见龙社区环城南三环路18号 | | | | 控股股东 及持股比 | 控股股东为海南迈迪科医药控股有限公司,持股比例为 48.35% | | | | 倒 | | | | | 行业分类 | C27 医药制造业 | 在其他交易场 所(申请)挂 脾或上市的情 | 新三板挂牌(股票简 称:自迈科;股票代 码: 874640) | | | | 况 | | | 各 注 | 无 | | | # 财务数据 2024年,百迈科 ...
获批FDA!全球首款非金属外周弹簧圈
思宇MedTech· 2025-06-27 09:07
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 近日, 专注于血管栓塞技术 的创新型公司 Embolization 宣布,其研发的 基于 聚合物的 非金属弹簧圈 已获得美国食品药品监督管理局(FDA)510(k)市场准入认证。 该产品适用于 外周血管动静脉栓塞 ,标志着血管栓塞领域的一项技术进步。随着510(k)认证的获得, Embolization计划尽快启动其商业化进程。 血管栓塞是一种微创介入治疗技术,医生 通过导管将细小材料(如线圈、微粒或胶体)注入目标血管,达 到止血、阻断肿瘤供血或修复异常血管的目的 。 由于操作精确、恢复时间短、创伤小,该方法已成为手术的常见替代方案,尤其在 外周血管疾病治疗 中 广泛应用。 弹簧圈 是最常见的 机械性栓塞器材 ,其 经导管引导至目标血管后可发生脱离,随即嵌在血管腔上,进而 阻塞血液流动 。 弹簧圈 通常由铂金、镍钛合金、铬合金等金属材料制成 ,这些材料 具有良好的生物相容性 ,能够在体内 ...
融资近亿元!国产心腔内超声领跑者完成B+轮
思宇MedTech· 2025-06-26 10:04
Core Viewpoint - The article highlights the advancements and market potential of the 4D intracardiac echocardiography (ICE) technology, particularly focusing on Jiangsu Tingsheng Technology Co., Ltd. and its recent achievements in the field of cardiovascular imaging [1][2][10]. Company Overview - Jiangsu Tingsheng Technology, established in 2017, specializes in cardiac electrophysiology and structural heart disease, with a focus on ultrasound technology innovations [28]. - The company has recently completed a nearly 100 million RMB Series B+ financing round, led by Yifeng Capital, to further develop its 4D ICE technology [1][2]. Product Development - Tingsheng Technology's 4D ICE system has achieved significant milestones, including the successful completion of China's first 4D ICE human clinical study on April 29, 2025, marking a new phase in the country's cardiovascular intervention imaging [2][4]. - The 4D ICE system integrates advanced technologies, enabling high-resolution dynamic 3D cardiac modeling and real-time imaging, which enhances surgical precision and reduces risks [9][22]. Clinical Impact - The 4D ICE technology has demonstrated a 62% reduction in radiation exposure time and a 30-minute decrease in total surgical time compared to traditional X-ray fluoroscopy methods [6][7]. - The system's ability to provide comprehensive imaging and measurement capabilities significantly improves procedural efficiency and reduces complication rates during cardiac interventions [7][9]. Market Landscape - The global ICE market was valued at approximately $81.35 million in 2021 and is projected to reach $130 million by 2028, with a CAGR of 6.61% [12]. - In China, the ICE market is rapidly evolving, with a projected growth from $4.43 million in 2021 to $7.69 million by 2028, increasing its global market share from 5.45% to 5.89% [12]. Competitive Environment - The ICE catheter market is competitive, with major international players like Siemens, Johnson & Johnson, and Philips, while domestic companies such as Tingsheng Technology, Suzhou Ice Crystal, and Shenzhen Xinhui Technology are also emerging [13][11]. - Tingsheng Technology's TINGSN Sonic Eyes 10 is the first domestically produced ICE diagnostic catheter approved in China, showcasing the company's commitment to innovation and local manufacturing [16][17]. Future Prospects - The successful development and clinical application of the 4D ICE technology position Tingsheng Technology to enhance its competitiveness in the global market and contribute to the advancement of cardiac intervention techniques [10][28]. - The company aims to leverage its technological advancements to fulfill its vision of becoming a significant player in the medical device industry, particularly in the field of cardiac imaging [10][28].
融资+换帅!创新医疗技术公司加速扩张
思宇MedTech· 2025-06-26 10:04
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 近日,全球脊柱医疗器械公司 Accelus 宣布完成了 其最新一轮融资 ,具体融资金额和条款未公开披露。自公 司成立以来,Accelus已完成 四轮融资 。其中,最大的一轮融资是2024年1月完成的 2000万美元(约合1.4 亿元人民币)的债权融资 ,由Symbiotic Capital领投。 此外,Accelus 宣布任命医疗技术行业资深人士 Bernie Haffey 担任董事会主席 。 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 Haffey于2024年2月 加入Accelus董事会 ,并在2025年5月29日 被任命为董事会主席 ,接替Alex Lukianov。Haffey表示:"我很荣幸担任Accelus的董事会主席,并期待与Kevin及董事会合作,加速公司成为 全球可扩展脊柱植入物市场的领导者。Accelus的创新技术和快速增长的市场地位使其处于有利位置,我致力 于通过引入HPMS框架,推动卓越文化和组织对齐,助力公司实现 ...
重磅合作!西门子医疗打造诊疗一体化新范式
思宇MedTech· 2025-06-26 10:04
Core Insights - The article discusses the establishment of a strategic partnership between Siemens Healthineers and Massachusetts General Hospital (MGH) to create a Treatment Command Center aimed at integrating molecular imaging technology with targeted radiopharmaceutical therapy for precision diagnosis and personalized treatment [2][3][5]. Group 1: Partnership Overview - The Treatment Command Center's mission is to integrate molecular imaging technology, targeted radiopharmaceutical therapy, and real-time data analysis to create a comprehensive management system for diseases such as prostate cancer and neuroendocrine tumors [3][5]. - This collaboration marks a significant milestone in the long-standing partnership of 23 years between Siemens Healthineers and MGH, focusing on high-end imaging technology applications in neuroscience and oncology [6]. Group 2: Technological Innovations - The center relies on two revolutionary PET/CT devices: Biograph Vision Quadra and Biograph Trinion, which represent breakthroughs in both research-grade whole-body imaging and clinical efficiency [9]. - Biograph Vision Quadra is the world's first whole-body PET/CT using ultra-high-performance time-of-flight (TOF) technology, significantly improving image clarity while reducing patient radiation exposure to levels comparable to traditional chest X-rays [12]. - Biograph Trinion is designed for small to medium-sized hospitals, featuring a digital detector that reduces energy consumption by 46% and occupies 30% less space, making it a cost-effective choice for regional medical institutions [15]. Group 3: Clinical and Research Impact - The Treatment Command Center breaks traditional single-diagnosis models by integrating multidisciplinary collaboration, real-time data analysis, and intelligent treatment decision support systems, enhancing patient treatment efficiency [16]. - The center will collect multimodal data to support AI algorithm development and facilitate new targeted drug research, with a global multi-center study on prostate cancer PSMA treatment set to launch in 2025 [16]. Group 4: Market Dynamics - The global PET/CT market is characterized by a dual-track competition between international brands and domestic technologies, with GE Healthcare and Philips leading in innovation while domestic brands like United Imaging and Sino United Health are making significant advancements [17][22]. - GE Healthcare's Discovery series and Philips' Vereos Digital PET/CT are notable for their advancements in imaging quality and radiation dose reduction, catering to sensitive patient populations [19][21]. Group 5: Future Outlook - The Treatment Command Center plans to expand to more affiliated hospitals by 2026, aiming to serve over 2,000 patients and extend its model globally, including Europe and Asia, by 2028 [27]. - Siemens Healthineers aims to enhance its AI-driven treatment response prediction models by integrating more clinical and genomic data, promoting the widespread adoption of precision medicine beyond developed countries by 2030 [27].
超1亿融资!创新生物电子起搏器
思宇MedTech· 2025-06-26 10:04
Core Viewpoint - Ceryx Medical has successfully completed a $15 million funding round to advance the clinical research and miniaturization of its core product, the Cysoni bioelectronic pacemaker, which aims to address chronic heart failure by simulating natural heart rhythms [1][2]. Funding and Recognition - The recent $15 million financing is a critical part of Ceryx's three funding rounds, with previous rounds including £575,000 in seed funding in 2020 and £3.8 million in 2022 [2][5]. - Ceryx has received various accolades for its technological innovations, including the "Business Startup Award" from the Institute of Physics in the UK, and has collaborated with industry leader Osypka Medical for clinical validation [3]. Market Environment and Application Potential - Chronic heart failure (CHF) affects approximately 30 million patients globally and leads to over 1 million hospitalizations annually in Europe and the US, consuming more than 2% of national healthcare budgets [4]. - Despite existing treatments like CRT and ICD, nearly 50% of CHF patients face a mortality risk within five years of diagnosis, highlighting the need for improved therapeutic options [4]. Core Technology - Ceryx's Cysoni system aims to synchronize heart and respiratory rhythms, offering a novel intervention path that complements existing treatments [10]. - The technology is adaptable and could potentially be applied to other conditions such as hypertension, arrhythmias, and spinal cord injuries [10][13]. Clinical Progress - The Cysoni system has received approval from the UK MHRA in 2024 and is currently in the RSA-pace study phase, which evaluates its safety and efficacy in postoperative patients [15]. - A permanent implantable version, Cysoni-XT, is in development, with plans for broader clinical studies starting in 2025-2026 [15]. - Ceryx is also collaborating with Hydrix to develop a portable clinical trial system to enhance early human research efficiency [15]. Company Overview - Ceryx Medical was founded in 2016 and is based in Cardiff, UK, with a team that includes experts in artificial neurons and cardiac neurophysiology [16].
请到北京领奖!麦得科科技、星辰海医疗、神络医疗等21家企业
思宇MedTech· 2025-06-26 10:04
Group 1 - The article discusses the 2024 Global Medical Technology Innovation Awards and the 2024 Global Medical Technology Newcomer Awards, with a ceremony held on June 28 for companies included in the list for the first half of 2024 [1] - Companies that wish to participate in the 2025 awards ceremony on July 17 must fill out a registration form, and failure to participate will be considered as forfeiting the opportunity [1] - The awards are free of charge, but companies are responsible for their own travel expenses [1] Group 2 - The list of awarded companies for the 2024 Global Medical Technology Innovation Awards includes: Mindray Medical, MicroPort Medical, HeartSky Medical, Qiming Medical, Zhenyi Medical, and others [3] - The article provides a link for awarded companies to fill out their information for the awards [4] - The article encourages companies to actively participate in upcoming events organized by the company, including the Second Global Medical Technology Conference on July 17, 2025, and the Third Global Surgical Robot Conference from September 3-5, 2025 [5]