植入式神经刺激系统

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进入创新通道!植入式神经刺激系统
思宇MedTech· 2025-04-14 10:56
报名:首届全球眼科大会 | 议程更新 报名:首届全球骨科大会 | 议程更新 报名:首届全球心血管大会 | 奖项申报 合作伙伴征集:2025全球手术机器人大会 2025年3月26日,NMPA公布了创新医疗器械特别审查申请审查结果公示(2025年第3号),有 14款产品 进入创新通道。其中包括, 博睿康医疗科技(上海)有限 公司 申请的 植入式神经刺激系统 。 # 研究背景 随着全球老龄化加剧, 神经退行性疾病 (如帕金森病、癫痫等)的患病率不断攀升,植入式神经刺激系统的需求也日益增长。近年来,医疗技术的飞速发展显著提 升了植入式神经刺激系统的治疗效果与安全性,使其在慢性疼痛、抑郁症、帕金森病、癫痫、尿失禁、肌张力障碍等众多疾病的治疗中展现出广阔的应用前景。 植入式神经刺激系统 是一种通过电刺激神经系统来治疗疾病的医疗设备,通常由 电极、脉冲发生器和电池 等组成。它通过精确的电信号调节神经活动,从而改善或 恢复功能。根据不同的应用领域,植入式神经刺激系统可分为 脑深部刺激器、脊髓刺激器、迷走神经刺激器、骶神经刺激器、胃刺激器 等。 # 植入式神经刺激系统分类 脑深部刺激(DBS) 脑深部刺激是通过植入脑深部特定核 ...
红杉医疗被投企业多款医疗大模型顺利落地|Healthcare View
红杉汇· 2025-03-27 15:53
Group 1 - Shenzhen People's Hospital, Shukun Technology, and Huawei have formed a deep collaboration to deploy the DeepSeek-R1 model and the "Shukun Kun" multi-modal healthcare model, enhancing the hospital's medical and research capabilities [3] - The platform equipped with DeepSeek and "Shukun Kun" medical models will provide comprehensive research support, enabling rapid construction of multi-modal databases and offering data analysis tools for researchers [5] - The global first peritoneal dialysis model was launched by Shenzhou Medical and Sun Yat-sen University First Affiliated Hospital, utilizing advanced DHC+DeepSeek dual-engine architecture for precise understanding and processing of complex information in the field [7] Group 2 - Yingxi Intelligent has deployed its first bipedal humanoid robot named "Supervisor" in its AI-driven fully automated drug discovery laboratory, aimed at enhancing laboratory operations [10] - The innovative implantable neurostimulation system by Boruikang has passed the review by the National Medical Products Administration, marking a significant advancement in medical technology [12] - The commercial production base for small nucleic acid drugs by Zhaowei Technology has officially commenced operations, featuring advanced equipment and a total designed capacity of 48 production lines [20] Group 3 - Zhengxu Bio's self-developed base editing drug CS-101 has successfully treated a Malaysian patient with beta-thalassemia, marking another significant achievement in gene editing therapy [23] - The OCT intravascular imaging catheter developed by Weiguang Medical has received registration approval for dual indications, enhancing diagnostic efficiency in coronary and carotid artery diseases [26] - The first platelet-related cell new drug XJ-MK-002 has been granted orphan drug designation by the FDA for treating congenital thrombocytopenia, showcasing innovation in rare disease treatment [28] Group 4 - The new generation PI3Kα inhibitor JYP0035 capsule has received approval for clinical trials, aimed at treating PIK3CA mutated, HR-positive, HER2-negative breast cancer, indicating strong R&D capabilities [30] - The first domestically developed antibacterial fishbone suture line has been approved by the NMPA, representing a breakthrough in surgical materials [43] - The flexible ultrasound probe project led by Suzhou Nolaisheng Technology has been approved as a national key research and development project, highlighting advancements in ultrasound technology [39]
最新!14款医疗器械进入创新通道
思宇MedTech· 2025-03-26 07:38
报名:首届全球眼科大会 | 议程更新 报名:首届全球心血管大会 | 奖项申报 报名:首届全球骨科大会 | 奖项评选 合作伙伴征集:2025全球手术机器人大会 2025年3月26日,NMPA公布了创新医疗器械特别审查申请审查结果公示(2025年第3号),有14款产品进入创新通道。 | | 公众号 邮箱登录 内部培训系统 使用指南 网站地图 | | | --- | --- | --- | | mnr 国家药品监督管理局医疗器械技术审评中心 Center For Medical Device Evaluation . NMPA | 请输入关键字 Q | | | G 机构概况 信息公开 法规文件 | 审评科学 办事大厅 | | | 创新医疗器械特别审查申请审查结果公示(2025年第3号) | | | | | | 发布时间:2025-03-26 | 1. 产品名称:人类3号和10号染色体异常细胞检测试剂盒(荧光原位杂交法) 公司已获得两项国家创新医疗器械审批,先后被评为国家高新技术企业、江苏省潜在独角兽企业、江苏省双创人才企业等,申请、授权国家发明专利 36 项、国际 专利 5 项。 申请人:珠海圣美生物诊断技术有限公 ...