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最新!2款创新器械获批上市!
思宇MedTech· 2025-08-26 07:26
截至目前,我国上市的创新医疗器械累计 368 项。 | 序号 | 产品名称 | 生产企业 | 批准目期 | 所在地 | 注册证号 | | --- | --- | --- | --- | --- | --- | | 367 | 全自动细胞形态学分析仪 | 深圳望菊等復愿膏 | 2025-8-25 | 深圳 | 国械注准 20253221692 | | 368 | X 射线计算机体层摄影设备 | 东软医疗系统 份 有限公司 | 2025-8-25 | 辽宁 | 国械注准 20253061693 | # 01 全自动细胞形态学分析仪 产品介绍 该产品由 玻片篮输入输出模块、玻片取放模块、显微成像模块、滴油模块、玻片回收模块等和软件(主机应用软件和PC应用软件) 组成,其中PC应用软件包含: 用户交互界面、数据管理模块、基于深度学习的细胞形态分析模块。主要用于对来源于人体外周血液样本中白细胞及有核红细胞分类计数、红细胞形态学分级和血 小板数量估算。 该产品基于 光学显微成像技术和深度学习图像识别技术 ,通过对血细胞的快速定位与高清晰度图像拍摄,获取识别对象的边缘、形状、纹理和颜色等深层次抽象 特征,实现白细胞、红细胞 ...
最新!6款医疗器械进入创新通道
思宇MedTech· 2025-06-03 07:07
Core Insights - The article highlights the upcoming global medical technology conferences scheduled for 2025, including the first Global Aesthetic Technology Conference and the second Global Medical Technology Conference [1][15] - It discusses the recent approval of six innovative medical devices by NMPA, indicating a growing focus on advanced medical technologies in China [1] Company Summaries - **Dunbo Medical**: A high-tech company specializing in the research and production of Class III active implantable medical devices, including single-chamber and dual-chamber wireless pacemakers, and vagus nerve stimulators for heart failure [2] - **Aikang Yicheng Medical**: Established in 2003, this company focuses on spinal fixation systems and has multiple national-level research and development platforms, including a postdoctoral research workstation [3] - **Jiangsu Raman Medical Equipment**: This company specializes in Raman optical biopsy technology, providing real-time optical biopsy solutions for various medical fields, enhancing surgical efficiency and diagnostic accuracy [5] - **Singularity Medical Technology**: Engaged in organ medicine and industrial development, this company has developed a non-ischemic liver perfusion system that significantly improves transplant outcomes by maintaining organ function during transport [8] - **Shanghai United Imaging Healthcare**: Founded in 2011, this company focuses on high-end medical imaging equipment and has a comprehensive product line that includes MRI, CT, and PET/CT systems [9][11] - **Shanghai Pangying Technology**: An innovative medical technology company that has developed the Hairo hair transplant robot, providing a comprehensive solution for hair restoration with advanced visual recognition and precision control [12][14]
最新!9款医疗器械进入创新通道
思宇MedTech· 2025-02-20 03:49
合作伙伴征集:2025全球手术机器人大会 报名:首届全球眼科大会 | 展位有限 1 .产品名称:外周动脉覆膜支架系统 申请人:江苏朴芃医疗科技有限公司 江苏朴芃医疗科技有限公司成立于2019年12月16日,是 臻亿医疗子公司, 其核心产品包括PAFLIVE ® 冠脉冲击波球囊导管系统及外周血管类医疗器械,其中, PAFLIVE ® 冠脉冲击波球囊导管系统利用冲击波技术对冠脉内钙化病变进行预处理,能够安全高效地破坏浅表与深层钙化,恢复血管弹性及血流,填补了国内相关 技术的空白。 2.产品名称:外周药物洗脱支架 申请人:上海畅德医疗科技有限公司 畅德医疗成立于2021年11月,位于上海。公司创始人及核心团队拥有丰富的介入耗材研发、临床注册和商业化经验,对聚焦的行业有深刻的理解。 畅德医疗秉承研发创新的核心理念,致力于高效打造一个能够满足血管疾病微创伤治疗的完整解决方案。公司在下肢动脉狭窄介入治疗、血栓管理、静脉疾病介入 治疗及慢性疾病管理等治疗领域发力,推出了外周血管约束型球囊扩张导管、间歇脉冲加压理疗仪、外周血栓抽吸系统等多款产品。 报名:首届全球心血管大会 | 奖项评选 报名:首届全球骨科大会 | 奖项评选 ...