经观健康 术后冠脉造影，回旋支支架术后未见狭窄 姚道阔主任医师操作血管介入 手术控制系统与DSA联动，完成PCI手术 本次手术是北京友谊医院顺义院区成功完成的首例血管介入手术控制系统辅助经皮冠状动脉介入治疗手术。1月20 日，国产血管介入手术控制系统辅助完成经皮冠状动脉介入治疗手术的安全性和有效性全国多中心临床试验，首都 医科大学附属北京友谊医院分中心启动会顺利召开。标志着这一国家创新医疗器械正式在友谊医院西城院区、顺义 院区、通州院区三院区同步开展临床验证。宋现涛教授担任分中心主要研究者（PI），全面指导项目实施。手术的 顺利完成，彰显出医院在心血管介入诊疗领域的专业实力，以及对创新医疗技术的发展与应用。 血管介入手术控制系统介绍 2月4日，北京友谊医院顺义院区心内科顺利完成首例机器人（血管介入手术控制系统）辅助下经皮冠状动脉介入治 疗。该患者是一名65岁男性，因冠心病、不稳定型心绞痛入院，检查提示冠脉双支病变、回旋支重度狭窄，符合机 器人辅助手术指征。在北京友谊医院副院长、心血管中心主任宋现涛教授的支持与指导下，心内科主任医师姚道阔 团队精准操作，仅用时20分钟便顺利完成支架植入，手术圆满成功，患者恢复情 ...

Core Insights - The article discusses the registration and quality management system assessments for medical devices in Guangdong Province, highlighting various companies and their products that have undergone evaluations and received approvals or required modifications [2][5]. Group 1: Company Registrations - Guangdong Weinuodun Medical Technology Co., Ltd. received approval for its medical ozone therapy device on November 3, 2025 [3]. - Guangdong Baisheng Medical Instrument Co., Ltd. passed the evaluation for high-frequency surgical equipment on November 3, 2025 [3]. - Shenzhen Kefu Biotechnology Co., Ltd. was approved for its continuous glucose monitoring system on November 4, 2025 [3]. - Guangzhou Wanfu Biological Technology Co., Ltd. received approval for its hepatitis B virus nucleic acid testing kit on November 10, 2025 [3]. - Shenzhen Karman Medical Equipment Co., Ltd. was approved for its intracranial pressure sensor and cerebrospinal fluid drainage set on November 12, 2025 [3]. Group 2: Quality Management System Assessments - The Guangdong Provincial Drug Administration is implementing a quality management system assessment for Class II medical devices, with results communicated to applicants via SMS or web queries since May 2022 [5]. - Companies such as Shenzhen Aibo Hechuang Medical Robot Co., Ltd. received approval for their vascular intervention surgery control system on November 27, 2025 [5]. - Guangdong Tiancheng Tianmei Medical Technology Co., Ltd. was approved for absorbable surgical sutures on November 19, 2025 [4].