近日，国家药品监督管理局经审查，批准了强联智创(北京)科技有限公司生产的“颅内动脉瘤手术计划软件”创新产品注册申请。

　　该产品由应用程序和授权文件组成，软件功能模块包括数据加载、显示交互、数据管理、数据处理和日志。产品用于脑血管病患者X射线血管造影三维体层图像的显示、分割、测量和处理，辅助医生在神经介入手术时进行动脉瘤弹簧圈栓塞用的微导管路径和塑形规划。

　　该产品利用医学图像处理技术对颅内动脉瘤患者的X射线血管造影三维体层图像进行处理，实现三维血管重建、动脉瘤分割和自动测量及微导管路径和塑形针形状规划，帮助医生进行术前方案规划。与传统神经介入手术方式相比，该产品可以提升微导管一次性到位率，缩短微导管输送时间，降低术中微导管反复推送对血管刺激导致的并发症发生概率，减少医生、患者X射线辐射时间。

　　药品监督管理部门将加强该产品上市后监管，保护患者用械安全。

　　Recently, the innovative product “software for surgical planning of intracranial aneurysms (Uknow®)” of UnionStrong Technology (Beijing) Inc. is approved for marketing by China NMPA.

　　The product is composed of the application program and authorization files. The software function module includes data loading, display interaction, data management, data processing and log. The product is applied for the display, segmentation, measurement and processing of three-dimensional tomographic images of X-ray angiography for patients with cerebrovascular diseases. It assists doctors in planning the path and shape of the microcatheter used for aneurysm coil embolization during neurointerventional surgery.

　　This product uses medical image processing technology to process the three-dimensional tomography image of X-ray angiography for patients with intracranial aneurysms, to realize three-dimensional vascular reconstruction, aneurysm segmentation and automatic measurement, and to assist in planning the path of the microcatheter and the shape of shaping needle, so as to help doctors with the preoperative planning. Compared with the traditional method of neurointerventional surgery, this product can improve the one-time correct anatomic placement rate and shorten the delivery time of the microcatheter, decrease the incidence of complications caused by the repeated vascular stimulation of microcatheter during operation, and reduce the X-ray radiation time to doctors and patients.

　　The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.