最新！7款医疗器械进入创新通道

Core Viewpoint - The National Medical Products Administration (NMPA) has announced the results of the special review application for innovative medical devices, with seven products entering the innovation channel [2]. Group 1: Product Summaries - Product Name: Transcatheter Aortic Valve Replacement (TAVR) Surgical Assistance System Applicant: Zhicheng Medical Technology (Jiaxing) Co., Ltd. The company focuses on the development of transcatheter interventional treatment assistance systems and surgical robots, aiming to enhance operational consistency and safety in TAVR procedures [3]. - Product Name: Continuous Glucose and Ketone Monitoring System Applicant: Shenzhen Silicon-based Sensing Technology Co., Ltd. This high-tech company specializes in electrochemical sensing technology and continuous glucose monitoring systems, providing dynamic monitoring solutions for diabetes and metabolic disorders [4][6]. - Product Name: Biological Artificial Blood Vessel Applicant: Haimai Medical Technology (Suzhou) Co., Ltd. The company is focused on the clinical development of engineered blood vessels and regenerative medicine products, with applications in hemodialysis and peripheral vascular disease treatment [7]. - Product Name: Renal Artery Ultrasound Ablation System Applicant: Shenzhen Maiwei Medical Technology Co., Ltd. This national high-tech enterprise is dedicated to cardiovascular and vascular interventional treatment devices, developing a multi-energy treatment platform for various vascular diseases [8]. - Product Name: Disposable Hematoma Aspiration Device Applicant: Micron Medical Technology (Shanghai) Co., Ltd. A subsidiary of a minimally invasive medical group, the company focuses on neurointerventional solutions for cerebrovascular diseases, enhancing its product offerings in minimally invasive treatments [9]. - Product Name: Disposable Fistula Closure Device Applicant: Nanwei Medical Technology Co., Ltd. This company is a significant manufacturer of minimally invasive medical devices in China, expanding its product range in gastrointestinal and interventional fields [10]. - Product Name: Bipolar High-Frequency Ultrasound Dual Output Surgical Device Applicant: Shanghai Yichao Medical Devices Co., Ltd. The company specializes in the development of high-frequency electrosurgical and ultrasound surgical energy platforms, providing integrated energy solutions for various surgical needs [11].