持续葡萄糖与酮体监测系统
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26款医疗器械,进入创新通道!
Xin Lang Cai Jing· 2025-12-09 13:43
Core Viewpoint - The article discusses the approval of 26 innovative medical devices by the National Medical Products Administration (NMPA) and local regulatory bodies in China, focusing on advancements in various medical technologies and their potential impact on healthcare [34]. Group 1: Overview of Approved Devices - A total of 26 medical devices have entered the innovative approval channel, with 10 products approved by the NMPA and 16 by local authorities [34]. - The applications are primarily concentrated in Shanghai, Jiangsu, and Guangdong provinces, covering 11 categories of medical devices, mainly focusing on active surgical instruments, passive implantable devices, and passive surgical instruments [36]. Group 2: Notable Devices and Companies - **Renal Artery Ultrasound Ablation System**: Developed by Shenzhen Maiwei Medical Technology Co., Ltd., this device targets resistant hypertension through ultrasound energy to ablate renal nerves [41]. - **Bipolar High-Frequency Ultrasound Dual-Output Surgical Device**: Created by Shanghai Yichao Medical Device Co., Ltd., this device innovatively adjusts energy output based on tissue characteristics [42]. - **Kidney Puncture Surgical Navigation System**: Offered by Shenzhen Weide Precision Medical Technology Co., Ltd., this system utilizes AI for 3D reconstruction to assist in surgical navigation [45]. - **Transcatheter Aortic Valve Replacement Surgical Assistance System**: Developed by Zhicheng Medical Technology (Jiaxing) Co., Ltd., this system features modular design and tactile feedback for improved navigation in complex vascular conditions [45]. - **Disposable Hematoma Aspiration Device**: Produced by Shanghai Micron Medical Technology Co., Ltd., this device addresses the high mortality and disability rates associated with brain hemorrhages [46]. - **Proton Therapy System**: Launched by Meisheng Medical Equipment Co., Ltd., this system is recognized for its precision in targeting tumors while protecting surrounding tissues [47]. - **Continuous Glucose and Ketone Monitoring System**: Developed by Shenzhen Silicon-based Sensor Technology Co., Ltd., this system enhances diabetes management through continuous monitoring [48]. - **Biodegradable Zinc Alloy Internal Fixation System**: Created by Hunan Huaxiang Medical Technology Co., Ltd., this innovative product is aimed at addressing the need for biodegradable materials in medical applications [50]. - **Biological Artificial Blood Vessel**: Offered by Haima Medical Technology (Suzhou) Co., Ltd., this product is notable for its ability to produce small-diameter engineered blood vessels [51]. - **Disposable Fistula Closure Device**: Developed by Nanwei Medical Technology Co., Ltd., this device fills a gap in the market for post-operative fistula management [51]. - **Soft Tissue Release System**: Created by Ruilan Medical Technology (Shanghai) Co., Ltd., this product is designed for soft tissue expansion and cutting [52]. Group 3: Emerging Technologies - **Ultrasound Endoscopic Image Processing Device**: Developed by Hunan Kaimai Medical Technology Co., Ltd., this device enhances visualization during endoscopic procedures [57]. - **Self-Testing Mobile ECG Device**: Offered by Shenzhen Rui'Aixin Mobile ECG Information Service Co., Ltd., this portable device allows users to conduct ECG tests anywhere [58]. - **Non-Invasive Intracranial Pressure Monitoring Device**: Developed by Dongnao Medical Technology (Tianjin) Co., Ltd., this device utilizes infrared light density analysis for pressure detection [59]. - **Transcranial Electrical Stimulation Treatment System**: Created by Shanghai Quellan Technology Co., Ltd., this system is aimed at assisting in the treatment of brain injury-related disorders [59]. - **Cryogenic Wart Removal Spray**: Launched by Xiamen Zhongke Medical Device Co., Ltd., this product employs gas expansion for rapid freezing of warts [60]. - **Nasal Hemostasis Kit**: Developed by Hangzhou Yuan'ao Biotechnology Co., Ltd., this kit is designed for use in surgical and emergency settings [60]. - **Optical Coherence Tomography Scanner for Ophthalmology**: Offered by Gao Shi Innovation Technology Co., Ltd., this device is used for diagnosing retinal diseases [61]. - **Oral Suction Holder**: Created by Sichuan Lanqi Medical Device Co., Ltd., this product is designed for dental applications [62]. - **Ultrasound Imaging Processing Software**: Developed by Feiyinuo Technology (Changsha) Co., Ltd., this software aids in the analysis and storage of ultrasound images [64].
最新!7款医疗器械进入创新通道
思宇MedTech· 2025-11-28 09:40
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].