放射治疗计划软件
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国家药监局:又有10款医疗器械进入创新通道
Xin Lang Cai Jing· 2026-02-04 12:20
Core Viewpoint - The National Medical Products Administration (NMPA) has approved 10 innovative medical devices for special review procedures as part of the third batch of applications for 2026 [1][2] Group 1: Approved Innovative Products - The following innovative products have been granted special review status: 1. Chronic Obstructive Pulmonary Disease Assessment Software by Bojiang Life Sciences (Shanghai) Co., Ltd. [1][2] 2. Ultrasound Therapy Device by Shenzhen Tengfu Medical Technology Co., Ltd. [1][2] 3. Transcatheter Artificial Tricuspid Valve by Edwards Lifesciences LLC [1][2] 4. Transcatheter Artificial Tricuspid Valve by Jiangsu Zhenyi Medical Technology Co., Ltd. [1][2] 5. Ultrasound Thrombolysis Catheter and Stent System by Shanghai Tengfu Medical Technology Co., Ltd. [1][2] 6. Radiation Therapy Planning Software by Guoke Ion Medical Technology Co., Ltd. [1][2] 7. Implantable Cardioverter Defibrillator by Chuangling Cardiac Rhythm Management Medical Device (Shanghai) Co., Ltd. [1][2] 8. Peripheral Balloon Expandable Stent System by Zhejiang Guichuang Medical Technology Co., Ltd. [1][2] 9. Thoracoabdominal Endoscopic Surgical System by Zhi Guan Medical Company [1][2] 10. Coronary Sinus Balloon Counterpulsation System by Shanghai Micron Melody Medical Technology Co., Ltd. [1][2]
最新!10款医疗器械进入创新通道
思宇MedTech· 2026-02-02 09:58
Core Viewpoint - The article discusses the recent approval of 10 innovative medical devices by the National Medical Products Administration (NMPA) in China, highlighting the advancements in the medical technology sector and the companies involved in these innovations [1]. Group 1: Innovative Medical Devices - The first product is a software for assessing chronic obstructive pulmonary disease, developed by Bojiang Life Sciences (Shanghai) Co., Ltd., which focuses on digital biomarkers and therapies for chronic disease management [2]. - The second product is an ultrasound therapy device from Shenzhen Tengfu Medical Technology Co., Ltd., which specializes in interventional devices for pulmonary embolism treatment [3]. - The third product is a transcatheter artificial tricuspid valve developed by Edwards Lifesciences, a leading company in structural heart disease devices [4][5]. - The fourth product is an ultrasound thrombolysis catheter and stent system from Shanghai Tengfu Medical Technology Co., Ltd., aimed at providing safer treatment options for venous thromboembolism [9][11]. - The fifth product is a radiation therapy planning software from Guoke Ion Medical Technology Co., Ltd., which focuses on the industrialization of medical heavy ion technology [12]. - The sixth product is an implantable cardioverter-defibrillator from Chuangling Heart Rhythm Management Medical Device (Shanghai) Co., Ltd., which aims to provide high-quality heart rhythm management products [13]. - The seventh product is a peripheral balloon-expandable stent system from Zhejiang Guichuang Medical Technology Co., Ltd., which specializes in high-end vascular interventional devices [14]. - The eighth product is a thoracoabdominal endoscopic surgical system from Intuitive Surgical, a global leader in robotic-assisted minimally invasive surgery [15][16]. - The ninth product is a coronary sinus balloon counterpulsation system from Shanghai Micron Melody Medical Technology Co., Ltd., which focuses on coronary intervention devices [17].