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]

国家药监局:又有10款医疗器械进入创新通道 - Reportify