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全国8款产品进入创新医疗器械特别审批通道
Su Zhou Ri Bao· 2025-09-08 00:43
Core Viewpoint - Eight products have been approved to enter the special approval channel for innovative medical devices in China, with half of them submitted by companies in Suzhou [1] Group 1: Approval Details - A total of eight products have been approved for expedited review, with four of them coming from Suzhou-based companies [1] - The approved products include a controllable diameter TIPS covered stent system, magnesium alloy hollow bone screws, a spinal surgery navigation system, and an implanted deep brain stimulation device [1] Group 2: Regional Contributions - Suzhou has seen significant contributions to the innovative medical device sector, with 70 products entering the special review process, accounting for 11% of the national total and 61% of Jiangsu province's total [1] - Out of these, 34 products have successfully been launched, representing 9% of the national total and 65% of Jiangsu province's total [1] Group 3: Supportive Measures - The Suzhou branch of the provincial drug regulatory authority has established specialized teams to provide tailored services based on the actual needs of companies, contributing to the successful approval of these products [1]
最新!8款医疗器械进入创新通道!
思宇MedTech· 2025-09-06 00:08
Core Insights - The article highlights the approval of eight innovative medical devices by NMPA, indicating a growing trend in the medical technology sector in China [1] Group 1: Company Profiles - Shanghai Xinhong Life Science Co., Ltd. focuses on innovative ultrasound cardiovascular medical technology, leveraging a team with extensive experience in R&D and commercialization [2] - Beijing Bairen Medical Technology Co., Ltd. specializes in high-value medical devices derived from animal sources, with a strong portfolio of 17 approved Class III medical devices [3] - Suzhou Meichuang Medical Technology Co., Ltd. is dedicated to developing innovative medical devices for peripheral vascular and tumor intervention, utilizing proprietary ePTFE materials [4] - Suzhou InnoCore Medical Technology Co., Ltd. is focused on absorbable magnesium alloy materials and advanced orthopedic devices, holding multiple core technologies [4] - Shenzhen Mindray Bio-Medical Electronics Co., Ltd. is the largest medical device manufacturer in China, reporting a revenue of 16.743 billion yuan in the first half of 2025, a decrease of 18.45% year-on-year [6] - Beijing Aikang Yicheng Medical Equipment Co., Ltd. is a pioneer in the commercialization of additive manufacturing technology for orthopedic implants, with several products having received NMPA registration [7] - Chunfeng Huayu (Suzhou) Intelligent Medical Technology Co., Ltd. focuses on innovative spinal surgery robotics, enhancing surgical efficiency through automation [8] - Jingyu Medical Technology (Suzhou) Co., Ltd. specializes in deep brain stimulation systems, with products approved for various neurological conditions [9] Group 2: Market Trends - The approval of innovative medical devices reflects the increasing emphasis on advanced medical technologies in China, addressing clinical pain points and enhancing patient care [1][2][3][4] - The performance of established companies like Mindray indicates a challenging market environment, with significant revenue declines amidst ongoing industry adjustments [6] - The emergence of startups in the medical technology space, such as Chunfeng Huayu and Jingyu Medical, showcases the potential for innovation and growth in specialized medical fields [8][9]