Group 1 - Recently, two medical devices from Suzhou have entered the national special approval channel for innovative medical devices, allowing for prioritized review and faster clinical application [1] - Suzhou has a total of 65 innovative medical devices in this fast-track approval process, accounting for 10% of the national total and 60% of Jiangsu province [1][2] - The National Medical Products Administration (NMPA) has announced that 14 innovative medical devices have been approved for special review, including a near-distance radiation therapy planning software and a catheter-based radiofrequency ablation system [1] Group 2 - The near-distance radiation therapy planning software is designed to dynamically guide equipment for improved treatment outcomes [1] - The catheter-based radiofrequency ablation system aims to address the treatment challenges of hypertrophic obstructive cardiomyopathy and has received breakthrough device designation from the FDA [1] - The special review process for innovative medical devices is intended to accelerate the domestic replacement of high-end medical devices and break the import monopoly [1][2]

Core Viewpoint - The article highlights the advancements in the medical technology sector, particularly focusing on innovative medical devices that have received special review status from the NMPA, indicating a growing trend in the industry towards innovation and regulatory support [1]. Company Summaries - Shenzhen Mindray Bio-Medical Electronics Co., Ltd. is a leading global medical device supplier, established in 1991, with a revenue of 36.73 billion yuan in 2024, reflecting a 5.1% year-on-year growth, and a net profit of 11.67 billion yuan, up 0.7% [5]. - Wuxi Reiming Vision Technology Co., Ltd. specializes in the research and production of artificial lenses, having developed advanced hydrophobic acrylic materials and received CE certification for its products, indicating its strong R&D capabilities [6]. - Shenzhen Gamma Knife Technology Co., Ltd. has been focused on high-end medical equipment, particularly in radiation therapy, since its establishment in 1993, showcasing its commitment to innovation in the medical technology field [7]. - Suzhou Puno Medical Technology Co., Ltd. is a national high-tech enterprise founded in 2020, dedicated to the development of products related to tumor brachytherapy, emphasizing its strong R&D capabilities and innovative approach [10]. - Hangzhou Aijinglun Technology Co., Ltd. is an innovative ophthalmic medical device company established in 2015, known for its unique suspension-type intraocular lens, which fills a gap in the market for high-degree correction lenses [13]. - Beijing Shanning Kezhi Medical Device Co., Ltd. focuses on biodegradable zinc alloy technology, with products entering clinical trials, showcasing its innovative approach in the biomedical field [15]. - Medtronic, a global leader in medical technology founded in 1949, operates in over 70 disease areas, providing lifelong treatment solutions for chronic disease patients [18]. - Shanghai Yangshan Biotechnology Co., Ltd. was established in 2023, collaborating with top hospitals and dental clinics, indicating its strong market positioning in the dental sector [19]. - Xiamen Shide Medical Equipment Co., Ltd. emphasizes innovation in surgical instruments, having obtained numerous patents and certifications, and is recognized for its diverse product line [20][21]. - Guangzhou Xinhanglu Medical Technology Co., Ltd. focuses on innovative cardiac electrophysiology products, with a unique four-dimensional mapping system that enhances treatment precision [22]. - Shanghai Jinkui Medical Device Co., Ltd. specializes in cardiovascular interventional materials, having developed several pioneering products and maintaining strong R&D partnerships [23]. - Guokexin Medical Technology Co., Ltd. is engaged in the development of advanced medical equipment for boron neutron capture therapy, marking a significant advancement in cancer treatment technology [24]. - Shanghai Ruining Biotechnology Co., Ltd. focuses on high-end biomedical materials, with a strong emphasis on innovation and collaboration with leading cancer treatment centers [25]. - Suzhou Sainasi Medical Technology Co., Ltd. is dedicated to cardiac electrophysiology, providing innovative solutions and a comprehensive product line for the medical field [26].