市领导张克、王成明，国家药监局相关司局和直属单位负责同志参加调研活动。（记者 胡建伟） 徐景和强调，医疗器械质量安全关系人民群众的生命健康，药品监管部门要深入贯彻落实党的二十 届三中全会精神，严格落实"四个最严"要求，进一步加强医疗器械质量安全管理体系和能力建设，加强 产品全生命周期质量监管，推进企业落实主体责任，守牢安全底线；进一步健全支持创新医疗器械发展 机制，持续深化医疗器械审评审批制度改革，助推产业创新高质量发展，更好服务公众健康。 10月18日，国家药监局党组成员、副局长徐景和带队赴镇江调研，实地走访江苏鱼跃医疗设备股份 有限公司、丹阳慧创医疗设备有限公司，深入了解医疗器械产品质量控制和研发成果转化情况，对镇江 市医疗器械质量安全监管和创新研发工作给予充分肯定。市委书记马明龙、省药监局局长田丰参加调 研。 ...

Core Viewpoint - Bluefan Medical's half-year report for 2025 shows a net loss of 134.78 million yuan, a reduction in loss by 15.88% year-on-year, while net cash flow from operating activities increased by 407.48% to 335.15 million yuan, indicating a significant improvement in cash generation despite ongoing losses [1] Financial Performance - The cardiovascular division's sales revenue reached 695 million yuan in the first half of 2025, growing over 22% year-on-year, which is a notable increase compared to the 12% growth in the same period of 2024 [1] - The cardiovascular division achieved a turnaround to profitability despite a fair value loss of approximately 122 million yuan due to valuation changes in an associated company, indicating that the net profit from operations reached the billion yuan level [2] Strategic Initiatives - Bluefan Medical has maintained high levels of investment in R&D, leading to the approval of innovative products that meet clinical demands and establish competitive barriers [3] - The company has launched several new products and expanded existing ones into new indications and sales regions, contributing to sustained high gross margins in the high-end medical device sector [3][4] Product Development - The company’s flagship product, the BA9 drug balloon, saw domestic sales increase by over 300% and international sales grow by nearly 90% in the first half of 2025 [4] - The cardiovascular division has nearly 20 self-developed products sold globally, with significant sales growth expected from ongoing commercialization efforts [4] Investment and Ecosystem Development - Bluefan Medical is expanding its reach through investments, including a significant stake in Suzhou Tongxin Medical Technology, a leader in the artificial heart sector [6] - The company has also incubated Shanghai Bomaian Medical, which focuses on comprehensive treatment solutions for cerebrovascular and peripheral artery diseases [7] Global Market Positioning - Bluefan Medical is recognized as the only truly global player in its field, with a sales network covering over 8,000 hospitals in more than 100 countries [8] - The company collaborates with international brands and serves as a platform for domestic medical device companies to enter overseas markets, enhancing their global presence [8][9]

Core Viewpoint - The National Medical Products Administration (NMPA) emphasizes the need to enhance the registration and management of medical devices, focusing on clinical demand and innovation transformation [1] Group 1: Regulatory Focus - The NMPA aims to leverage regional advantages to improve the level of registration and filing work for medical devices [1] - There is a call for a supportive system and mechanism for medical device innovation [1] Group 2: Innovation and Collaboration - The NMPA stresses the importance of strengthening the linkage between research and review processes [1] - Promoting the integration of medical and engineering fields is highlighted as essential for fostering an innovative development ecosystem [1] Group 3: Clinical Value - The goal is to facilitate the transformation of research outcomes with significant clinical value into medical device products [1]