自2015年在深圳市成立以来，北芯生命始终对标国际一流的创新产品，经过近十年的研发创新，自主研 发、生产了一系列智能化心血管精准介入解决方案，其中，核心产品血管内超声（IVUS）系统为中国 首个获批的自主创新60MHz高清高速国产IVUS产品和首个在海外获批上市（欧盟MDR）的国产IVUS产 品；核心产品血流储备分数（FFR）系统为金标准FFR领域内中国首个获批的国产产品和首个在海外获 批上市（欧盟MDR）的国产FFR产品，填补了领域内的国产空白，打破了海外巨头在冠脉生理学、影 像学等领域的长期垄断局面。截至目前，公司已在境内外取得20余张三类医疗器械注册证，实现11款产 品的上市销售。 与此同时，公司发挥创新主体地位，推动产业整体向创新驱动发展，实现核心工艺国产化和关键技术突 破。目前，公司是国内唯一掌握60MHz高频微型超声换能器开发与加工制造技术并实现产业化生产的 企业，也是国内唯一掌握完整的微型MEMS压力传感器模块设计与封装技术的企业，在行业内处于领先 地位，公司成功打造了"高性能信号与图像算法及应用软件平台"以持续推动智能化、便捷化，核心产品 IVUS系统是目前行业独家同时具备领先的IVUS全序列 ...

值得一提的是，近年来北芯生命持续加大研发投入，搭建了微纳器件、介入导管、高性能医疗硬件及算 法软件四大技术平台，覆盖从核心传感器封装、导管加工到图像分析算法全链条能力，是国内唯一掌握 60MHz高频微型超声换能器与微型MEMS压力传感器完整设计及封装技术的企业。 2025年，公司推出首个国产冠脉功能学一体化解决方案、国产首款外周IVUS导管，并在电生理领域完 成脉冲电场消融（PFA）"single-shot"术式的关键突破，研究成果入选2025年欧洲心脏病学会大会突破 性临床研究专场。截至目前，公司累计申请专利超360项，已获得授权180余项，其中发明专利80余项、 PCT国际专利申请14项。 本报讯 （记者王镜茹）7月18日，上交所上市委将审议深圳北芯生命科技股份有限公司（以下简称"北 芯生命"）科创板IPO申请。据悉，北芯生命成立于2015年，是一家专注于心血管精准介入领域的创新 医疗（002173）器械企业，致力于通过高性能有源介入设备，为冠心病、外周血管疾病、房颤等重大疾 病提供智能化精准介入解决方案。 公司深耕冠脉功能学与影像学两大领域，自主研发突破多项"卡脖子"技术，先后推出中国首个自主研发 获批 ...

Group 1 - Shenzhen Beixin Life Technology Co., Ltd. focuses on cardiovascular precision intervention solutions, addressing urgent clinical needs and competing with international innovative products [1] - The company has achieved significant milestones, including the first approved FFR system and the first domestically developed 60MHz IVUS system in China, filling gaps in domestic offerings [1] - Beixin Life has established a comprehensive chain for the independent research, production, and commercialization of high-end active interventional devices and consumables, achieving process localization and international quality standards [1] Group 2 - Beixin Life has received multiple recognitions, including being named a national "Little Giant" enterprise and a high-tech enterprise, with an increasing export share of high-end Class III medical devices [2] - The FFR system received EU MDD certification in March 2020, and the IVUS system is expected to receive EU MDR certification in May 2024, showcasing the company's innovation in medical devices [2] - The company has obtained over 20 Class III medical device registrations and more than 80 authorized invention patents, serving over 1,500 hospitals in more than 50 countries [2] Group 3 - Beixin Life was recognized in the "2024 Chuangyebang 100 Future Unicorn" list, highlighting its innovation capabilities and growth prospects in the high-performance medical device sector [3] - The company aims to continue its leadership in intelligent cardiovascular precision intervention solutions, enhancing product quality and services to improve patient health globally [3] - Beixin Life is committed to fostering the global competitiveness of China's high-performance medical device industry [3]