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进入创新通道!产前胎儿畸形超声影像辅助诊断软件
思宇MedTech· 2025-08-14 03:38
招商通知: 2025年9月4-5日,第三届全球手术机器人大会 2025年8月5日,NMPA公布了创新医疗器械特别审查申请审查结果公示(2025年第7号),有 10款产品 进入创新通道。其中包括 广州爱孕记信息科技有限公司 申请的 产前胎儿畸形超声影像辅助诊断软件 。 # 研发背景:出生缺陷防控的"时间赛跑" 在母婴健康领域, 先天性缺陷 依然是全球新生儿与儿童死亡、致残的主要原因之一。 据世界卫生组织最新数据显示,每年约有 24万名新生儿 在出生28天内死于先天性疾病,另有 17万名 1个月至5岁儿童因此离世。最常见的严重缺陷包括 先天性心 脏病、神经管缺陷、唐氏综合征等 。 联合国最新统计显示,2023年全球死产数约 190万例 (妊娠28周及以后),平均每17秒就有一名胎儿在分娩前逝去。 # 产品介绍 广州爱孕记自2016年成立以来,始终聚焦 人工智能在产前超声领域的应用 。其最新推出的 第三代产前超声人工智能辅助诊断系统 (爱孕智声 III代)建立在深度 学习与自动特征提取技术基础之上,专为产前超声动态视频影像设计。 其支持实时同步分析胎儿全身结构、标准切面,并识别常见先天性畸形,实现"GPS导航式"辅 ...
最新!10款医疗器械进入创新通道!
思宇MedTech· 2025-08-05 04:18
Core Viewpoint - The article highlights the upcoming Third Global Surgical Robot Conference scheduled for September 4-5, 2025, and discusses various innovative medical devices and companies involved in the healthcare sector, particularly focusing on advancements in surgical and diagnostic technologies. Group 1: Upcoming Events - The Third Global Surgical Robot Conference will take place on September 4-5, 2025, providing opportunities for doctors, entrepreneurs, and researchers to participate and apply for individual and corporate awards [1]. Group 2: Innovative Medical Devices - Guangzhou Aiyunji Information Technology Co., Ltd. has developed an AI-assisted prenatal ultrasound diagnostic software named Aiyunzhisheng (PAICS), which is designed to enhance efficiency and reduce risks in prenatal screening [2][3]. - Hebei Ruihe Medical Device Co., Ltd. focuses on the development, production, and sales of various medical devices, holding 101 authorized patents and nearly 2000 approved products [5]. - Shanghai Yixin Medical Device Co., Ltd. has created the world's first polymer valve product, SIKELIA®, which successfully completed its first clinical implantation, marking a significant advancement in interventional treatment for valve diseases [6]. - Novocure GmbH specializes in Tumor Treating Fields (TTFields) technology, aiming to extend the survival of patients with aggressive cancers through wearable medical devices [8]. - Hangzhou Wiener Anke Medical Technology Co., Ltd. is innovating in tumor minimally invasive ablation solutions, utilizing high-pressure pulsed electric field technology [9][10]. - Shenzhen Xianjian Technology Co., Ltd. reported a total revenue of 1.304 billion RMB in 2024, with a 2.9% year-on-year growth, driven by its peripheral vascular intervention business [12]. - Suzhou Jiyin Biological Engineering Co., Ltd. has developed a tumor molecular residual disease detection kit, contributing to precision medicine and monitoring in oncology [13]. - Shanghai Shangyang Medical Technology Co., Ltd. focuses on cardiac electrophysiology pulsed electric field ablation technology and has completed a Series A financing round [14]. - Chengxing (Nantong) Medical Device Co., Ltd. specializes in heart-lung intervention devices and has developed several core products since its establishment in 2021 [15]. - Shanghai Yiyu Technology Co., Ltd. reported a revenue of approximately 528 million RMB in its structural heart disease business for 2024, reflecting a 6.4% year-on-year increase [16][17].