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进入创新通道!染色体核型辅助诊断软件
思宇MedTech· 2025-05-08 09:36
Core Viewpoint - The article highlights the advancements in chromosome karyotyping diagnostic technology by DIAGENS Co., Ltd., emphasizing the importance of their automated systems in improving diagnostic efficiency and accuracy for genetic disorders [3][10][19]. Group 1: Product Overview - DIAGENS has developed the MetaSight® automated cell microscopy scanning system and the AutoVision® intelligent chromosome karyotyping analysis system, which together facilitate rapid and precise diagnosis of chromosome abnormalities [3][11]. - The AutoVision® system can assist in diagnosing thousands of chromosome abnormalities, reducing the report generation time to 4-7 days and decreasing human labor to one-seventh to one-tenth of traditional methods [3][10]. - The systems have received certifications from NMPA, CE, and FDA, indicating their compliance with international medical device standards [3][10]. Group 2: Clinical Significance - Chromosome karyotyping is crucial for assessing genetic material status, aiding in prenatal diagnosis, reproductive health, and understanding genetic disorders [4][6]. - Key populations for chromosome karyotyping include individuals with unexplained growth or developmental delays, reproductive dysfunction, exposure to harmful substances, couples with habitual miscarriages, and older pregnant women [4][6]. Group 3: Technological Innovations - The AutoVision® system utilizes AI algorithms for automatic identification, classification, pairing, and detection of chromosome abnormalities, achieving an accuracy rate exceeding 99.6% [9][10]. - The MetaSight® system can scan a single slide in just 4 minutes and supports high-throughput scanning of up to 200 slides at once, significantly enhancing laboratory efficiency [11][16]. - Recent collaborations with Zhejiang University have led to the development of the HomNet™ algorithm, which automates the identification of chromosome structural abnormalities, addressing a critical challenge in chromosome analysis [18]. Group 4: Company Background - DIAGENS Co., Ltd. was established in 2016 and focuses on AI in medical imaging and chromosome analysis, with a commitment to solving core technical challenges in the reproductive health sector [19]. - The company has invested nearly 100 million yuan in R&D, with 39.8% of its expenses allocated to innovation, and has established partnerships with several prestigious universities [19][20].
最新!9款医疗器械进入创新通道!
思宇MedTech· 2025-04-27 15:05
正式报名:首届全球心血管大会 | 重磅亮点 合作伙伴征集:2025全球手术机器人大会 现有取得注册证产品: 取石网篮、肠道支架及输送系统、胆道支架及输送系统、颅内支撑导管等。 2024年临床项目处于快速有序进行中,并以计划启动"下静脉取栓装置用于治疗深静脉血栓形成的安全性和有效性的前瞻性、多中心、随机、开放、平行对 照、非劣效临床试验"。 2025年4月27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4号),有9款产品进入创新通道。 1. 产品名称:颅内静脉窦取栓支架 申请人:北京弘海微创科技有限公司 北京弘海微创科技有限公司成立于2017年11月份,是一家以植/介入医疗器械研发、生产、销售于一体的创新型平台公司,聚焦于神经、外周、消化、泌 尿、呼吸等植/介入领域的医疗器械研发,为医患提供完整的治疗方案。公司拥有全球独创的工艺技术,通过自主研发的设备,开发出具有卓越性能的植/介 入医疗器械。 2. 结核分枝杆菌复合群耐药基因突变检测试剂盒(可逆末端终止测序法) 申请人:广州市金圻睿生物科技有限责任公司 广州市金圻睿生物科技有限责任公司(简称"金圻睿")于2016年成立,聚焦于精准医疗体 ...