Workflow
消化道内窥镜手术器械控制设备
icon
Search documents
最新!2款创新器械获批上市!
思宇MedTech· 2025-06-23 08:23
Core Insights - The article highlights the approval of innovative medical devices in China, including a disposable endoscopic forceps and a digital PCR analyzer, indicating growth in the medical technology sector [1][2][3][8]. Group 1: Disposable Endoscopic Forceps - Shenzhen Robor Medical Technology Co., Ltd. received approval for a disposable endoscopic forceps, designed for use in endoscopic submucosal dissection (ESD) procedures, allowing for precise manipulation of diseased tissue [3][4]. - The device operates through a flexible robotic arm that enhances the safety and efficiency of ESD, reducing the learning curve for surgeons and promoting wider adoption of the technique [6][7]. - Robor Medical, established in 2015, has developed expertise in medical robotics, leveraging technology from institutions like EPFL and HIT, and aims to integrate robotic solutions into various clinical fields [7]. Group 2: Digital PCR Analyzer - Suzhou Sinafu Medical Technology Co., Ltd. launched a digital PCR analyzer, which quantifies leukemia fusion genes from human blood samples, enhancing diagnostic accuracy [8][9]. - The digital PCR technology partitions the reaction into numerous micro-units, allowing for independent amplification and precise quantification of target nucleic acids, offering advantages over traditional PCR methods [11][13]. - Sinafu Medical, founded in 2018, focuses on creating a complete ecosystem for molecular diagnostic devices and reagents, with its digital PCR system gaining regulatory approval and recognition in the market [12][14].
一季度广东下达3886万元专项资金,重点支持智能机器人、新能源汽车
Group 1: Advanced Equipment Development - Guangdong Province allocated 38.86 million yuan for the first set of major technological equipment, focusing on intelligent robots and new energy vehicles [1] - The advanced equipment sector shows strong industrial clustering, with significant product development and enhanced manufacturing capabilities [1] - Guangdong has cultivated 4 competitive national-level small and medium-sized enterprise clusters and 2 trillion-yuan international competitive industrial clusters in the machinery sector [1] Group 2: Innovations in Aviation - EHang received the first operational qualification certificate for manned civil unmanned aerial vehicles in China, marking a significant step towards commercializing low-altitude manned services [2] - The AG600 amphibious firefighting aircraft developed by AVIC has also received its type certificate, indicating successful market entry [2] - Guangdong plans to accelerate the development of advanced equipment, implementing policies to support new projects and enhance industry collaboration [2] Group 3: Biopharmaceutical Innovations - In Q1, Guangdong approved 3 first-class innovative drugs and 2 third-class innovative medical devices, nearing half of the total approvals for the previous year [3] - The province aims to establish a mechanism for regularly publishing approved innovative drug and device lists and will support the application of these innovations [3] - Guangdong will focus on reforming medical institution preparations as a breakthrough in biopharmaceutical R&D, promoting collaboration between medical institutions and biopharmaceutical companies [3] Group 4: Strategic Planning - The "Three-Year Attack Plan for Key Areas of Advanced Equipment in Guangdong Province (2025-2027)" is being developed, focusing on artificial intelligence, biomanufacturing, marine engineering, and aerospace [4]
最新!又一创新器械获批上市!
思宇MedTech· 2025-03-13 03:59
2025年3月12日,国家药品监督管理局批准了 深圳市罗伯医疗科技有限公司 (简称" 罗伯医疗 ")的 消化道内窥镜手术器械控制设备 (国械注准 20253010539)创新器械注册申请。 截至发 稿日,我国上市的创新医疗器械累计331项。 合作伙伴征集:2025全球手术机器人大会 报名:首届全球眼科大会 | 暂定议程 报名:首届全球心血管大会 | 奖项报名倒计时 报名:首届全球骨科大会 | 奖项报名倒计时 # 市场规模 据世界卫生组织国际癌症研究机构(WHO IARC)发布的数据显示, 在世界十大高发癌症中,消化道肿瘤就占了5个席位。 近年来,我国消化道肿瘤的发病率呈逐年上升趋势, 胃癌、食管癌和结直肠癌每年新发病例约150万,死亡病例约100万 ,近85%的患者在确诊时即为中晚期 , 治疗费用巨大,社会负担沉重。 另据2023年3月《21世纪经济报道》的信息,中国消化道肿瘤的发病率占全部恶性肿瘤发病率的40%,每年因消化道肿瘤死亡的人数几乎占据了所有因肿瘤死亡总 人数的一半左右。 消化道内窥镜手术器械控制设备由电控单元、驱动装置、操作手单元组成,与该公司生产的一次性使用消化道内窥镜组织钳配合使用,适用于食 ...