Workflow
X射线计算机体层摄影设备
icon
Search documents
万东医疗(600055.SH)收到一项医疗器械注册证
智通财经网· 2025-11-27 09:22
智通财经APP讯,万东医疗(600055.SH)公告,公司近日收到国家药品监督管理局颁发的《医疗器械注 册证》,相关产品名称为:X射线计算机体层摄影设备。 ...
万东医疗:产品“X射线计算机体层摄影设备”取得注册证
Mei Ri Jing Ji Xin Wen· 2025-11-27 08:25
截至发稿,万东医疗市值为114亿元。 每经头条(nbdtoutiao)——灌水21万亿,高市早苗1.7万亿强化国防!日本负债率已远超债务危机时的 希腊,对美巨额投资致大规模资本外流,"卖出日元成国际趋势" (记者 曾健辉) 每经AI快讯,万东医疗(SH 600055,收盘价:16.27元)11月27日晚间发布公告称,北京万东医疗科技 股份有限公司于近日收到国家药品监督管理局颁发的《中华人民共和国医疗器械注册证》。产品名称 为"X射线计算机体层摄影设备"。 2024年1至12月份,万东医疗的营业收入构成为:医疗器械制造业占比93.68%,其他业务占比6.32%。 ...
万东医疗收到一项医疗器械注册证
Zhi Tong Cai Jing· 2025-11-27 08:19
万东医疗(600055)(600055.SH)公告,公司近日收到国家药品监督管理局颁发的《医疗器械注册 证》,相关产品名称为:X射线计算机体层摄影设备。 ...
万东医疗:获得X射线计算机体层摄影设备医疗器械注册证
人民财讯11月27日电,万东医疗(600055)11月27日公告,公司于近日收到国家药品监督管理局颁发的 《中华人民共和国医疗器械注册证》,产品名称为X射线计算机体层摄影设备。 ...
最新!又7款医疗器械进入创新通道!
思宇MedTech· 2025-10-31 03:58
Core Insights - The article highlights the approval of seven innovative medical devices by the NMPA, indicating a significant advancement in the domestic medical device industry in China [1]. Group 1: Innovative Medical Devices - The self-expanding intracranial drug-eluting stent system developed by Lilan Biotechnology (Suzhou) Co., Ltd. focuses on providing minimally invasive and safe treatment solutions for cerebrovascular diseases, leveraging advanced biomaterials technology [2]. - The implantable wireless brain-machine interface system from Shanghai Ladder Medical Technology Co., Ltd. is designed for applications in motor control, neurological disease monitoring, and sensory restoration, marking a significant innovation in the field [3][4]. - The X-ray computed tomography equipment from Siemens Medical Solutions (Shanghai) Co., Ltd. serves as a major global R&D and manufacturing center for medical imaging devices, contributing to precision medicine and digital diagnosis [5][6]. - The cartilage regeneration scaffold developed by Zhejiang Xingyue Biotechnology Co., Ltd. aims to repair large cartilage defects and represents a major innovation in regenerative medicine, filling a gap in domestic products [6]. - The collagen meniscus implant from Beijing Bansai Technology Co., Ltd. focuses on repairing meniscus injuries and aims to address knee instability issues post-meniscectomy, promoting clinical application of 3D printing technology in orthopedics [7]. - The thyroglobulin (Tg) gene mRNA detection kit developed by Shanghai Ruijing Biotechnology Co., Ltd. provides comprehensive solutions for thyroid cancer diagnosis and monitoring, serving numerous hospitals across multiple provinces [8]. - Guangzhou Weishi Bosheng Biotechnology Co., Ltd. specializes in minimally invasive ophthalmic devices, focusing on innovative products for glaucoma and retinal detachment treatment, emphasizing micro-invasiveness and biocompatibility [8].
“政策+创新”双赋能?医疗器械产业国际化破局
Core Insights - The National Medical Products Administration (NMPA) is enhancing the legal and standard system for medical devices, increasing support for R&D innovation, and improving review and approval efficiency to promote high-quality development in the medical device industry [1] Industry Developments - In the first eight months of this year, Beijing's exports of medical instruments and devices reached 5.83 billion yuan, a year-on-year increase of 21.5% [1] - The overseas market for medical devices is significantly larger than the domestic market, leading to high growth for many companies in international business [1] Innovation and Product Approvals - Under supportive policies, there has been a surge in innovative product approvals in the medical device sector [2] - David Medical's subsidiary received a registration certificate for a disposable endoscopic linear cutting stapler, enhancing the company's product line and core competitiveness [2] - The NMPA approved a new "Extended Depth of Focus Intraocular Lens" from Tianjin Century Kangtai Biomedical Engineering Co., which aims to improve vision correction post-cataract surgery [2] High-End Medical Imaging Equipment - Neusoft Medical's X-ray computed tomography device received approval, featuring higher spatial resolution and multiple energy imaging capabilities [3][4] - The NMPA is actively supporting the innovation of high-end medical devices, including photon-counting CT technology, which represents a significant advancement in imaging [4][5] Company Performance - Weili Medical reported a third-quarter revenue of 446 million yuan, a year-on-year increase of 16.09%, with a net profit of 70.57 million yuan, up 16.31% [6] - Xiangsheng Medical's revenue for the first three quarters was 343 million yuan, a decrease of 5.3%, while its net profit showed a slight decline [6] - Mindray Medical anticipates positive growth in its third-quarter revenue, with international business expected to accelerate [7] International Expansion - Companies are increasingly focusing on internationalization, with Mindray Medical planning to issue H-shares to enhance its global capital operations [8] - Weili Medical is constructing a factory in Indonesia, expected to start shipments by the end of Q1 2026, primarily supplying products to major clients in the U.S. [9] - The international business of medical device companies is projected to surpass domestic business in the future, with many companies transitioning from imitation to leading global innovation [10]
“政策+创新”双赋能 医疗器械产业国际化破局
Core Insights - The National Medical Products Administration (NMPA) is enhancing the legal and standard system for medical devices, increasing support for R&D innovation, and improving review and approval efficiency to promote high-quality development in the medical device industry [1] Group 1: Market Performance - In the first eight months of this year, Beijing's medical instruments and devices exports reached 5.83 billion, a year-on-year increase of 21.5% [1] - Some medical device companies have reported strong Q3 performance, with Weili Medical achieving a Q3 revenue of 446 million, up 16.09% year-on-year [5] - Xiamen Medical reported a revenue of 343 million in the first three quarters, a decrease of 5.3% year-on-year, while its Q3 net profit increased by 41.95% [6] Group 2: Innovation and Product Development - Under supportive policies, Chinese medical device companies are experiencing a surge in innovation, with multiple new products receiving approval [2] - David Medical's subsidiary received a registration certificate for a new type of surgical stapler, enhancing the company's product line and competitiveness [2] - Neusoft Medical's X-ray CT device received approval, offering higher spatial resolution and better clinical imaging capabilities compared to traditional CT [3] Group 3: International Expansion - Companies are increasingly focusing on international markets, with Mindray Medical planning to issue H-shares to enhance its global capital operations [7] - Weili Medical is constructing a factory in Indonesia, expected to start shipments in Q1 2026, primarily supplying products to major US clients [8] - Analysts believe that the international business potential is vast, with many companies experiencing high growth in overseas markets [8]
“政策+创新”双赋能医疗器械产业国际化破局
Core Insights - The National Medical Products Administration (NMPA) is enhancing the legal and standard system for medical devices, increasing support for R&D innovation, and improving review and approval efficiency to promote high-quality development in the medical device industry [1][3] - Medical device exports from Beijing reached 5.83 billion yuan in the first eight months of the year, marking a 21.5% year-on-year increase, indicating significant growth potential in international markets [1] - Several innovative medical devices have recently received approval, showcasing the industry's innovation vitality [2][3] Regulatory Support - The NMPA has issued measures to optimize the regulatory support for high-end medical device innovation, focusing on key areas such as medical robots, high-end medical imaging, and AI medical devices [3] - The approval of advanced imaging devices like photon-counting CT is seen as a major technological breakthrough, significantly improving traditional imaging methods [3] Company Performance - Weili Medical reported a 16.09% year-on-year increase in Q3 revenue, reaching 446 million yuan, and a net profit of 70.57 million yuan, up 16.31% [4] - Xiangsheng Medical's revenue for the first three quarters was 343 million yuan, down 5.3%, but Q3 net profit increased by 41.95% [4] International Expansion - Companies are increasingly focusing on internationalization, with Mindray Medical planning to issue H-shares for further capital strength and global market engagement [6][7] - Weili Medical is constructing a factory in Indonesia, expected to start shipments by Q1 2026, primarily supplying products to major clients in the U.S. [7] - Analysts believe that the international business potential is vast, with many domestic companies experiencing high growth in overseas markets [7]
新华医疗:X射线计算机体层摄影设备获得医疗器械注册证 国内同行业没有公司已取得同类产品的医疗器械注册证
Mei Ri Jing Ji Xin Wen· 2025-10-10 11:00
Core Viewpoint - Xinhua Medical (600587.SH) has received the Medical Device Registration Certificate from the National Medical Products Administration for its X-ray computed tomography equipment, marking a significant achievement as no other domestic company has obtained a similar certification in the industry [1] Company Summary - Xinhua Medical has announced the receipt of a Medical Device Registration Certificate for its X-ray computed tomography equipment [1] - This certification positions Xinhua Medical uniquely in the domestic market, as it is the first company in the industry to achieve this milestone [1] Industry Summary - The announcement highlights a competitive edge for Xinhua Medical in the medical device sector, particularly in the field of imaging technology [1] - The absence of similar certifications among domestic competitors indicates a potential market opportunity for Xinhua Medical to capture [1]
国家药监局:今年以来已批准医疗器械创新产品52个
Group 1 - The National Medical Products Administration (NMPA) has focused on key areas such as medical robots, high-end medical imaging, AI medical devices, and new biological materials to support the innovation of high-end medical devices [1] - In 2023, the NMPA has approved 52 innovative products, bringing the total to 367 approved innovative products to date [1] - The NMPA aims to encourage high-level global medical device products to debut in China, benefiting global public health with more high-quality products [1] Group 2 - Neusoft Medical Systems Co., Ltd. has received approval for its innovative X-ray computed tomography (CT) equipment, which includes various components such as a scanning frame, high-voltage generator, and photon counting detector [1] - The new product is designed for routine CT examinations and supports coronary CT angiography and spectral imaging [1] - The photon counting CT technology represents a significant breakthrough in CT imaging over the past decade, greatly improving traditional CT imaging methods and demonstrating notable clinical application value [1] Group 3 - Shanghai United Imaging Healthcare Co., Ltd. has also received approval for its photon counting CT [2] - The NMPA will continue to implement supportive measures to promote the market entry of more high-quality products [2]