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【省药监局】监管砺剑护民生 创新赋能筑高地
Shan Xi Ri Bao· 2025-12-02 22:34
"十四五"时期,是陕西省药品监管事业在新时代新征程上迈出坚实步伐的关键五年。五年来,省药 品监督管理局深入贯彻落实党中央决策部署和习近平总书记历次来陕考察重要讲话重要指示,坚持党的 全面领导,以深化开展"三个年"活动为工作抓手,以"四个最严"要求为根本遵循,紧紧围绕"讲政治、 强监管、保安全、促发展、惠民生"工作思路,以党建领航定向,以监管筑牢防线,以创新驱动发展, 以服务赋能产业,交出了一份药品安全形势稳定向好、医药产业活力迸发的亮眼答卷,为筑牢三秦百姓 健康屏障、服务全省经济社会高质量发展作出了积极贡献。 党建引领 锻造忠诚干净担当药监铁军 全面建设社会主义现代化国家,全面推进中华民族伟大复兴,关键在党,关键在人。"十四五"以 来,省药监局始终将坚持和加强党的全面领导贯穿于药品监管工作全过程、各方面,着力锻造一支让党 放心、让人民满意的药品安全监管铁军,以更高标准、更严要求、更实作风为药品监管现代化保驾护 航。 强化理论武装,筑牢思想根基。坚持把理论学习作为党员干部"必修课",严格落实"第一议题"制 度,制定党组理论学习中心组年度学习计划,按季度组织集中学习和专题研讨,充分发挥领导班子"头 雁效应"。深入 ...
最新!4款创新器械获批上市!
思宇MedTech· 2025-09-30 05:03
Core Viewpoint - The article highlights the recent approval of four innovative medical devices by the National Medical Products Administration in China, indicating a growing trend in the development and registration of innovative medical technologies in the country [1][8]. Group 1: Approved Products - The approved products include: 1. "Extended Depth of Focus Intraocular Lens" by Aibono Medical Technology Co., Ltd. [1] 2. "Cardiac Cryoablation Device" and "Single-use Sterile Cryoablation Probe" by Shenyang Pengyue Technology Co., Ltd. [1][8] 3. "Cross-linked Polyisobutylene Aspheric Intraocular Lens" by Xi'an Yandale Medical Technology Co., Ltd. [1][8] - As of now, a total of 373 innovative medical devices have been registered in China [1]. Group 2: Company Profiles - Aibono Medical Technology Co., Ltd. is an innovative ophthalmic medical device manufacturer listed on the Sci-Tech Innovation Board, focusing on cataract surgery, myopia control, and vision care solutions. The company reported a total revenue of 787 million yuan (approximately $114 million) with a year-on-year growth of 14.72% and a net profit of 213 million yuan (approximately $31 million) with a growth of 2.53% in the first half of 2025 [6]. - Shenyang Pengyue Technology Co., Ltd., established in 2020, specializes in digital intelligent precision medical fields and has developed a cardiac cryoablation system with independent intellectual property rights [10]. - Xi'an Yandale Medical Technology Co., Ltd. focuses on intraocular lenses for cataract treatment and is led by a team of experts, including members from the American Academy of Engineering [18]. Group 3: Product Details - The "Extended Depth of Focus Intraocular Lens" is designed for vision correction after cataract surgery, featuring a one-piece, foldable design made from a combination of ethyl acrylate and methyl methacrylate [5]. - The "Cardiac Cryoablation Device" is used for treating persistent atrial fibrillation in adult patients, utilizing argon gas for rapid cooling of myocardial cells [9]. - The "Cross-linked Polyisobutylene Aspheric Intraocular Lens" is notable for its high refractive index and is designed for implantation through a small incision, providing an improved visual experience for cataract patients [15].