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Medtronic plc (MDT) Announces FDA Approval for SmartGuard Algorithm as Automated Glycemic Controller
Yahoo Finance· 2025-09-10 16:53
Medtronic plc (NYSE:MDT) is one of the 14 Tech Stocks to Sell Now According to Ken Fisher. Medtronic plc (MDT) Announces FDA Approval for SmartGuard Algorithm as Automated Glycemic Controller On September 2, 2025, Medtronic plc (NYSE:MDT) announced that the FDA cleared its SmartGuard algorithm as an interoperable automated glycemic controller, allowing its integration with Abbott’s Instinct sensor for type 1 diabetes. At the same time, the company’s MiniMed 780G system also received approval for adults w ...
Medtronic advances Abbott CGM partnership with FDA submission of interoperable insulin pump
Prnewswire· 2025-04-24 21:00
核心观点 - 美敦力已向FDA提交510(k)申请 寻求其MiniMed™ 780G胰岛素泵与SmartGuard™算法作为互操作自动化血糖控制器的许可 若获批将实现与雅培最先进CGM平台的系统集成[1][2][3] 技术进展 - 提交两项510(k)申请:MiniMed™ 780G泵作为替代控制器启用(ACE)胰岛素泵 以及SmartGuard™算法作为互操作自动化血糖控制器(iAGC)[2] - 系统集成基于雅培最先进CGM平台 雅培将向美敦力独家供应CGM传感器 用于美敦力智能给药设备和软件[3] 商业合作 - 美敦力与雅培自2024年8月起合作开发集成系统 雅培CGM将专用于美敦力自动胰岛素输送和智能多次每日注射系统[3] - 包含雅培CGM的系统将由美敦力独家销售[3] 公司背景 - 美敦力糖尿病业务致力于通过先进技术减轻糖尿病负担 拥有40余年创新历史 专注于下一代CGM传感器、智能给药系统及数据科学与AI应用[5] - 美敦力是全球医疗技术领导者 业务覆盖150多个国家 拥有超过95,000名员工 其技术和疗法治疗70种健康状况 包括心脏设备、手术机器人、胰岛素泵等[6]