EN
登录

美敦力向FDA提交可互操作的胰岛素泵,推进与雅培CGM的合作

Medtronic advances Abbott CGM partnership with FDA submission of interoperable insulin pump

美敦力 等信源发布 2025-04-24 21:07

可切换为仅中文


/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced it has submitted 510(k) applications to the U.S. Food and Drug Administration (FDA) seeking clearance for an interoperable pump. FDA clearance of this pump would pave the way for system integration with a continuous glucose monitoring (CGM) sensor based on Abbott's most advanced CGM platform..

/ -- 全球医疗技术领导者美敦力公司(纽约证券交易所代码:MDT)今天宣布,已向美国食品和药物管理局(FDA)提交了510(k)申请,寻求一款可互操作泵的批准。该泵一旦获得FDA批准,将为与基于雅培最先进的连续血糖监测(CGM)平台的传感器进行系统集成铺平道路。

The submissions included a 510(k) application for its MiniMed™ 780G pump as an alternate controller enabled (ACE) insulin pump and a separate 510(k) application for its SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC).

提交的文件包括其MiniMed™ 780G泵作为替代控制器启用(ACE)胰岛素泵的510(k)申请,以及其SmartGuard™算法作为互操作自动血糖控制器(iAGC)的另一份510(k)申请。

'We understand how meaningful these advancements are, and we're working with urgency to bring enhanced CGM options to our customers,' said Que Dallara, EVP & president, Medtronic Diabetes. 'This collaboration with Abbott marks an important step forward in providing innovative solutions and more choice for our customers.'.

“我们理解这些进步有多么重要,我们正在加紧努力,为我们的客户带来更先进的CGM选择,”美敦力糖尿病业务的执行副总裁兼总裁Que Dallara表示。“与雅培的合作标志着我们在提供创新解决方案和为客户带来更多选择方面迈出了重要的一步。”

This milestone follows the

这一里程碑遵循

announcement last August

去年八月的公告

that the companies will collaborate on an integrated system based on Abbott's most advanced CGM platform. Abbott will supply Medtronic with a CGM that will work exclusively with Medtronic smart dosing devices and software across both automated insulin delivery and smart multiple daily injections systems.

Abbott的公司将合作开发基于其最先进的CGM平台的集成系统。Abbott将向Medtronic提供一款CGM,该设备将仅与Medtronic的智能给药设备和软件配合使用,涵盖自动胰岛素输送和智能多次每日注射系统。

These systems, including the Abbott CGM, will be sold exclusively by Medtronic..

这些系统,包括雅培的CGM,将由美敦力独家销售。

More details will be shared when FDA clearance is secured.

更多细节将在获得FDA批准后分享。

About the Diabetes Business at Medtronic

关于美敦力的糖尿病业务

Medtronic Diabetes is on a mission to alleviate the burden of diabetes by empowering individuals to live life on their terms, with the most advanced diabetes technology and always-on support when and how they need it. We've pioneered first-of-its-kind innovations for over 40 years and are committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and AI while always putting the customer experience at the forefront..

美敦力糖尿病事业部致力于通过最先进的糖尿病技术和随时随地的支持,帮助患者减轻糖尿病的负担,让他们按照自己的方式生活。四十多年来,我们一直引领着开创性的创新,并通过下一代传感器(CGM)、智能给药系统以及数据科学和人工智能的力量,不断设计糖尿病管理的未来,同时始终将用户体验放在首位。

About Medtronic

美敦力公司简介

, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries.

是全球领先的医疗技术公司,勇敢地应对人类面临的最严峻的健康问题,通过不断寻找和发现解决方案。我们的使命——减轻痛苦、恢复健康、延长生命——将遍布150多个国家的95,000多名充满热情的员工团结在一起。

Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day.

我们的技术和疗法治疗70种健康状况,包括心脏设备、手术机器人、胰岛素泵、手术工具、患者监测系统等。凭借我们多样化的知识、无尽的好奇心和帮助所有需要帮助的人的愿望,我们提供了创新的技术,每秒、每小时、每一天都在改变两个人的生活。

Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit .

随着我们赋能以洞察力为导向的护理、以人为本的体验以及为我们的世界带来更好的结果,期待我们做得更多。在我们所做的一切中,我们正在创造非凡。欲了解有关美敦力(纽约证券交易所代码:MDT)的更多信息,请访问。