Medtronic has earned U.S. Food and Drug Administration (FDA) approval for its Simplera continuous glucose monitor (CGM).

美敦力的Simplera连续血糖监测仪（CGM）已获得美国食品和药物管理局（FDA）的批准。

Simplera is the company’s first disposable, all-in-one CGM. It’s half the size of prior Medtronic CGMs. Its design simplifies insertion and wear, according to Medtronic, removing the need for overtape. The Simplera CGM earned CE mark approval in September 2023.

Simplera是该公司第一款一次性多功能CGM。它的大小是之前美敦力CGM的一半。美敦力表示，它的设计简化了插入和磨损，消除了过度成形的需要。Simplera CGM于2023年9月获得CE标志批准。

The CGM is designed to be used as part of a Smart MDI system with the InPen smart insulin pen and Simplera Sync sensor. This is integrated with the MiniMed 780G system.

CGM被设计为智能MDI系统的一部分，带有InPen智能胰岛素笔和Simplera同步传感器。它与MiniMed 780G系统集成。

Medtronic said the FDA approval paves the way for future submission of the updated InPen smart insulin app, facilitating integration with the Simplera CGM. Once the FDA nod is obtained, the company plans to start limited market release in the U.S., beginning with current standalone CGM and and InPen customers..

美敦力表示，FDA的批准为将来提交更新的InPen智能胰岛素应用程序铺平了道路，促进了与Simplera CGM的集成。一旦获得FDA的批准，该公司计划在美国开始有限的市场发布，从目前的独立CGM和InPen客户开始。。

The Simplera Sync sensor is under FDA review and received EU approval in January.

Simplera Sync传感器正在接受FDA审查，并于1月份获得欧盟批准。

Partnership to complement future Medtronic CGM offerings

合作伙伴关系，以补充未来美敦力CGM产品

Medtronic also revealed a global partnership with Abbott. The duo plans to collaborate on an integrated CGM based on Abbott’s most advanced CGM platform.

美敦力还透露了与雅培的全球合作关系。这两人计划在雅培最先进的CGM平台上合作开发一个综合CGM。

Abbott will supply Medtronic with a CGM that will work exclusively with Medtronic smart dosing devices and software for insulin delivery and Smart MDI systems. Medtronic will exclusively sell these systems, which includes the Abbott-based CGM.

雅培将为美敦力提供CGM，该CGM将专门用于美敦力智能给药设备和胰岛素输送软件以及智能MDI系统。美敦力将独家销售这些系统，其中包括基于雅培的CGM。

Financial terms and timing of commercial release were not disclosed.

财务条款和商业发行时间未披露。

'Our partnership with Abbott allows us to expand access to our advanced automated insulin delivery and Smart MDI systems that deliver best-in-class outcomes with the most widely used CGM in the world. We look forward to offering our Simplera platform alongside this integrated CGM to bring more choice to people living with diabetes within one seamless Medtronic experience,' said Que Dallara, executive VP and president, Medtronic Diabetes..

“我们与雅培的合作伙伴关系使我们能够扩大对先进的自动胰岛素输送和智能MDI系统的访问，这些系统可以通过世界上使用最广泛的CGM提供一流的结果。美敦力糖尿病公司执行副总裁兼总裁奎·达拉拉（QueDallara）说：“我们期待着与此集成的CGM一起提供Simplera平台，在一次无缝的美敦力体验中为糖尿病患者带来更多选择。”。。

'This partnership pairs two global leaders in glucose sensing technology and insulin delivery,' added Jared Watkin, executive VP of Abbott's diabetes care business. 'Abbott's CGM technology has set the standard for accurate, accessible, easy-to-use and reliable continuous glucose monitoring. Connecting this CGM built for Medtronic's advanced insulin delivery systems and algorithms makes it easier for people to spend less time thinking about their diabetes and more time living.' .

雅培（Abbott）糖尿病护理业务执行副总裁贾里德·沃特金（JaredWatkin）补充说，这一合作伙伴关系将两个全球领先的葡萄糖传感技术和胰岛素输送领域的公司配对雅培（Abbott）的CGM技术为准确、可访问、易于使用和可靠的连续血糖监测设定了标准。将为美敦力（Medtronic）先进的胰岛素输送系统和算法构建的CGM连接起来，可以让人们更轻松地花更少的时间思考糖尿病，延长生活时间。”。