Medtronic plc announced FDA approval for the Simplera Sync sensor for use with the MiniMed 780G system

美敦力公司宣布FDA批准Simplera Sync传感器与MiniMed 780G系统配合使用。

With this approval, the MiniMed 780G system now offers more flexibility for users of the company's most advanced insulin delivery system featuring Meal Detection technology with both the Guardian 4 sensor and Simplera Sync sensor.

通过此次批准，MiniMed 780G系统现在为其最先进的胰岛素输送系统提供了更大的灵活性，该系统具有餐食检测技术，并同时支持Guardian 4传感器和Simplera Sync传感器。

The Simplera Sync is a disposable, all-in-one sensor that requires no fingersticks with SmartGuard or overtape and features a simple, two-step insertion process. It is the company's newest addition to its CGM portfolio, which expands options and provides greater flexibility for users.

Simplera Sync 是一款一次性、一体化传感器，使用 SmartGuard 或胶带固定时无需指尖采血，并具有简单两步的插入过程。这是该公司 CGM 产品组合中的最新产品，为用户提供了更多选择和更大的灵活性。

The MiniMed 780G system's adaptive algorithm automatically anticipates, adjusts, and corrects glucose levels every 5 minutes, 24/7 – working around the clock so users can focus on what matters. It's the only system featuring Meal Detection technology, which detects rising sugar levels and delivers more insulin as needed to help users keep glucose levels in range more often – even when users occasionally forget to dose insulin for snacks or meals or underestimate their carbs.

MiniMed 780G系统的自适应算法全天候每5分钟自动预测、调整和纠正血糖水平，持续工作，让用户专注于重要事项。它是唯一一款配备餐食检测技术的系统，该技术能够检测血糖水平的上升，并根据需要提供更多的胰岛素，帮助用户更频繁地保持血糖在目标范围内——即使用户偶尔忘记为零食或餐食注射胰岛素或低估了碳水化合物摄入量。

The system uses a 'treat to target' approach and flexible glucose targets as low as 100 mg/dL, which, combined with its adaptive algorithm allows it to more closely mirror the glucose levels of someone not living with diabetes. Real-world data of the system shows global users consistently achieve time in range above international targets of 70% when using optimal settings (active insulin time of two hours and 100 mg/dL target glucose).

该系统采用“目标治疗”方法，并使用低至100 mg/dL的灵活血糖目标，结合其自适应算法，能够更接近非糖尿病患者的血糖水平。该系统的现实世界数据显示，当使用最佳设置（活性胰岛素时间为两小时，目标血糖为100 mg/dL）时，全球用户的时间范围始终高于国际目标的70%。

It is also the only system that works with the world's only infusion set that lasts up to 7 days so that users only have to change their infusion set once per week and can experience 96% fewer injections compared to multiple daily injections..

它也是唯一一个与世界上唯一的输液装置配合使用的系统，该装置可以持续使用长达7天，因此用户每周只需更换一次输液装置，并且与每天多次注射相比，注射次数可减少96%。

'We're committed to driving innovation that makes life easier for those living with diabetes so they can forget about their diabetes as much as possible throughout the day,' said Que Dallara, EVP and president of Medtronic Diabetes. 'Our MiniMed 780G system delivers advanced diabetes technology for so many around the world, and we're excited to continue evolving this experience with expanded CGM options —including our Simplera Sync sensor, which we look forward to bringing to people living with diabetes in the U.S.'.

“我们致力于推动创新，让糖尿病患者的生活更轻松，使他们可以在一天中尽可能多地忘记自己的病情，”美敦力糖尿病业务的执行副总裁兼总裁Que Dallara表示。“我们的MiniMed 780G系统为世界各地的许多人提供了先进的糖尿病技术，我们很高兴通过扩展的CGM选项继续优化这一体验——包括我们期待为美国糖尿病患者带来的Simplera Sync传感器。”

A limited launch of the Simplera Sync sensor will begin in the U.S. in the fall of 2025. Today, the MiniMed 780G system can be used with the Guardian 4 sensor.

Simplera Sync传感器的有限发布将于2025年秋季在美国开始。目前，MiniMed 780G系统可以与Guardian 4传感器一起使用。

The FDA approval of Medtronic's Simplera Sync sensor for use with the MiniMed 780G insulin pump system does not cancel or negate the prior recall of the MiniMed 600 and 700 series pumps, including the 780G model. The recall, issued in 2024, was due to a critical battery issue where physical impacts could damage internal electrical components, leading to shortened battery life and potential cessation of insulin delivery without adequate warning .​ While the FDA approval enhances the flexibility and options for users of the MiniMed 780G system, it does not address the battery issue that led to the recall.

FDA批准美敦力公司Simplera Sync传感器与MiniMed 780G胰岛素泵系统配合使用，并未取消或否定之前对MiniMed 600和700系列泵（包括780G型号）的召回。2024年发布的召回是因为一个严重的电池问题，物理冲击可能损坏内部电气元件，导致电池寿命缩短，并可能在没有足够警告的情况下停止胰岛素输送。尽管FDA的批准增强了MiniMed 780G系统用户的灵活性和选择，但并未解决导致召回的电池问题。

Users should continue to follow Medtronic's guidance regarding the recall, including monitoring battery alerts, carrying spare batteries, and contacting Medtronic if they notice a significant decrease in battery life ..

用户应继续遵循美敦力关于召回的指导，包括监测电池警报、携带备用电池，以及在发现电池寿命显著缩短时联系美敦力。

Condition:

条件：

Diabetes Type 1

1型糖尿病

Type:

类型：

drug

药物