Tandem Mobi获FDA许可成为全球首个无管自动胰岛素输注系统：输注套装最长可佩戴7天
总部位于加州 San Diego 的胰岛素输注与糖尿病技术公司 Tandem Diabetes Care（纳斯达克代码：TNDM）2026年11月13日宣布，美国食品药品监督管理局（FDA）已许可其 Tandem Mobi 胰岛素泵配合新型无管药液仓与输注套装使用，成为全球首个、也是目前唯一可无管佩戴的自动胰岛素输注（AID）系统。公司向美国证券交易委员会提交的文件显示，FDA 于11月12日授予这项许可。
新的无管药液仓与输注套装可把现有 Tandem Mobi 泵改装成无管佩戴装置：输注套装获准最长佩戴 7 天，药液仓获准使用 3 天，换贴频率降低。泵体沿用 Control-IQ+ 先进混合闭环技术，可依据连续血糖监测读数预测 30 分钟后的血糖水平并自动调整胰岛素输注，AutoBolus 功能可协助预防高血糖。经此许可，Tandem Mobi 成为唯一同时提供有管与无管两种输注方式的胰岛素泵，用户可按自身需要选择佩戴方式。
Tandem Diabetes Care 总裁兼首席执行官 John Sheridan 表示，Tandem Mobi 在设计之初就预留了多种佩戴方式的可能，如今新增最长 7 天佩戴的无管选项；无管药液仓与输注套装获许可，为糖尿病患者体验 Control-IQ+ 技术的好处打开了更多方式。
上市安排方面，无管药液仓与输注套装计划于 2027 年上半年在美国全面上市。在保修期内的现有 Tandem Mobi 泵无需更换，本身已兼容新套装与药液仓，公司将在产品可供时联系符合资格的客户。无管输注套装与药液仓将仅通过药房渠道供应、面向享有药房福利的客户；公司估算，目前美国约 50% 的已投保人群可经药房渠道获得 Tandem Mobi 相关保障，预计覆盖面在上市前及 2027 年内继续扩大。
Tandem Mobi 号称全球最小的胰岛素泵，配 200 单位药液仓，支持感应充电、防水（IP28）与手机应用控制，可暂时断开以便淋浴、泡浴或进行接触性运动。（来源：Tandem Diabetes Care）
Tandem Mobi Cleared by FDA as the World's First Tubeless Automated Insulin Delivery System, With Infusion Sets Worn Up to Seven Days
Tandem Diabetes Care, Inc. (Nasdaq: TNDM), the San Diego, California-based insulin delivery and diabetes technology company, announced on November 13, 2026, that the U.S. Food and Drug Administration (FDA) has cleared its Tandem Mobi insulin pump for use with a new tubeless cartridge and infusion set, making it the world's first and only tubeless automated insulin delivery (AID) system. A filing with the U.S. Securities and Exchange Commission shows the FDA granted the clearance on November 12.
The new tubeless cartridge and infusion set convert the current Tandem Mobi pump into a tubeless device: the infusion set is cleared for up to seven days of wear and the cartridge for three days of use, meaning less frequent site changes. The pump keeps the Control-IQ+ advanced hybrid closed-loop technology, which uses continuous glucose monitor readings to predict glucose levels 30 minutes ahead and automatically adjust insulin delivery, with AutoBolus to help prevent hyperglycemia. With this clearance, Tandem Mobi is now the only pump cleared for both tubeless and tubed infusion options, letting users choose the wear option that best meets their needs.
“The Tandem Mobi insulin pump was originally designed to make different wear options possible, which now includes a tubeless option with up to 7 days of wear,” said John Sheridan, president and chief executive officer. “This clearance of the Tandem Mobi tubeless cartridge and infusion set creates even more possibilities for people living with diabetes, expanding the number of ways to experience the proven benefits of our Control-IQ+ AID technology.”
Full commercial launch of the tubeless cartridge and infusion set in the United States is planned for the first half of 2027. Customers with an in-warranty Tandem Mobi will not need a new pump, as existing pumps are already compatible; Tandem will contact eligible customers when the sets and cartridges become available. The tubeless infusion sets and cartridges will be available exclusively through the pharmacy for customers with pharmacy benefits; the company estimates pharmacy coverage is currently available for approximately 50% of insured lives in the United States, with continued expansion expected ahead of launch and throughout 2027.
Tandem Mobi is billed as the world's smallest insulin pump, with a 200-unit cartridge, inductive charging, water resistance (IP28) and smartphone app control, and it can be temporarily disconnected for showering, hot tubs or contact sports. (Source: Tandem Diabetes Care, Inc)
来源：Tandem Diabetes Care
发布：GSM·美国（发布链接）
图片来源：图：Tandem Diabetes Care 的自动胰岛素输注系统产品图，右侧小泵为 Tandem Mobi，旁置硬币示其体积。图片来源：Tandem Diabetes Care 官网企业官方图。 / Photo: Tandem Diabetes Care automated insulin delivery systems; the small pump at right is Tandem Mobi, shown next to a quarter for scale. Image: Tandem Diabetes Care official product image.
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