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    Home»News»MiniMed submits new patch pump for FDA clearance
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    MiniMed submits new patch pump for FDA clearance

    HealthradarBy Healthradar2. September 2026Keine Kommentare3 Mins Read
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    MiniMed submits new patch pump for FDA clearance
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    By the numbers

     

    Q1 27 revenue: $843 million

    17% increase year over year

    Following the debut of its smallest insulin pump, diabetes tech firm MiniMed is planning more device launches next year. The company, which spun out of Medtronic earlier this year, said Tuesday that it has filed a Food and Drug Administration submission for its first patch pump, with a planned launch next summer.

    CEO Que Dallara told investors on an earnings call that the company is preparing for a commercial launch of the patch pump, called MiniMed Fit. Currently, Insulet leads the U.S. market for insulin patch pumps, but competitors including MiniMed and Tandem Diabetes Care have been working on their own versions of the technology.

    Dallara said that Fit would have a 300-unit insulin reservoir, larger than other devices on the market today, and would accommodate up to seven days of wear time. This could better support people with Type 2 diabetes, who may require more insulin and benefit from fewer device change-outs, the CEO said.

    MiniMed also completed enrollment of a pivotal trial for a fully closed loop algorithm, which would calculate the amount of insulin a person needs throughout the day, even if they don’t announce meals or count carbohydrates. MiniMed also plans to launch the feature later next year. 

    Finally, MiniMed is working on a new glucose sensor with a longer wear time. The company received an investigational device exemption that would allow it to start a pivotal trial this fall. MiniMed has not yet shared what features the sensor will have or how long of a wear time it is targeting. Its current sensor, Simplera Sync, has a six-day wear time, while competing devices have wear times ranging from 10 to 15 days.

    MiniMed partnered with Abbott in 2024, with Abbott agreeing to offer a version of its glucose sensors that works exclusively with MiniMed’s devices. Dallara said that continuous glucose monitors have “been our Achilles’ heel for a very long time,” and that the new sensor has helped drive insulin pump growth.

    New guidance

    MiniMed raised its sales forecast by half a percent, now expecting organic revenue growth of 10.5% for its 2027 fiscal year, which ends in April. The U.S. launch of a smaller tubed insulin pump, called MiniMed Flex, and increasing adoption of the company’s glucose sensors globally led the company to increase its guidance, CFO Chad Spooner said on the earnings call.

    In the U.S., the number of pumps sold increased by 20% year over year, driven by the launch of MiniMed Flex, which started shipping in late June, Dallara said. 

    The device has received Europe’s CE mark, MiniMed announced Tuesday, with plans for a commercial launch in November.

    “What excites me the most is that all these pieces are starting to come together,” Dallara said.



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