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     641  0 Kommentare Tandem Mobi, World’s Smallest Durable Insulin Delivery System, Receives FDA Clearance - Seite 2

    About Control-IQ Advanced Hybrid Closed-Loop Technology

    The Tandem Mobi will be offered with Control-IQ technology, a hybrid-closed loop algorithm for use by people with type 1 diabetes age 6 and up. Control-IQ technology uses compatible continuous glucose monitoring (CGM) sensor values to predict glucose levels 30 minutes ahead and adjust insulin delivery every 5 minutes to help prevent highs and lows, while still allowing the user to manually bolus for meals. It can also deliver automatic correction boluses (up to one an hour) to help prevent hyperglycemia.2 Real-world data shows immediate and sustained glycemic improvements — including more time in range and better sleep.3 Results from major studies of Control-IQ technology were published by the New England Journal of Medicine in October 2019, August 2020, and March 2023.

    About Tandem Diabetes Care, Inc.

    Tandem Diabetes Care, Inc., a global insulin delivery and diabetes technology company based in San Diego, California, creates new possibilities for people living with diabetes, their loved ones, and healthcare providers through a positively different experience. The company’s human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Tandem manufactures and sells the t:slim X2 insulin pump with Control-IQ technology. For more information, visit tandemdiabetes.com.

    Follow Tandem Diabetes Care on Twitter @tandemdiabetes; use #tslimX2 and #TandemDiabetes.
    Follow Tandem Diabetes Care on Facebook at facebook.com/TandemDiabetes.
    Follow Tandem Diabetes Care on LinkedIn at linkedin.com/company/tandemdiabetes.

    Forward-looking Statements

    This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements relate to, among other things, the anticipated timing for the limited release and subsequent commercial launch of the Tandem Mobi system. These forward-looking statements are subject to numerous risks and uncertainties, including risks associated with the commercial launch of a new product, as well as manufacturing risks and risks related to adequate reimbursement coverage. These and other risks are identified and described in greater detail under the “Risk Factors” heading of our most recent Annual Report on Form 10-K. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Actual results could differ materially from those anticipated or projected in the forward-looking statements. Tandem undertakes no obligation to update or review any forward-looking statement in this press release because of new information, future events, or other factors.

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    Tandem Mobi, World’s Smallest Durable Insulin Delivery System, Receives FDA Clearance - Seite 2 Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery and diabetes technology company, today announced U.S. Food and Drug Administration (FDA) clearance for the Tandem Mobi insulin pump for people with diabetes age 6 and up, …