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t:slim X2 Insulin Pump to Bolus Using the t:connect Mobile App Receives FDA Clearance

First Smartphone App FDA cleared for Insulin Delivery on Both iOS and Android Operating Systems

Tandem Diabetes Care, Inc. (NASDAQ:TNDM), a leading insulin delivery and diabetes technology company, today announced U.S. Food and Drug Administration (FDA) clearance of bolus insulin dosing on the t:slim X2 insulin pump using the t:connect mobile app.

This represents the first-ever FDA-cleared smartphone application capable of initiating insulin delivery on both iOS and Android operating systems. The updated t:connect mobile app is designed to offer t:slim X2 insulin pump users the ability to program and cancel bolus insulin requests through the convenience of their compatible smartphone.

“This FDA clearance further validates our commitment to innovation and the diabetes community by providing one of the most requested feature enhancements,” said John Sheridan, president and CEO of Tandem Diabetes Care. “With the improvements in diabetes management provided by Tandem’s Control-IQ technology, giving a meal bolus is now the most common reason a person interacts with their pump, and the ability to do so using a smartphone app offers a convenient and discrete solution.”

When released, this new feature will be offered in the United States for no additional cost to new t:slim X2 insulin pump customers and to in-warranty customers through a remote software update for the t:slim X2 insulin pump and the updated t:connect mobile app. The Company intends to roll out the mobile bolus feature update throughout the spring in a series of limited launch groups, followed by an expanded launch later this summer. Limited launch participants have already been selected.

The t:connect mobile app is a secure, user-friendly mobile application that, when paired with a t:slim X2 insulin pump, discreetly displays the user’s pump information on their personal smartphone. In addition to the newly cleared bolus feature, the mobile app displays the last 24 hours of glucose trends, pump status changes, and insulin therapy data, including basal and bolus deliveries and suspensions of insulin delivery. The app also displays pump alerts and alarms, and it securely uploads data into the cloud-based t:connect web application wirelessly. Importantly, the t:slim X2 insulin pump functions independently from the t:connect mobile app, therefore a user always retains the freedom to view pump therapy data, program requests and cancel bolus insulin requests from their pump.

The t:connect mobile app is compatible with select versions of both iOS and Android operating systems in the United States. To ensure compatibility, Tandem verifies each combination of device and operating system works as intended to program and cancel a bolus from your smartphone. This means that not every smartphone will be able to use the bolus feature within the t:connect mobile app. More here.

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Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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