Tandem Diabetes Care, Inc. (NASDAQ:TNDM) Files An 8-K Other Events
Item 9.01 Other Events

On June 21, 2018, the U.S. Food and Drug Administration (FDA) approved our pre-market application (PMA) for the t:slim X2™ Insulin Pump with Basal-IQ™ technology, a predictive low glucose suspend (PLGS) feature designed to help reduce the frequency and duration of low glucose events (hypoglycemia).The t:slim X2 with Basal-IQ technology is also the first insulin pump designated as compatible with integrated continuous glucose monitoring (iCGM) devices, such as the Dexcom G6 continuous glucose monitoring (CGM) system. The software featured on this newly approved pump will be offered to current in-warranty t:slim X2 Pump users in the United States free of charge via remote software update. The t:slim X2 Pump with Basal-IQ technology is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin for individuals 6 years of age and greater.

On June 21, 2018 we issued a press release announcing the FDA approval and planned commercial launch of the t:slim X2 Insulin Pump with Basal-IQ technology and related software updates for eligible t:slim X2 users. The accompanying press release is attached hereto as Exhibit 99.1and is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

TANDEM DIABETES CARE INC Exhibit
EX-99.1 2 tndm-ex991_6.htm EX-99.1 PRESS RELEASE APPROVAL OF BASAL IQ tndm-ex991_6.htm Exhibit 99.1         FOR IMMEDIATE RELEASE   Tandem Diabetes Care Announces FDA Approval of t:slim X2 Insulin Pump with Basal-IQ Technology New Predictive Low Glucose Suspend Feature to Launch with Dexcom G6 CGM System Integration San Diego,…
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About Tandem Diabetes Care, Inc. (NASDAQ:TNDM)

Tandem Diabetes Care, Inc. is a medical device company. The Company is engaged in designing, developing and commercializing products for people with insulin-dependent diabetes. The Company manufactures and sells three insulin pump products, which include t:slim Insulin Delivery System (t:slim), t:flex Insulin Delivery System (t:flex) and t:slim G4 Insulin Delivery System (t:slim G4). Its technology platform features Micro-Delivery Technology, a miniaturized pumping mechanism, which draws insulin from a flexible bag within the pump’s cartridge rather than relying on a syringe and plunger mechanism. It also features a software, which is a vivid color touch screen and a micro- universal serial bus (USB) connection that supports both a rechargeable battery and uploads to t:connect Diabetes Management Application (t:connect), its custom cloud-based data management application that provides display therapy management data from the pump and supported blood glucose meters.