Tandem Diabetes Care, Inc. (NASDAQ:TNDM) Files An 8-K Other EventsItem 9.01 Other Events
On August 25, 2017, the U.S. Food and Drug Administration (FDA) approved our pre-market application (PMA) for the t:slim X2 Insulin Pump with Dexcom G5® Mobile continuous glucose monitoring (CGM) integration.The software featured on this newly approved pump will also be offered to current t:slim X2 Pump users at no cost via remote software update, allowing them to add CGM integration to their existing t:slim X2 Pumps from home using a personal computer. The t:slim X2 Pump with Dexcom G5 Mobile CGM integration 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 August 28, 2017 we issued a press release announcing the FDA approval and commercial launch of the t:slim X2 Insulin Pump with Dexcom G5 Mobile integration. 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.
|
Number |
Description |
|
99.1 |
Press release of Tandem Diabetes Care, Inc. dated August 28, 2017. |
TANDEM DIABETES CARE INC ExhibitEX-99.1 2 tndm-ex991_6.htm EX-99.1 tndm-ex991_6.htm Ex. 99.1 Media Contact: Steve Sabicer 714-907-6264 ssabicer@thesabicergroup.com Investor Contact: Susan Morrison 858-366-6900 x7005 smorrison@tandemdiabetes.com FOR IMMEDIATE RELEASE Tandem Diabetes Care Announces FDA Approval and Launch of t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM Integration ‒ Software Update Available for Current t:slim X2 Pump Users Via Personal Computer ‒ San Diego,…To view the full exhibit click here
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.