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Dexcom entered into a partnership in 2015 with Google Life Sciences (which subsequently became Verily) to develop the Dexcom G7 [21] [22] [23]; Dexcom entered a non-exclusive agreement with Tandem Diabetes Care, Inc. in 2015 to allow the integration of its new G5 and G6 continuous glucose monitoring systems into Tandem's insulin pumps.
The FDA approved a tool to update the software on Tandem's pumps in July 2016. The Tandem Device Updater would be used to deliver all software updates to Tandem's pumps moving forward and that the first use of the new tool will be to update t:slim pumps which were shipped prior to April 2015 with a new version of the firmware which speeds the ...
The Tandem Diabetes Care t:Slim X2 was approved by the U.S. Food and Drug Administration in 2019 and is the first insulin pump to be designated as an alternate controller enabled (ACE) insulin pump. ACE insulin pumps allow users to integrate continuous glucose monitors, automated insulin dosing (AID) systems, and other diabetes management ...
Tandem Diabetes' (TNDM) t:slim X2 Insulin Pump with Control-IQ Advanced Hybrid Closed-Loop Technology cleared for use in Canada post the receipt of Health Canada approval.
A glitch in a version of Tandem Diabetes Care's Apple iOS app that is used with certain insulin pumps has led to over 200 injuries, prompting the FDA to issue a recall.
Tandem Diabetes' (TNDM) insulin pump seems to be a strategic fit and well-timed from its massive uptake by the diabetic patients in Canada. Tandem Diabetes Signs as an Insulin Pump Vendor in ...
The letters were intended to let manufacturers know how much work is needed on their applications. [1] Non-approval letters were rejections of a drug's application. [2] Approvable and non-approvable letters were covered under Title 21 of the Code of Federal Regulations, section 314.110. [3]
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