Tandem Diabetes Gets FDA Nod For T:slim X2 Insulin Pump
Zacks Investment Research | Dec 15, 2019 11:22PM ET
Tandem Diabetes Care, Inc. (NASDAQ:TNDM) recently announced the FDA clearance for the t:slim X2 insulin pump with Control-IQ advanced hybrid-closed loop technology. This follows the last-month’s receipt of the Canadian nod for the same pump with Basal-IQ technology.
The latest regulatory clearance is expected to accelerate Tandem Diabetes’ pump shipments within the United States and expand its customer base.
More About t:slim X2 With Control-IQ
The t:slim X2 insulin pump with Control-IQ technology uses Dexcom G6 CGM sensor values to forecast glucose levels and adjust insulin delivery to ensure the prevention of erratic highs and lows.
Control-IQ technology for the t:slim X2 insulin pump is the first automated insulin dosing software in a new interoperable automated glycemic controller category. This feature automatically adjusts insulin delivery to the patient by connecting to an alternate controller-enabled insulin pump (ACE pump) and integrated continuous glucose monitor (iCGM).
Per Tandem Diabetes, this is the third category classified by the FDA for the interoperability of devices as a complete automated insulin dosing (AID) system.
Users of the existing t:slim X2 pumps can add this feature free of cost to their device via a remote software update (available by the end of Jan 2020). The new pumps with Control-IQ technology will begin shipping to customers in the same time frame.
Meanwhile, the company will continue offering the t:slim X2 pump with Basal-IQ predictive low glucose suspend technology as another treatment option.
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