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More than 200 people with diabetes have been injured when their insulin pumps shut down unexpectedly due to a problem with a connected mobile app, the US Food and Drug Administration said Wednesday.
The FDA has issued a statement following the Class I recall for an IOS app used in conjunction with insulin pumps after 224 injuries were reported.
The green light was turned on for the company's t:slim X2 automated insulin delivery (AID) pump to be used to deliver Eli Lilly's (NYSE: LLY) Lyumjev -- an ultra-rapid acting insulin product.
In November 2011, the company received FDA clearance to market the t:slim Insulin Pump, the first ever touch-screen insulin pump. [10] In February 2013, the company received FDA clearance to market the t:connect Diabetes Management Application, a Mac and PC-compatible data management application that provides t:slim Pump users and their healthcare providers a way to display data from the pump ...
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 ...
Late Thursday, Tandem Diabetes Care Inc (NASDAQ: TNDM ) announced FDA approval of its t:slim X2 insulin pump with Basal-IQ for Type 1 diabetes patients, which is planned for an August launch. With ...
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