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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.
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 ...
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.
Insulin pumps, cartridges, and infusion sets may be far more expensive than syringes used for insulin injection with several insulin pumps costing more than $6,000; necessary supplies can cost over $300. [3] Another disadvantage of insulin pump use is a higher risk of developing diabetic ketoacidosis if the pump malfunctions. [3]
The medical device maker announced Thursday the FDA approved its t:slim X2 Insulin pump with Basal-IQ technology. Tandem Diabetes expects to make the t:slim X2 pump with Basal-IQ technology ...
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