FDA Grants Marketing Authorization to Tandem Diabetes Care for First Interoperable Insulin Pump
FDA is allowing the marketing of a new type of insulin pump that helps patients who want more control over managing their diabetes. The Tandem Diabetes Care t:Slim X2 insulin pump is the first interoperable pump, also known as an alternate controller enabled (ACE) infusion pump, that can be used with different components that comprise diabetes therapy systems. Allowing patients to customize their diabetes therapy, the pump is compatible with devices such as automated insulin dosing systems and continuous glucose monitors.
The t:Slim X2 pump delivers insulin under the skin and can either operate on its own to infuse insulin or be digitally connected to other diabetes management devices to communicate and receive drug dosing commands.
About 10% of Americans have diabetes, and being able to customize their own diabetes management devices is important, said FDA Commissioner Scott Gottlieb, M.D. in an agency news release. He added that this particular marketing authorization “opens the door for developers of future connected diabetes devices to get other safe and effective products to patients more efficiently. Because the FDA’s action creates a new regulatory classification, future ACE insulin pumps will be able to go through the more efficient 510(k) review process, helping to advance this innovative technology.”
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