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Medical Devices / Submissions and Approvals

FDA Clears Insulin Pump to Allow Patients to Customize Treatment

Feb. 19, 2019
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The FDA cleared the marketing of Tandem Diabetes Care’s t:Slim X2 insulin pump, a new type of interoperable pump that allows patients to control their diabetes management.

The alternate controller enabled (ACE) infusion pump can be used with compatible medical devices, including automated insulin dosing (AID) systems, continuous glucose monitors (CGMs), blood glucose meters or other electronic devices used for diabetes management.

The FDA’s action creates a new regulatory classification, so future ACE insulin pumps will be able to go through the faster 510(k) review process.

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