Tandem Diabetes Care announced that the Food and Drug Administration (FDA) has authorized the t:slim X2 insulin pump with interoperable technology, the first of the Alternate Controller Enabled Infusion Pumps (ACE pumps), which are devices intended for infusion of drugs into a patient. The interoperable pump allows for a more tailored diabetes management as it can be used with different components that make up diabetes therapy systems.
An ACE pump may include basal and bolus drug delivery under the skin at fixed or variable rates. It is designed to reliably and securely communicate with compatible, digitally connected devices (eg, automated insulin dosing software), to receive, execute, and confirm commands from these devices. ACE pumps can be used alone or in conjunction with digitally connected medical devices for the purpose of drug delivery.
The t:slim X2 pump is up to 38% smaller than other insulin pumps and can hold up to 300 Units of insulin. The Basal-IQ Technology helps reduce the frequency and duration of low-glucose events by predicting glucose levels 30 minutes ahead and suspending insulin if they are expected to fall. The Basal-IQ Technology helps reduce the frequency and duration of low-glucose events by predicting glucose levels 30 minutes ahead and suspending insulin if they are expected to fall <80mg/dL. Some of its other features include: a large color screen, a rechargeable battery, Bluetooth wireless technology, USB connectivity, and watertight construction. The pump can receive remote software updates using a personal computer and integrates continuous glucose monitoring.
The t:slim X2 insulin pump was reviewed through the de novo premarket review pathway designed for low-to-moderate devices of a new type. Along with their authorization, the Agency has established separate controls that describe the requirements needed to demonstrate acceptable pump performance.
Infection, bleeding, pain or skin irritations were risks associated with the use of t:slim X2 pump. Blockages or air bubbles in the tubing may affect delivery, which can result in hypoglycemia, hyperglycemia, or diabetic ketoacidosis.
“Having the t:slim X2 pump approved with this new designation, combined with its ability for remote software updates, will enable more efficient and predictable development of new systems with current and future technology partners, and allow faster delivery of new innovations to our customers,” stated John Sheridan, EVP and COO of Tandem Diabetes Care.
For more information visit TandemDiabetes.com.
This article originally appeared on MPR