Tandem Diabetes received a brand new classification from the FDA for its t:slim X2 insulin pump. The device is the first in a category known as Alternate Controller Enabled Infusion Pumps (ACE pumps). According to the company, the associated indication is that the pump is “able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices.”
“This new classification of the t:slim X2 pump provides more flexibility for us as we make improvements to current products, create new products, and collaborate with best-in-class companies in the development of future automated insulin delivery systems,” in a statement said Kim Blickenstaff, president and CEO of Tandem Diabetes Care.
The t:slim X2 features Basal-IQ technology, which predicts low levels of glucose and suspends the delivery of insulin. It uses Bluetooth wireless to connect to a smartphone that can display the status of the accompanying glucose monitor and what the pump has been up to.
Here’s a promo video for the t:slim X2:
Flashbacks: t:slim X2 Insulin Pump with Dexcom G5 CGM Connectivity Cleared in EU…; Tandem Diabetes to Release Self-Updating t:slim X2 Insulin Pump…
Product page: t:slim X2 Insulin Pump…
Via: Tandem Diabetes…