$599
New iPump Pathway: Tandem t:slim X2 Approved as First Interoperable Pump
Today, FDA approved an interoperable version of Tandem’s t:slim X2 pump under the de novo pathway for a new insulin pump class called “alternate controller enabled” or ACE. Tandem has not yet issued a press release. This designation allows for the pump to be used with different components of an integrated insulin delivery system (e.g. CGM) with future iterations using the streamlined 510(k) process. As part of the approval, FDA has created special controls to meet the standard for ACE designation (similar to how FDA approved iCGM with special controls). Below, FENIX provides thoughts on the ACE category and implications to pump, CGM, and algorithm companies.