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.
About The Author
Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.
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