Thoughts on iPump Special Controls

Yesterday, FDA approved the first interoperable pump through the de novo pathway and created a new pump category called “alternate controller enabled” (ACE) infusion pump. With the approval of the new class, FDA established “special controls” that must be met in order to qualify as an ACE pump, similar to Dexcom’s G6 iCGM approval in March 2018. Below, FENIX provides analysis and summary of these controls as well as thoughts on how achievable the ACE special controls are compared to the iCGM special controls.

About The Author

Matthew Maryniak

President of Fenix Group International

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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