Tandem Control IQ Approved as first “iAlgorithm” Device

Tandem announced it received FDA clearance for Control IQ as the first “interoperable automated glycemic controller device” (denoted as iAGC below and previously described as “iAlgorithm” by FENIX). Notably, FDA also issued a press release regarding the approval. With Control IQ’s approval, FDA has established new special controls for the final component of interoperable systems. Dexcom’s G6 CGM was the first interoperable CGM (iCGM), and Tandem’s t:slim X2 was the first alternate controller enabled pump (ACE pump). Below, FENIX provides insights on the Control IQ approval in the context of future interoperable systems in development as well as thoughts on how JDRF’s new plea to UHC could help Tandem expand access.

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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