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Thoughts on Tandem Basal IQ iAGC Designation

Tandem recently announced it received FDA clearance for its Basal IQ algorithm as an Interoperable Automated Glycemic Controller (iAGC). Basal IQ is the second algorithm to receive the iAGC designation behind Tandem’s Control IQ (approved in December 2019). Below, FENIX provides thoughts on the Basal IQ iAGC clearance in the context of FDA’s iAGC special controls as well as potential implications to other glycemic control algorithm developers.

About The Author

Matthew Maryniak

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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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