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Insulin Delivery

FDA Clears Beta Bionics iLet ACE Pump and iLet Dosing Decision Software

Here is a brief preview of this blast: FDA announced it has cleared the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software, which form the insulin-only iLet Bionic Pancreas. A press release from Beta Bionics has not yet been observed. Recall, in May 2022, Beta Bionics presented results from its pivotal iLet Bionic Pancreas trial (view CT.gov record) at ATTD 2023 and disclosed that data from the trial was included in the comprehensive submission packaged filed with FDA (previous FENIX insight). Below, FENIX provides initial thoughts on the iLet approval.

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.