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Glucose Monitoring

Libre 2 US Approval Was Worth the Wait for Abbott, but Not Its Pump Partners

Here is a brief preview of this blast: Abbott announced FDA approval of the Libre 2 iCGM in patients 4 years of age and older; however, the initial approval comes without closed-loop compatibility. According to FDA's 510(k) database, Libre 2 was approved on Friday, June 12, but FDA typically doesn't update the database until Monday. Recall, Libre 2 approval had been delayed for undisclosed reasons, but FENIX recently anticipated a near-term US approval with the closure of Bigfoot’s Series C (previous FENIX insight). Below, FENIX provides thoughts on the Libre 2 approval, a comparative analysis with the Dexcom G6, and potential implications to other CGM manufacturers including Medtronic, Senseonics, Lifescan, Waveform, and Nemaura.

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.