Tag Archives: SENS

FENIX Analysis: Senseonics FDA Adcom Briefing Documents; Dexcom G6 Approval

Briefing documents for the Senseonics implantable Eversense CGM were posted today by FDA in advance of the March 29, 2018 adcom. Also of note, FDA today announced approval of the Dexcom G6 and a new lower risk classification of interoperable CGM (“iCGM”). Below, FENIX has analyzed the key issues anticipated to be discussed during the adcom.

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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CGM thoughts: Senseonics vs. Dexcom and Abbott

In light of the recent journal publication of PRECISE II, the US pivotal IDE trial for Senseonics’s Eversense implantable CGM, FENIX has conducted a comparative analysis vs. Abbott Freestyle Libre and Dexcom G5 Mobile, with a particular focus on sensor accuracy across glucose ranges.

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.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.