Category Archives: Glucose Monitoring

iCGM FDA “Special Controls” Analysis

In conjunction with the Dexcom G6 approval FDA created a new device category under class II defined as “integrated continuous glucose monitoring,” or iCGM. Below, FENIX has provided an analysis and summary of this class’ FDA controls in the context of future CGM development by manufacturers such as Dexcom, Abbott, Medtronic, and Senseonics.

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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FENIX Analysis: Thoughts on Dexcom G6 Approval

FDA and Dexcom announced approval of the Dexcom G6 CGM after a notably short 6-month review time, suggesting increased FDA comfort with CGM technology. The new device is the first real-time CGM approved for standalone and interoperable use. Launch is anticipated in Q2 ‘18, and Dexcom is projected to have a significant presence at ADA.

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.

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.

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.

J&J receives offer for LifeScan BGM business

J&J announced it has received an offer from Platinum Equity to purchase LifeScan for $2.1B. According to the press release, the acceptance period for the offer ends June 15, 2018 with closing of the deal to occur by YE ’18. Below, FENIX provides insight on the potential opportunity that Platinum Equity may see for the LifeScan business.

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.

JPM Day 2: Sanofi, Lilly, Lexicon, Dexcom and more

During Day 2 of JPM, presentations ranged across both diabetes drug (Sanofi, Lilly, Lexicon, and Mylan) and device manufacturers (Dexcom, Insulet, and Roche), although Mylan and Roche did not discuss their diabetes portfolios. Below, find key takeaways from JPM followed by more in-depth coverage.

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.

Dexcom Q4 ’17 Earnings Update

Dexcom hosted its Q4 ’17 earnings call and provided updates to its CGM business. Of note, Dexcom disclosed that while they are working with FDA on not requiring calibrations for G6, it will still allow calibrations if the user chooses. Below are highlights from the call.

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.

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.

Dexcom displays representation of Lilly connected insulin pen

It was reported on Twitter that at ATTD 2018, Dexcom displayed a slide (pictured below) showing a representation of a smart insulin pen. Additionally, Dexcom presented information on the “fully enhanced Dexcom G6 CGM system” including “Urgent Low Soon Alerts.”

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.

Glooko insulin titration app FDA cleared

Glooko announced FDA clearance of its Mobile Insulin Dosing System (MIDS). According to Glooko, the system analyzes FPG and recommends dose adjustments based on a pre-configured HCP plan or published clinical guidelines.

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.

Abbott FreeStyle Libre to utilize Apple’s NFC technology

Abbott’s FreeStyle LibreLink is reportedly the first third-party iOS app to utilize Apple’s NFC technology (previously NFC use was limited to Apple Pay). The LibreLink app is believed to currently only be available in Europe, but it is assumed a US version is on the horizon.

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.