Tag Archives: CGM

Dexcom Receives FDA Clearance for G7 15 Day CGM

Dexcom announced it received FDA clearance for its G7 15 Day CGM for people over the age of 18 with diabetes. The G7 15 Day CGM is expected to launch in H2 2025, and the company noted it is working to ensure its new CGM is compatible with its current insulin pump partners at launch. Recall, in October 2024, Dexcom disclosed that it submitted the 15 Day for FDA approval (previous FENIX insight). Below, FENIX provides highlights and insights on the approval.

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Abbott/Medtronic Strategic Partnership; Simplera Updates; Madrigal and MannKind Q2 ’24 Earnings

Three cardiometabolic-related news items have been observed: Abbott announced a partnership with Medtronic for the development of a new CGM that is exclusively compatible with Medtronic’s AID and smart insulin pens (press release); Medtronic announced the FDA approval of its Simplera CGM (press release); Madrigal (press release; slides) and MannKind (press release; slides) hosted their respective Q2 ’24 earnings. Below, FENIX provides highlights and insights for the respective news items, along with an analysis of the Abbott/Medtronic partnership.

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ADA 2024 Key Press Releases (June 24)

On the final day of the ADA 2024 conference, nine cardiometabolic-related news items have been observed from Novo Nordisk, Adipo Therapeutics, Trinity Biotech, Alnylam, Viking, Teva, Teladoc Health, and CHMP. Below, FENIX provides context and analysis for the announcements, including thoughts on the potential FLOW label.

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New CGM Player to Enter the Market

Allez Health announced it secured $60M in a Series A+ financing round led by Osang Healthcare Co. Ltd. and with participation from existing investors. For context, Allez (formerly called Zense-Life; view website) is an emerging biosensor venture founded by veterans in the CGM space. The company is said to be developing a CGM biosensor platform with novel sensor technology that aims to “disrupt today’s cost barrier while enhancing performance and user experience.” Stay tuned for an exclusive, in-depth FENIX interview with the Allez founders, Leif Bowman and Bob Boock. Below, FENIX provides initial insight into Allez and poses key questions about the novel sensor platform.

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Eversense CGM Receives iCGM Designation

Senseonics announced its implantable Eversense CGM has been granted iCGM designation by FDA. Following the iCGM designation, the company stated it plans to advance partnership discussions with various pump manufacturers for AID integration. Below, FENIX provides brief insight into the potential impact of receiving the iCGM designation for Senseonics/Eversense.

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