Category Archives: Glucose Monitoring

Eversense 365 Day CGM Receives FDA Clearance

Senseonics Holdings and Ascensia Diabetes Care announced FDA cleared the implantable Eversense 365 CGM as an iCGM system for people with T1DM and T2DM aged 18 years and older. Senseonics stated it is continuing to progress partnership discussions with various pump manufacturers looking to leverage Eversense 365 with AID systems. Ascensia plans to initiate the US launch of Eversense 365 in early Q4 2024. Below, FENIX provides brief insights into the 510(k) clearance.

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Abbott Launches Lingo OTC CGM in the US

Abbott announced Lingo, its OTC CGM, is now available for purchase in the US via its website (view website). The launch announcement comes shortly after Dexcom announced the launch of its own Stelo OTC CGM (previous FENIX insight). Below, FENIX has conducted an analysis of the Lingo product, website, and pricing.

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FENIX Analysis: Pump/AID Promotional Materials Post-ADA 2024

In this final installment of the post-ADA promotional series, FENIX is evaluating pumps and AID systems from Insulet, Tandem, Medtronic, and Beta Bionics. In case you missed it, FENIX also conducted analyses of GLP-1RA (previous FENIX insight) and CGM (previous FENIX insight) promotional material from ADA 2024.

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Dexcom launches Stelo OTC Glucose Biosensor in the US

Dexcom announced Stelo, its OTC “Glucose Biosensor,” is now available for purchase in the US via its website (view website). Recall, in March 2024, FDA cleared Stelo for use without a prescription for T2DM patients 18 years and older who do not use insulin (previous FENIX insight). Additionally, the company is initiating its “Welcome to Stelo: Personalizing Choices, Revolutionizing Glucose Health” webinar series on August 27, 2024 (view website). Below, FENIX has conducted an analysis of the Stelo product, website, and pricing, including thoughts on Dexcom’s Stelo branding strategy and the impending launch of Abbott’s own OTC products (Lingo and Rio).

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FENIX Analysis: CGM Promotional Materials Post-ADA 2024

In this second installment of the post-ADA promotional materials analysis, FENIX is evaluating CGMs from Dexcom, Abbott, and Ascensia/Senseonics. Medtronic did not have any leave-behind promotional materials for its CGM portfolio. The final installment will focus on insulin pumps/AID systems. Of note, neither Dexcom nor Abbott promoted their respective OTC CGM products (Stelo, Rio, and Lingo), although the launches are anticipated in the near future (previous FENIX insight; previous FENIX insight).

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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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