Tag Archives: icgm

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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Dexcom Non-intensive G6 CGM Updated Approval; Dexcom G5 Receiver Recall; FDA Concludes MET NDMA Impurity Investigation

A series of diabetes-related news has been observed including a new 510(k) clearance for Dexcom’s G6 iCGM in non-intensive diabetes management, Dexcom G5 Mobile Class 2 Device recall, and FDA finalized its investigation into potential metformin impurities. Below, FENIX provides highlights and insights for the respective news items.

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Dexcom and Livongo Q3 ’19 Earnings Updates

Dexcom and Livongo hosted their Q3 ’19 earnings calls and provided updates to their respective businesses. Below, FENIX provides highlights and insights from the respective earnings calls.

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Abbott and Tandem partnership; Livongo partners with VSP Vision Care

Abbott and Tandem Diabetes Care announced plans to develop an integrated diabetes solution utilizing Abbott’s glucose monitoring sensors (Libre) and Tandem’s insulin delivery systems. Additionally, Livongo and VSP Vision Care announced a partnership to expand eye care outreach efforts to Livongo members with diabetes. Below, FENIX provides context and broader implications on these partnerships.

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