So, at D-DATA 2018 (adjunct to the ADA Scientific Sessions), today the FDA added further color on yesterday's approval of Tandem's PLGS system. Apparently, the approval was two-pronged: allowing for the system to work with both the Dexcom G5 (specifically), or ANY iCGM (of which G6 is the only one currently available).
Additionally, they specifically said that the "any iCGM" approval will allow Tandem to add support for any CGM approved by the FDA as an iCGM without needing to re-submit the system for another round of approvals.
In my mind, the implications of this new approval pathway are potentially huge, with companies now being heavily incentivized to move towards iCGM for flexibility on both the glucose monitoring side (drive any automated system with your company's iCGM), and on the insulin delivery side (patients may want pumps that support more CGM options).
Not to be overlooked also is the fact that Tandem filed the supplement to their PLGS application to include the G6 only within the last month or so, and didn't anticipate G6 integration approval until almost the end of the year. The rapid approval would seem to indicate that the new iCGM class will be treated favorably by the FDA for approvals of new products that integrate iCGMs, potentially accelerating development and reducing time-to-market for manufacturers of new (or updated) delivery systems and algorithms.
Any thoughts from /r/diabetes on this?
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