Dexcom receives FDA approval for G5 touchscreen receiver – April 7, 2017

According to FDA’s March PMA approval list, Dexcom received approval for its new G5 touchscreen receiver early last month. The news was not accompanied by a press release, but this has been long awaited following the 2Q16 submission – surprisingly lengthy, given Dexcom’s strong relationship with the FDA, but we know the FDA is very busy right now. At JPM, Dexcom positioned this as a “2017” launch, and presumably that is well on track now with the approval in hand. As we’ve covered previously, this receiver will be more durable (i.e., less susceptible to wear) and offer a user interface in line with the G5 mobile app. We hope to hear more concrete launch timing and details on the 1Q17 call. Dexcom’s JPM slides did not share a picture of the new receiver, but it will certainly give the current model a welcome facelift. Another possible advantage is a larger and more readable/customizable receiver screen, which might especially benefit Medicare beneficiaries with impaired vision. (CMS will pay Dexcom $236-$277 per durable receiver.) We also wonder what the new receiver costs to manufacture vs. the older version – presumably it’s the same price or even less expensive, given the continually dropping price of consumer electronics. Meanwhile, Dexcom has two other major pipeline submissions under review: the one-touch inserter and lower-profile transmitter, G5x (submitted in 3Q16, FDA questions received in February) and the very important Android version of G5 (launch expected by mid-year).

-- by Adam Brown and Kelly Close