Dexcom Plans European Launch Of G7 CGM; Hopes To Earn 510(k) This Summer
Dexcom received a CE mark for the G7 system in Europe and is awaiting a 510(k) clearance from the US FDA. The G7 is smaller and easier-to-use than the company's G6 CGM and will be more competitive with Abbott's FreeStyle Libre 3 CGM
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The FDA gave Dexcom and Abbott emergency permission to provide their continuous glucose monitoring systems to hospitals to be used by inpatients and hospital staff. Now the agency has granted Dexcom its breakthrough designation to accelerate the approval of Dexcom’s system for the in-hospital indication.
After nearly four years of treating the Dexcom glucose monitoring system as moderate-risk class II, the US FDA made the designation official.
Abbott says DexCom’s patent suits involve technology that was already the subject of a settlement, and raise venue questions.