The US Food and Drug Administration signaled its interest in helping to bring continuous glucose monitoring to hospital inpatients by granting its breakthrough device designation to DexCom’s continuous glucose monitoring system.
Dexcom Works With FDA To Bring CGM To Hospitals After Pandemic
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.
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Tempering expectations on the immediate market impact for the upgraded continuous glucose monitor, Dexcom notes insurance coverage and pump integrations will take time to finalize.
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