The FDA said it’s planning to convene an advisory panel in July to consider expanding the indication for the G5 mobile continuous glucose monitor made by Dexcom (NSDQ:DXCM).
The Center for Devices & Radiological Health’s chemistry & toxicology panel is slated to meet July 21 to recommend whether the intended use for the Dexcom G5 should be changed so that diabetics can use it to replace finger-stick blood glucose monitoring; the G5 device measures glucose using the interstitial fluid surrounding cells just under the skin.
Changing the device’s intended use would mean patients could make treatment decision based on the G5’s interstitial glucose readings, rather than merely for tracking them and predicting trends.
The Center for Devices & Radiological Health’s chemistry & toxicology panel is slated to meet July 21 to recommend whether the intended use for the Dexcom G5 should be changed so that diabetics can use it to replace finger-stick blood glucose monitoring; the G5 device measures glucose using the interstitial fluid surrounding cells just under the skin.
Changing the device’s intended use would mean patients could make treatment decision based on the G5’s interstitial glucose readings, rather than merely for tracking them and predicting trends.