Breaking News! The FDA decision on Dexcom G5 Dosing Is In!
Scott Benner
Thanks to Bennet and our friends at DPAC for the up-to-the minute information!
from Diabetes Patient Advocacy Coalition
FDA's Advisory Committee meeting just voted to recommend approval of the expansion of the Dexcom G5 CGM label.
The results are in and the FDA panel has voted the following for the labeling change of the Dexcom G5 Continuous Glucose Monitoring System:
1. Is there reasonable assurance that the Dexcom G5 Continuous Glucose Monitoring System is safe for the proposed indications of use? VOTE - YES: 8 NO: 2
2. Is there reasonable assurance that the Dexcom G5 Continuous Glucose Monitoring System is effective for the proposed indications for use? VOTE - YES: 9 NO: 1
3. Do the benefits of the Dexcom G5 Continuous Glucose Monitoring System for the proposed indications of use outweigh the risks of the Dexcom G5 Continuous Glucose Monitoring System for the proposed indications for use. VOTE - YES: 8 NO: 2
