The conference room erupted in applause July 21 as an FDA advisory panel overwhelmingly voted to recommend Dexcom's G5 Continuous Glucose Monitor system as a replacement, rather than simply an adjunct, to conventional finger-stick testing for diabetics. In an eight to two vote the Clinical Chemistry and Clinical Toxicology Devices Panel voted the benefits of the expanded indication outweigh the risks.
Current labeling for CGMs made by the two US manufacturers of CGMs, Dexcom and Medtronic, includes a requirement for a confirmatory
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