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Podcast: FDA Panel Overwhelmingly Votes For Dexcom CGM to Replace Finger Sticks

The US FDA's Clinical Chemistry and Clinical Toxicology Devices Panel voted eight to two to recommend Dexcom's G5 Continuous Glucose Monitor to replace finger-stick testing in diabetic patients over the age of two. Also, a post-panel podcast chat with Dexcom's Steve Pacelli.

Event

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 finger-stick test before adjusting insulin levels.

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