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FDA OKs expanded use for DexCom's G5 glucose monitoring system; shares up 3%

Dec. 20, 2016 3:16 PM ETDexCom, Inc. (DXCM) StockBy: Douglas W. House, SA News Editor
  • The FDA has signed off on the use of DexCom's (NASDAQ:DXCM +2.9%) G5 Continuous Glucose Monitoring System to make diabetes treatment decisions in patients at least two years old without the need for a fingerstick blood test to confirm the result, a first for such a device.
  • The G5 still requires two daily fingerstick samples to calibrate the system, but none to make treatment decisions.
  • The product uses a small sensor wire inserted just below the skin to continuously measure glucose levels. Real-time results are sent wirelessly every five minutes to a dedicated receiver and compatible mobile device.
  • The approval was expected considering a positive Ad Comm vote backing the expanded use in July.
  • Previously: FDA Ad Comm backs use of Dexcom's G5 CGM as a replacement for blood glucose meter (July 21)

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