- 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)