FDA Approves Dexcom G6, A Fully Integrated CGM

Big news for CGM users:

The FDA announced today that it has approved the Dexcom G6 continuous glucose monitor system (CGM).

From the FDA press release, here are 6 facts to know:

  1. It’s the first CGM given formal FDA approval to be be “used as part of an integrated system with other compatible medical devices and electronic interfaces”.
  2. It doesn’t require a receiver. It can talk directly to a smartphone or to a compatible pump system. If that pump is an automated insulin delivery pump system, then the pump can adjust insulin delivery based on these readings.
  3. It has been cleared for use for children ages 2 and up and adults with diabetes.
  4. The CGM is a patch about the size of a quarter.
  5. It’s been designated a new class II device under FDA regulations, meaning it will pave the way for the regulatory process of the development of other future integrated CGMs.
  6. Its sensor is designed to minimize the possibility of false glucose readings from those with diabetes who take acetaminophen.

FDA approval for the Dexcom G6 helps Dexcom regain momentum in the CGM marketplace. In the past year, the device-maker has seen increased competition with the release of the Abbott Freestyle Libre Flash and Medtronic’s standalone Guardian Connect.

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To read the full FDA announcement, go to https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm602870.htm?platform=hootsuite.

3/28/2018 – An earlier caption for this story was unclear about the role of a transmitter in the system. The caption was corrected. 

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