news  2 0 1 6

An FDA committee agree to approve the data from the CGM system Dexcom G5 to be use to adjust insulin doses

July 21, 2016 marked a milestone for the CGM world that will lead in the near future to develop a complete artificial pancreas.

The FDA's Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee voted in favor of approval of Dexcom's G5 Mobile Continuous Glucose Monitoring (CGM) System as a replacement for users' blood glucose meters and to make treatment decisions based on the results from the G5. The filing was submitted as a supplement to its previously approved premarket approval application (PMA).

Specifically, the Panel voted 8-2 in favor of the safety of the G5, 9-1 backing its effectiveness and 8-2 that the benefits outweigh the risks.
Source: U S Food and Drug Administration (FDA)
back to news 2016