The U.S. FDA approved DexCom Inc.'s G5 Mobile CGM system, a continuous glucose monitoring system, with a non-adjunctive designation.
In July, an FDA selected panel of experts deemed the system safe and effective, with its benefits outweighing the risks with the proposed indications for use. The FDA has followed the expert recommendation and made the system the first and only continuous glucose monitoring system in the U.S. to have a non-adjunctive designation.
The new non-adjunctive indication expands the use of the system as a replacement to finger stick glucose testing for diabetes treatment decisions. With the new label indication, the system only requires two finger pricks per day for calibration.