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FDA Advisory Committee Votes in Favor of Non-Adjunctive Label for DexCom G5 Mobile CGM System

SAN DIEGO, July 22, 2016 /PRNewswire/ -- DexCom, Inc. (NASDAQ: DXCM), the leader in continuous glucose monitoring (CGM) for patients with diabetes, announced today that the Clinical Chemistry and Clinical Toxicology Devices Panel of the U.S. Food and Drug Administration (FDA) voted in favor of the proposed non-adjunctive indication for the DexCom G5 Mobile CGM system. This indication would designate the G5 Mobile CGM system as a replacement to fingerstick glucose testing for diabetes treatment decisions.

Specifically, the panel voted:

  • 8-2 supporting that there is reasonable assurance that the DexCom G5 Mobile CGM system is safe for the proposed indications for use,
  • 9-1 supporting that there is reasonable assurance that the DexCom G5...

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