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

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Additional Information

Additional Relevant Details 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 Mobile CGM system is effective for the proposed indications for use, and
  • 8-2 supporting that the benefits of the DexCom G5 Mobile CGM system outweigh the risks for the proposed indications for use.
"This recommendation is a big milestone for people with diabetes," said Kevin Sayer, DexCom President and Chief Executive Officer. "The diabetes community turned out in force to support this decision. We commend the FDA for bringing this important subject into a public forum, and thank the panel members, as well as the public speakers for their willingness to participate. We look forward to continued positive discussions with the FDA as we seek the agency's approval of our application."
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Catalyst Date
Occurred on:
Jul 22, 2016
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