DexCom, Inc., the leader in continuous glucose monitoring (CGM) for patients with diabetes, announced that the Clinical Chemistry and Clinical Toxicology Devices Panel of the US 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 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."

DexCom, Inc., headquartered in San Diego, California, is dedicated to helping people better manage their diabetes by developing and marketing continuous glucose monitoring (CGM) products and tools for adult and pediatric patients.