DexCom recently announced that the U.S. Food and Drug Administration’s (FDA) Clinical Chemistry and Clinical Toxicology Devices Panel has voted to approve the DexCom G5 Mobile CGM system’s proposed non-adjunctive indication.
DexCom is a leader in continuous glucose monitoring (CGM) for diabetic patients.
"This recommendation is a big milestone for people with diabetes," President and CEO of DexCom Kevin Sayer said. "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."
With the newly approved indication, the G5 system could replace fingerstick glucose testing as a diabetes treatment decision.
The panel voted 8-2 in support of the safety of the proposed indications for use of the G5 system, 9-1 in support of the effectiveness of the proposed indications for usage and 8-2 that the benefits of proposed indications for use outweigh the risks.
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