FDA Advisory Committee Votes in Favor of Non-Adjunctive Label for DexCom G5 Mobile CGM System
- Conference call scheduled for 8:30AM ET
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 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.”
Conference Call
DexCom management will hold a conference call to discuss the meeting starting at 8:30 a.m. (Eastern Time) today, Friday, July 22.
To listen to the conference call, please dial (888) 771-4371 (US/Canada) or (847) 585-4405 (International) and use the confirmation number “43019542" approximately five minutes prior to the start time.
The conference call will be concurrently webcast. The link to the webcast will be available on the DexCom, Inc. website here.
About DexCom, Inc.
DexCom, Inc., headquartered in San Diego, CA, 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. With exceptional performance, patient comfort and lifestyle flexibility at the heart of its technology, users have consistently ranked DexCom highest in customer satisfaction and loyalty. For more information on the DexCom CGM, visit www.dexcom.com.
CONSUMER CONTACT:
Caren Begun, 201-396-8551
INVESTOR CONTACT:
Steve Pacelli, 858-200-0200
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SOURCE DexCom, Inc.
