FDA Posts Briefing Documents Ahead of Advisory Committee Meeting
July 19 2016 - 8:32AM
Business Wire
Clinical Chemistry and Clinical Toxicology Devices Panel to
Convene on July 21
Dexcom, Inc. (NASDAQ:DXCM), a leader in continuous glucose
monitoring (CGM) for patients with diabetes, announced today that
the US Food and Drug Administration (FDA) published the briefing
documents ahead of the July 21, 2016 meeting of the Clinical
Chemistry and Clinical Toxicology Devices Panel of the Medical
Devices Advisory Committee. The meeting will be held at the Hilton
Washington DC North in Gaithersburg, MD.
The documents provide context for the discussion around Dexcom’s
premarket approval application supplement (PMA-S) for a proposed
change in the intended use of Dexcom’s G5 Mobile CGM System so that
a patient can use the device to make diabetes treatment decisions
based on the interstitial fluid glucose concentration reported by
the CGM.
The briefing materials can be accessed through the FDA’s
website:
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ClinicalChemistryandClinicalToxicologyDevicesPanel/ucm511565.htm.
Dexcom management will hold a conference call to discuss the
meeting starting at 8:30 a.m. (Eastern Time) on Friday, July 22
2016.
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 at
www.dexcom.com by navigating to “Our Company,” then “Investor
Relations,” and then “Events and Webcasts,” and will be archived
there for future reference.
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.
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for Dexcom, Inc.CONSUMER CONTACT:Caren
Begun, 201-396-8551orINVESTOR CONTACT:Steven Pacelli,
858-200-0200
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