SAN DIEGO--(BUSINESS WIRE)--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.