Dexcom Says FDA Published Briefing Documents Before Advisory Committee Meeting

Dexcom, Inc. DXCM revealed that the Food and Drug Administration in the United States has published the briefing documents ahead of the July 21 meeting of the Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee. According to the company, the meeting would be held at the Hilton Washington DC North in Gaithersburg, MD.

Dexcom said the documents provided context for the discussion on its premarket approval application supplement (PMA-S) for a planned change in the intended use of its G5 Mobile CGM System. This was to enable a patient to use the device to make diabetes treatment decisions based on the interstitial fluid glucose concentration reported by the CGM.

The company indicated it would hold a conference call to discuss the meeting starting at 8:30 a.m. ET on July 22.