FDA Approves Dexcom G4 Share Receiver wo Dock & Classifies Secondary Display as Class II

The FDA announced on Friday the permission to market the first medical mobile applications for continuous glucose monitoring.

Dexcom announces the plan for rolling out their new G4 receivers in early March 2015 which will communicate with these applications using an iPhone or iPod Touch without the need for a docking station. This is different than the planned G5 system where the transmitter will communicate directly with a mobile device, eliminating the need for the receiver.

Read the FDA Announcement.

Read Dexcom's Press Release.

Listen to today's Dexcom Investor Call.
On this call the categorization of secondary display as Class II is discussed. Secondary display applications will not need specific FDA approval although will still need proper documentation and validation to comply with FDA requirements. Any device, application or improvement affecting the primary display of data will remain Class III medical devices requiring specific FDA approval.