Dexcom’s device can remotely monitor a patient’s glucose information and receive alert notifications from almost anywhere.Said device uses secure wireless connection via Bluetooth LE between a patient’s receiver and an app on the patient’s smartphone to transmit glucose information to apps on the mobile devices of up to five designated recipients, without the need for a dedicated docking cradle. These recipients can remotely monitor a patient’s glucose information and receive alert notifications from almost anywhere, initially via their Apple iPhone or iPod touch and in the future on Android devices, giving them peace of mind and reassurance when they are apart. The “Share” and “Follower” apps will be available on the Apple App Store at no charge.
The FDA reviewed the mobile app software used with the Dexcom Share receiver (both the “Share” and “Follow” apps) through its de novo classification process, a regulatory pathway for low- to moderate-risk medical devices that are novel and not substantially equivalent to any legally marketed device. The Agency has specifically classified the apps which communicate with the Share receiver as a secondary display device and has noted that similar devices which provide only secondary display for passive monitoring, but which do not replace the primary real-time display device, will be subject to the same classification, subject to compliance with certain special controls established by the Agency with respect to this secondary display. This means that devices which comply with appropriate FDA regulations, including the special controls, will not be required to submit a premarket notification to the FDA before marketing a secondary display device for continuous glucose monitoring. The Share receiver was still evaluated as a Class III medical device.