Next month the FDA is hosting a public advisory committee meeting to discuss a change to the intended use of Dexcom's G5 Mobile Continuous Glucose Monitoring System (CGM) device that would allow the company to market the G5 as a CGM patients can base treatment decisions on.
Currently, Dexcom's CGMs are considered adjunctive devices, which means they carry an asterisk that notes they are intended...
When the Apple Watch launched last year, Dexcom announced that it would have an Apple Watch app ready for its G4 continuous glucose monitor system, and it did. While users could see their CGM data on their wrist, that data had to go on a long trip to get there. With the G4, the implant sent data to a receiver box which sent data to the phone which sent data to the watch, and the user needed to...
The FDA has approved San Diego, California-based Dexcom for a Bluetooth-enabled continuous glucose monitor (CGM), called the G5 Mobile CGM system.
Correction: A previous version of this article incorrectly stated the device had a 510(k) clearance when in fact it had a PMA approval.
Unlike the company's previous connected CGM devices, the G5 Mobile CGM System has Bluetooth built right in to the...
