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Dexcom made a significant design change to a component used in its sensors and did not adequately validate the change, according to the warning letter.
Dexcom has obtained European approval for the latest generation of its wearable diabetes sensor, the G7 continuous glucose monitor, for adults and children ages two and up.
A trade-off with the Dexcom G6: Because there are no more finger sticks, FDA has required that the sensor shut off after 10 days, so that patients change sensors to ensure accuracy.
Designed to be 60% smaller than its predecessor—Dexcom’s best-selling G6, which first debuted in 2018—the low-profile, disposable G7 includes a combined applicator and transmitter, and it ...
Dexcom G6 uses a small wearable sensor and transmitter to continuously measure and send glucose levels wirelessly to a compatible smart device or receiver, giving patients real-time glucose data ...
The Dexcom G6 CGM System uses a small, wearable sensor and transmitter to continuously measure and send glucose levels wirelessly to a compatible smart device † or receiver, giving those living ...
The world’s most connected continuous glucose monitoring system,† Dexcom G6, is now the first and only CGM to connect with the Omnipod 5 Automated Insulin Delivery (AID) System in Germany.
The Dexcom G6 uses a small, wearable sensor and transmitter to continuously measure and send glucose levels wirelessly to a compatible smart device † or receiver, giving those living with ...