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Dexcom G6 Finally Gets Official Classification

 
• By Brian Bossetta

After nearly four years of treating the Dexcom glucose monitoring system as moderate-risk class II, the US FDA made the designation official.

DEXCOM G6
• Source: Alamy

The US Food and Drug Administration has officially granted a request from DexCom Inc. to designate its G6 continuous glucose monitoring (CGM) system as moderate-risk class II.

The FDA first received the request from the company to grant de novo classification to the Dexcom G6 in 2017, and since March 2018 has been treating the device as...

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