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Re: edro post# 12611

Monday, 12/05/2022 10:31:21 AM

Monday, December 05, 2022 10:31:21 AM

Post# of 13116
The FDA clearance they received was for their diabetes management platform (software), but they are bringing to market a new low cost CGM for human use that will use their platform (assumably). That means they have to get FDA clearance for the CGM itself since it is a medical device.
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