The CGM world just got more interesting
According to an article posted by The Manlia Times
“Biolinq Incorporated, a pioneering developer of precision multi-analyte biosensors to improve metabolic health, today announced the U.S. Food and Drug Administration has granted De Novo Classification for its lead product, Biolinq Shine™. With this classification, Biolinq has a clear path forward to scale a new generation of wearable sensors designed for comfort, simplicity, and global reach.”
A couple of interesting points about the Shine and Biolinq’s strategy. Rather than take on Dexcom and Abbott directly targeting insulin using patients Biolinq is targeting non-insulin using Type 2 . . .
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