Biolinq Shine Receives FDA Clearance as First Needle-Free Glucose Sensor
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The agency’s de novo clearance pitches the Shine sensor as providing a more qualitative view of the user’s glucose ranges and trends—not as a CGM that supplies the quantitative measurements used to calculate insulin doses.
In April, the San Diego-based company announced a $100 million series C round, stating that it would help launch its commercialization plans. Biolinq has also been developing an electrochemical microsensor array that tracks lactate and ketone levels, in addition to glucose monitoring
https://www.fiercebiotech.com/medtech/biolinqs-color-coded-glucose-sensor-patch-nets-fda-clearance
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Looking at it it appears to be quite vague.
A first-of-its-kind, simple LED light system to reveal glucose excursions in real time, even without a phone. Blue means you’re in target range. Not blue? Actionable insights can help support healthier decisions in the moment.
I like the attempts to improve sensing, but I have used the needle based systems and not had any pain from implanting them. I really don’t see the utility of a quite vague glucose indicator.
The user is not intended to take medical action based on the device output without consultation with a qualified healthcare professional.
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