Medscape October 10, 2025
The US FDA has granted a De Novo Classification for the Biolinq Shine, a novel real-time glucose sensor for people with type 2 diabetes (T2D) not on insulin.
The new classification allows the company to market the product in the US as a medical device, requiring a prescription. This new category of biosensors operates autonomously, working right out of the box with or without a phone or mobile app, using an integrated glucose display on the wearable device. Further data for other metrics, such as activity and sleep, are available with a mobile app.
The glucose data is displayed via a primary color-coded LED display, with blue for 70-180 mg/dL (ie, time in range), yellow for more than 180 mg/dL,...
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