New Type of Glucose Sensor to Enter US Market

 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, and red for less than 70 mg/dL. Rather than an introducer needle, it uses a shallow microsensor embedded just below the skin surface. The device is worn on the forearm for 5 days.

Diabetes technology expert David T. Ahn, MD, Chief of Diabetes Services for Hoag Hospital, Newport Beach, California, told Medscape Medical News that the Biolinq Shine “represents a novel category in glucose monitoring that I feel works as a wellness-oriented device incorporating elements of continuous glucose sensing rather than a medical [continuous glucose monitor] adapted for wellness. Compared to a CGM, it might seem lacking with a 5-day wear period and no specific glucose values, but compared to an Apple Watch or Oura Ring or as a complement to them, it starts to make sense.”

Ahn added, “by focusing on time-in-range rather than precise glucose numbers, Biolinq is encouraging a paradigm shift — simplifying metabolic feedback for a broader audience while still offering meaningful insight. I see this as an early but important step toward smaller, simpler, more affordable, and more integrated metabolic sensors in the future.”

The Biolinq Shine is expected to be available in 2026.

Ahn has received speaker’s and/or consulting fees from Abbott, Ascensia, Lilly, Mannkind, Insulet, Novo, Sequel, and Xeris. He has received consulting and advisory fees from Lilly, Ascensia, and Mannkind. 

https://www.medscape.com/viewarticle/new-type-glucose-sensor-enter-us-market-2025a1000re3