Biolinq Shine has received FDA clearance for over-the-counter use, expanding access to the needle-free glucose sensor nearly one year after it received De Novo Classification. This clearance allows adults ages 22 and older who are not using insulin to access Shine without a prescription. The new clearance builds on the device’s original regulatory milestone and moves Shine into the growing consumer glucose-monitoring market.

Shine is designed to provide a simple view of glucose, activity, and sleep through a single wearable. The forearm-worn device uses semiconductor-based microsensors positioned close to the skin without the traditional insertion needle used by most continuous glucose monitors (CGMs). It also features an integrated LED display that provides color-coded feedback on whether glucose is within or outside a target range, allowing the sensor to provide information even without a smartphone. An optional companion app provides additional insights into how meals, movement, and sleep can affect glucose patterns.

The device remains intended for general awareness of glucose patterns rather than medical decision-making. Shine does not provide quantitative glucose values for insulin dosing or medication adjustments. Developers plan to have the sensors measure additional analytes in the future, including lactate, and ketones. There are more multianalyte sensors in the works for people with diabetes including Libre Duo 10 Day, which is coming to the U.S. before the end of the year, and Dexcom G8.