FDA Approved: New Biosensor for Sleep, Activity + Glucose

On September 25, 2025, the Food and Drug Administration (FDA) approved the first insertion-free glucose sensor, the Biolinq Shine. 

What is the Biolinq Shine?

The Biolinq Shine is a product of Biolinq Incorporated, a healthcare technology company based in San Diego, California. This is the first wearable biosensor that monitors glucose levels, activity and sleep data with a single device, which works with or without a phone. 

This sensor is intended for people who are not on insulin, establishing a new regulatory category for wearable glucose sensors. It signals the FDA’s willingness to expand continuous monitoring beyond insulin-dependent populations. 

Who will the Biolinq Shine help?

This can benefit people with type 2 diabetes who are not on daily insulin therapy, people with prediabetes and those looking to fine-tune their health with real-time data to inform food and activity choices.

More people with access to glucose monitoring may also help more people catch undiagnosed prediabetes before it develops into type 2 diabetes. In the U.S., one in three people live with prediabetes. However, nine in 10 people with prediabetes have no idea they’re living with the condition. 

Getting continuous activity, sleep and glucose data can help people make daily adjustments to their lifestyles—improving their health along the way.

“The entire Biolinq team is thrilled about this regulatory milestone, which is a testament to the outstanding work by our team. We are grateful to the FDA for its rapid and rigorous review in establishing a new category of wearable biosensors,” said Rich Yang, ceo of Biolinq. “While we celebrate this tremendous milestone, we’ve only scratched the surface of what is possible with our multi-analyte-capable biosensor platform in supporting metabolic health for everyone.”

As the sensor is not as accurate as other glucose sensors on the market, it is intended for use by those who do not use insulin. 

How is the Biolinq Shine different?

The Biolinq Shine uses a primary color display that changes colors to indicate low, normal and high glucose levels—making the system easy to use and understand.

But what truly sets this glucose sensor apart is that it does not require a needle insertion, leading to less pain and more ease for the user. Many people are intimidated by painful insertions for continuous glucose monitoring (CGM), so this will be a helpful alternative to daily finger sticks for managing blood sugar levels.

“Biolinq Shine is a first-of-its-kind biosensor designed to support metabolic health for people with diabetes who are not dependent on insulin,” said Dan Bradbury, chairman of Biolinq. “By automatically tracking glucose levels, physical activity, and sleep information, this technology offers meaningful insights that can encourage healthier choices every day.”

Currently, 589 million adults live with diabetes around the world. The majority of them do not require insulin, but do require close management of blood glucose levels. Having more options for accessible technology will make managing health easier than ever before.

For more information on the Biolinq Shine and Biolinq Incorporated, visit their website and talk with your doctor.