FDA Grants De Novo Classification to Needle-Free Glucose Monitor

The US Food and Drug Administration (FDA) has granted De Novo Classification for Biolinq Shine, the first wearable glucose biosensor to not require a needle for sensor placement, in patients with diabetes.1

Announced on September 25, 2025, by parent company Biolinq Incorporated, this approval provides a path toward scaling a new generation of wearable sensors. The product was initially developed for people with type 2 diabetes who are not insulin dependent.1

“Biolinq Shine is a first-of-its kind biosensor designed to support metabolic health for people with diabetes who are not dependent on insulin,” Dan Bradbury, Chairman of Biolinq, said in a statement. “By automatically tracking glucose levels, physical activity and sleep information, this technology offers meaningful insights that can encourage healthier choices every day.”1

Biolinq Shine will integrate glucose, activity, and sleep information in a single device with autonomous operation. A patch on the forearm collects and displays real-time glucose feedback via a primary color-coded LED display. According to Biolinq, different colors of light will indicate whether glucose has strayed from recommended levels. Additionally, the patch does not require a phone for basic functions, although sleep and activity trends are available through a separate mobile app.1

Biolinq Shine avoids the need for a subcutaneous introducer needle via a microsensor array, which is up to 20 times more shallow than conventional continuous glucose sensors. Additionally, Biolinq Shine is not filament-based.1

The American Diabetes Association (ADA) guidelines have highlighted the critical importance of time in range (TIR) for glucose levels in optimizing metabolic health. They recommend patients with diabetes stay within a target glucose range ≥70% of the time. Given the infrequency of standard glucose measurement devices, achieving this target range can prove challenging.1

The guidelines also point out the importance of data review and interpretation by both the patient and a health care professional, ensuring data are used effectively. Previous research has shown that, among patients checking their glucose levels at least once daily, a significant number report taking no action when results are high or low. Biolinq Shine’s significantly easier application and monitoring may encourage patients not only to continue consistently monitoring their blood glucose levels, but also to take action.2

“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,” Rich Yang, chief executive officer of Biolinq, said in a statement. “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.”1

References

1. Biolinq. Biolinq Shine Granted De Novo Classification by US FDA for the First Fully Autonomous, Needle-Free Glucose Sensor. GlobeNewswire. September 25, 2025. Accessed September 25, 2025. https://www.globenewswire.com/news-release/2025/09/25/3156200/0/en/Biolinq-Shine-Granted-De-Novo-Classification-by-U-S-FDA-for-the-First-Fully-Autonomous-Needle-Free-Glucose-Sensor.html

2. ElSayed NA, McCoy RG, Aleppo G, et al. 7. diabetes technology: Standards of care in diabetes—2025. Diabetes Care. 2024;48(Supplement_1). doi:10.2337/dc25-s007