Biolinq Shine Receives FDA De Novo Classification as First Multi-Analyte Wearable for Type 2 Diabetes

The FDA granted de novo classification on Thursday to Biolinq Shine (Biolinq Inc), the first wearable biosensor integrating glucose, activity, and sleep information in a single device with autonomous operation.

The biosensor is marketed for individuals with type 2 diabetes (T2D) who are not dependent on insulin, aged 22 years and older. It is worn as a patch on the forearm, which provides glucose updates in real time through a color-coded LED display, as activity and sleep are monitored through a mobile app.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,” 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.”¹

How Does This Help Patients with Non-Insulin Type 2 Diabetes?

Of the more than 37 million US adults with diabetes, T2D accounts for about 90% to 95% of cases and impacts nearly 63% of individuals globally. Non-insulin-dependent T2D is characterized by hyperglycemia with resistance to ketosis, usually occurring after the age of 40. Patients with this disease often experience varying symptoms and frequently present with obesity, high blood pressure, and high lipid levels. Additionally, clinical, pathological, and biochemical evidence suggests that the condition is caused by a combined defect involving both impaired insulin secretion and insulin resistance.^2,3

The American Diabetes Association (ADA) guidelines emphasize that maintaining a good time-in-range (TIR) for glucose levels is crucial for optimizing metabolic health, recommending that individuals with diabetes aim to keep their glucose within the target range at least 70% of the time. However, reaching this goal is difficult when relying only on infrequent, episodic glucose measurements.¹

What Is Biolinq Shine’s Role in Managing Diabetes?

The Biolinq Shine sensor does not require a subcutaneous introducer needle for placement, unlike typical filament-based glucose sensors. The company noted that its microsensor array is manufactured using advanced semiconductor technology and is up to 20 times more shallow than conventional continuous glucose sensors. The sensor is offered as a simple design made for comfort and provides new levels of user engagement.¹

“As long-standing supporters and investors of Biolinq, Alpha Wave remains confident in their ability to deliver on a bold, innovative vision for biowearables,” Rick Gerson, chairman of Alpha Wave Global, said. “Biolinq is on the path to redefine how society thinks about cardiometabolic health and wellness, driving the next wave of innovation with a profound multi-analyte biosensor platform.”¹

Through the LED lights, individuals can determine glucose excursions in real time. If a blue light appears on the sensor, it indicates target range, and yellow indicates above range, or high glucose. While the qualitative display shows real-time glucose changes, the accompanying app provides more detailed glucose information, which correlates with meals, rest, and activity levels.^1,4

The company noted in a press release that this information will help users make immediate behavioral and lifestyle changes, but interpretation of the readings should focus on trends and patterns, and users should not take medical action without consulting with a health care provider.⁴

“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, CEO of Biolinq, said. “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. Bioling Shine™ Granted De Novo Classification by U.S. FDA for the First Fully Autonomous, Needle-Free Glucose Sensor. Biolinq. News release. September 25, 2025. Accessed September 26, 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. Cleveland Clinic. Type 2 Diabetes. News release. Updated November 8, 2023. Accessed September 26, 2025. https://my.clevelandclinic.org/health/diseases/21501-type-2-diabetes

3. Rodger W. Non-insulin-dependent (type II) diabetes mellitus. CMAJ. 1991 Dec 15;145(12):1571-81. PMID: 1742694; PMCID: PMC1336077.

4. Bioling. The first fully autonomous, needle-free glucose sensor. Accessed September 26, 2025. https://www.biolinq.com/