After raising $100 million in venture capital funding earlier this year, Biolinq has obtained a groundbreaking green light from the FDA for its needle-free continuous glucose monitor.
The Shine system, which also tracks activity and sleep data, will initially be targeted at individuals with Type 2 diabetes. The reader employs microsensors placed in the topmost layers of the skin, which the company describes as being up to 20 times shallower than filament-based CGMs that require a subcutaneous introducer during placement and setup.
Biolinq also bills its sensor as virtually painless and autonomous, with the coin-sized forearm patch providing real-time feedback on glucose levels via its own color-coded LED display, allowing it to be used without a paired smartphone app.
The agency’s de novo clearance pitches the Shine sensor as providing a more qualitative view of the user’s glucose ranges and trends—not as a CGM that supplies the quantitative measurements used to calculate insulin doses.
“Biolinq Shine is a first-of-its-kind biosensor designed to support metabolic health for people with diabetes who are not dependent on insulin,” Biolinq Chairman Dan Bradbury 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.”
“The entire Biolinq team is thrilled about this regulatory milestone, which is a testament to the outstanding work by our team,” added CEO Rich Yang. “We are grateful to the FDA for its rapid and rigorous review in establishing a new category of wearable biosensors.”
In April, the San Diego-based company announced a $100 million series C round, stating that it would help launch its commercialization plans. Biolinq has also been developing an electrochemical microsensor array that tracks lactate and ketone levels, in addition to glucose monitoring—however, the initial FDA clearance only covers glucose monitoring.
“As long-standing supporters and investors of Biolinq, Alpha Wave remains confident in their ability to deliver on a bold, innovative vision for biowearables,” said Rick Gerson, chairman of Alpha Wave Global, which led the company’s series C as well as a $58 million round in 2024. “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.”