We’re thrilled to celebrate another major regulatory milestone for Biolinq, an EvoNexus graduate. On September 24, 2026, the San Diego company announced that the U.S. Food and Drug Administration has granted 510(k) clearance for over-the-counter use of Biolinq Shine, its needle-free glucose sensor. Adults can now access Biolinq Shine without a prescription, just one year after the device earned its landmark FDA De Novo classification.
“Like most startups coming to EvoNexus, this company began as two founders, Dr. Josh Windmiller, and Dr. Jared Tangney, recent PhD graduates of the University of California, San Diego. The development of their technology took years to accomplish. Deep science always does,” Said Rory Moore, CEO and Co-Founder of EvoNexus. “During the years that followed the founding of the company, significant venture capital was secured, an additional technologist recruited, and an accomplished industry veteran, Rich Yang, became CEO.”
It is a meaningful shift in who this technology can reach. Continuous glucose insight is no longer something people need to request from a doctor. With this clearance, Biolinq Shine moves from the clinic into everyday life.
From De Novo to Over-the-Counter
In September 2025, the FDA granted Biolinq Shine De Novo classification, creating an entirely new category for autonomous wearable biosensors. That decision opened Biolinq’s path to market. The new 510(k) clearance widens it, allowing the company to offer Biolinq Shine directly to consumers.
“This clearance represents an important evolution in how people can access glucose information to build greater awareness of their metabolic health,” said Amy VandenBerg, Chief Regulatory and Clinical Officer at Biolinq. She added that the FDA conducted a thorough and rapid review of the company’s submission.
How Biolinq Shine Works
Most continuous glucose monitors rely on a filament placed beneath the skin with an introducer needle. Biolinq Shine takes a different route. Its microsensors are built using semiconductor manufacturing techniques and sit close to the skin’s surface, so no needle is required to place the sensor.
Worn on the forearm, the patch is the first glucose sensor with an integrated primary display that works with or without a phone. A color-coded LED signals in real time whether glucose is within, above, or below the target range. Biolinq Shine also tracks activity and sleep, and an optional companion app shows how meals, movement, and rest shape glucose levels over time.
Who Biolinq Shine Is For
Biolinq Shine is intended for adults ages 22 and older who are not on insulin. It provides glucose range information to support general awareness of patterns and trends. It is not designed to deliver exact glucose values for acute medical decisions such as insulin dosing or medication adjustments.
That focus on everyday awareness is central to the company’s vision. “By making Biolinq Shine available without a prescription, we can help more people understand how daily choices affect metabolic health and inspire a broader shift toward continuous biosensing as a foundation for healthier living,” said Rich Yang, Chief Executive Officer of Biolinq.
An EvoNexus Success Story, One Milestone at a Time
Biolinq’s journey is one we have been proud to follow from the start. The company closed a $10 million Series A in 2017, raised $58 million in 2024 to advance its pivotal trial, closed a $100 million Series C in April 2025, and secured De Novo classification that September. Today’s clearance builds on every one of those steps, turning years of research and clinical work into a product people can access without a prescription.
Congratulations to Rich Yang and the entire Biolinq team on this achievement.
About Biolinq:
Biolinq Incorporated is a San Diego healthcare technology company developing precision multi-analyte wearable biosensors to improve metabolic health. Its microsensors sit just below the skin’s surface, powering a simple, needle-free approach to continuous biosensing designed to support healthier living. Learn more here.
About EvoNexus:
EvoNexus is California’s leading nonprofit technology startup incubator, with locations in San Diego and Irvine. Since its formation in 2010, EvoNexus has successfully built 290 companies with an exceptional survival rate of over 85%, with portfolio companies securing over $2.4B in cumulative venture funding, backed by a network of more than 400 venture capital and independent investors, and achieving 63 acquisitions alongside a successful IPO, with additional public market exits on the horizon and over $6 billion in pre-exit valuations. Backed by an elite network of global corporate partners, including Irvine Company, Qualcomm, AMD, BAE Systems, Viasat, ResMed, LG, Murata Manufacturing, and EMD Electronics, EvoNexus continues to drive massive economic impact across Southern California’s innovation economy, culminating in a record-breaking year with $619M raised for the portfolio in 2025 alone.