July 6, 2025, Washington D.C. In a major win for diabetes patients and digital health innovation, the U.S. Food and Drug Administration (FDA) has granted approval for the first non-invasive, wearable glucose monitoring device. Developed by California-based startup BioSense, the device continuously measures blood sugar levels through the skin using optical spectroscopy—eliminating the need for needles or skin punctures.
The approval comes after two years of clinical trials across six U.S. hospitals and is expected to reshape how Type 1 and Type 2 diabetics manage their condition.
How the Device Works
Called the BioSense Lumino, the device resembles a sleek smartwatch and uses near-infrared sensors to measure glucose molecules diffusing through interstitial fluid beneath the skin. Data is sent in real time to a companion app, which can alert users to spikes, drops, or long-term trends.
“Our goal was to remove the barrier of pain and hassle from glucose tracking,” said Dr. Aisha Gomez, Chief Medical Officer at BioSense. “This could improve compliance rates and long-term health outcomes dramatically.”
Clinical Accuracy and Safety
In double-blind clinical trials, the Lumino achieved 91.3% accuracy compared to finger-stick glucose meters. It was also found to perform reliably across a range of skin tones and hydration levels, addressing historical concerns about wearable sensor performance.
The FDA noted that the device is cleared for use by adults 18 and older, with pediatric trials beginning later this year.
Market Availability and Insurance Coverage
BioSense says the device will begin shipping in August 2025, with a retail price of $299 and optional subscription-based data services. The company has also secured early coverage agreements with Aetna, Blue Cross, and Kaiser Permanente.
Healthcare providers expect rapid adoption among patients with insulin-dependent diabetes and those at risk for hypoglycemia.
What’s Next for BioSense
Following this approval, BioSense plans to seek CE certification for the European market and begin integration with Apple Health and Google Fit. The company also revealed early prototypes of similar sensors for measuring hydration, lactate levels, and blood pressure without cuffs or needles.
“We’re not just a medtech company. We’re building the future of invisible diagnostics,” said BioSense CEO Ravi Chopra during the company’s press event this morning.
Conclusion
The FDA’s approval of the BioSense Lumino marks a transformative shift in how glucose monitoring can be done—more comfortably, continuously, and accurately. It opens the door to a new era of medical-grade wearables that promise to improve quality of life for millions of people living with chronic conditions.
Sources: FDA Medical Devices, BioSense Official Site, MedTech Dive
