Last week, the FDA gave 510(K) clearance to the first needle-free wearable, Biolinq Shine, that can track glucose, sleep and activity all in a single device. This builds on Biolinq’s De Novo classification from the FDA last fall, which established a new regulatory category for wearable, needle-free metabolic biosensors.
What does FDA 510(k) clearance mean?
Similar to FDA approval, an FDA 510(K) clearance applies to moderate-risk (class II) medical devices that are not life-sustaining. This clearance gives the green light on the Biolinq Shine, meaning it is safe and effective for wide-scale use.
Available without a prescription, this expands access to key components of metabolic health that can improve not only glucose levels but overall well-being for millions of people, including people living with prediabetes or type 2 diabetes who don’t use insulin.
“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. “The FDA conducted a thorough and rapid review of our submission, and we appreciate the agency’s rigor and engagement throughout the process.”
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