FDA clears Dexcom's Stelo as first OTC continuous glucose monitor for children
The U.S. Food and Drug Administration cleared Dexcom's Stelo Glucose Biosensor System for over-the-counter use in children two years of age and older who do not use insulin.
This is the first OTC continuous glucose monitor authorized for pediatric use, building on an earlier clearance for adults in March 2024.
Regulators noted the rise of prediabetes among U.S. children and said real-time glucose data can help families monitor diet, exercise and medication to improve long-term health outcomes.
The device is intended for children who manage diabetes with oral medication or who simply want to track glucose trends, providing a new tool for caregivers and clinicians.
This writeup was produced by pharmadog from original reporting by fda press.
Original headline: “FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children”
read at fda press ↗
comments(0)
5-min edit window · permanent after that