FDA · Press announcement ·
FDA clears first OTC continuous glucose monitor for children
The FDA has cleared an over-the-counter continuous glucose monitor for children and eligible families using Dexcom’s Stelo Glucose Biosensor System.
The Food and Drug Administration (FDA) has cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM) for children: Dexcom Inc.’s Stelo Glucose Biosensor System.
A continuous glucose monitor tracks glucose levels throughout the day. This one is indicated for people two years of age and older who do not use insulin.
This matters because it expands access to glucose monitoring options that do not require a prescription, helping more families keep track of glucose over time. Use and suitability depend on the product’s indicated use.