The U.S. Food and Drug Administration (FDA) has cleared the first over-the-counter (OTC) integrated continuous glucose monitor for children. According to reporting from CNET and MedPage Today, the FDA authorization allows Stelo, the Stelo Glucose Biosensor System, to be marketed for children aged 2 years and older. The device is intended for people who do not use insulin, aligning with CNET’s description. MedPage Today also reports that the clearance covers children 2 years and older “with or without diabetes,” indicating the authorization is not limited to a single diagnosis as long as the insulin-use criteria are met. The FDA announcement is described as formal clearance for the product to be sold without a prescription. Both sources present the same core outcome: a first OTC CGM option for young children, expanding access beyond previously prescription-based continuous glucose monitoring. No additional details about the device’s accuracy, specific user workflow, or broader market impact are included in the provided excerpts.
FDA Clears First OTC Continuous Glucose Monitor for Children
The U.S. Food and Drug Administration (FDA) has cleared the first over-the-counter (OTC) integrated continuous glucose monitor for children. According to reporting from CNET and MedPage Today, the FDA...
- The FDA clears the first OTC continuous glucose monitor for children.
- The approved product is the Stelo Glucose Biosensor System.
- Marketing is authorized for children aged 2 years and older.
- The device is for people who do not use insulin.
- The clearance covers children with or without diabetes, per one report.
Stelo can now be marketed for children 2 years of age and older who do not use insulin.
2 months ago(MedPage Today) -- The FDA cleared the first over-the-counter (OTC) integrated continuous glucose monitor (CGM) for children 2 years and older with or without diabetes, the agency announced on Friday. The Stelo Glucose Biosensor System device...
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