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"FDA Clears Dexcom's Stelo as First Over-the-Counter Continuous Glucose Monitor"

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Source: FDA.gov
"FDA Clears Dexcom's Stelo as First Over-the-Counter Continuous Glucose Monitor"
Photo: FDA.gov
TL;DR Summary

The FDA has approved the first over-the-counter continuous glucose monitor, the Dexcom Stelo Glucose Biosensor System, designed for individuals 18 years and older who do not use insulin. This integrated CGM allows users to monitor and analyze glucose levels using a wearable sensor and a smartphone app, providing valuable information about their health without the involvement of a healthcare provider. However, it is not intended for individuals with problematic hypoglycemia. This approval aligns with the FDA's goal of advancing health equity by expanding access to valuable health information for all patients.

Topics:business#continuous-glucose-monitor#dexcom-stelo#fda#health-equity#health-tech#over-the-counter
Share this article
  1. FDA Clears First Over-the-Counter Continuous Glucose Monitor  FDA.gov
  2. Dexcom announces its first-ever over-the-counter CGM Stelo has been cleared by the FDA  CNBC
  3. Stelo by Dexcom First Glucose Biosensor to be Cleared by FDA as Over-the-Counter  Business Wire
  4. First over-the-counter continuous glucose monitor OK'd by FDA  STAT
  5. US FDA Clears Use of First Over-The-Counter Continuous Glucose Monitor  U.S. News & World Report

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