Lexology March 28, 2024
McDermott Will & Emery

On March 5, 2024, the US Food and Drug Administration (FDA) granted clearance to market the first over-the-counter (OTC) continuous glucose monitor (CGM). Dexcom’s Stelo Glucose Biosensor System (Stelo) is an integrated CGM (iCGM) designed for individuals 18 years and older who do not use insulin. Previously, CGMs were only available by prescription and were primarily designed for diabetes management. However, CGMs may offer a new avenue for wellness, proactive health monitoring and accessibility to chronic care management – all without a prescription.

In Depth

UNDERLYING TECHNOLOGY

A Brief History of CGMs

A CGM is a wearable technology that enables users to track their blood sugar levels in real time. Historically, individuals with Type 1 or Type 2 diabetes could...

Today's Sponsors

LEK
ZeOmega

Today's Sponsor

LEK

 
Topics: Digital Health, FDA, Govt Agencies, Medical Devices, Technology, Wearables
Apple gets FDA okay to use AFib tool in clinical trials
Lab test overhaul: FDA to regulate LDTs as medical devices
Project Optimus: helping or hindering cancer drug development?
Cancer screenings, menthols and the moonshot
The Time Is Now For Federal Reform Of Direct-To-Consumer Advertising Of Prescription Drugs

Share This Article