FDA Approves Dexcom's Stelo As First Glucose Monitoring Device Without Prescription
Portfolio Pulse from Vandana Singh
The FDA has approved DexCom Inc's Stelo Glucose Biosensor System as the first over-the-counter continuous glucose monitor (CGM) for individuals 18 and older who do not use insulin. The device, which pairs with a smartphone app to display glucose values, will be available online without a prescription starting summer of 2024. This approval could expand access to CGM technology for the 25 million people in the U.S. with Type 2 diabetes who do not use insulin. Following the announcement, DexCom's shares rose by 2.64% in premarket trading.
March 06, 2024 | 2:13 pm
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DexCom Inc's Stelo Glucose Biosensor System received FDA approval as the first over-the-counter CGM, available online without a prescription starting summer of 2024. This approval could significantly increase the user base among the 25 million people in the U.S. with Type 2 diabetes who do not use insulin. DexCom's shares increased by 2.64% in premarket trading following the announcement.
The FDA approval of DexCom's Stelo as the first over-the-counter CGM is a significant milestone for the company, potentially expanding its market significantly among non-insulin-dependent Type 2 diabetes patients. The positive premarket stock movement reflects investor optimism about the product's impact on DexCom's market position and future revenue growth.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100