Dexcom Submits 15-Day G7 CGM to FDA, Aims to Match Stelo Biosensor Wear Time
核心洞察
Dexcom (搜索) has submitted a 15-day version of its G7 (搜索) continuous glucose monitor (CGM) to the FDA, potentially extending its wear time by 50%.
The submission aims to align the G7 (搜索)'s wear time with Dexcom (搜索)'s recently launched Stelo biosensor (搜索), which already features a 15-day wear time.
Dexcom (搜索)'s third-quarter earnings report also exceeded consensus forecasts, reflecting continued growth and innovation in glucose monitoring technology.
Dexcom (搜索) has announced the submission of its 15-day G7 (搜索) continuous glucose monitor (CGM) to the FDA. This submission marks a significant advancement for the company, potentially extending the wear time of its flagship CGM from 10 to 15 days, matching the duration of its Stelo biosensor (搜索), which was developed on the G7 platform.
The San Diego-based company's move aims to provide users with greater convenience and reduce the frequency of sensor replacements. The extended wear time could improve adherence and lower the overall cost of CGM therapy for patients with diabetes (搜索).
The announcement coincided with Dexcom (搜索)'s third-quarter earnings report, which surpassed consensus forecasts. Shares of DXCM saw a slight increase at the opening of trading following the report.
Dexcom (搜索)'s Stelo Glucose Biosensor System Receives FDA Clearance
In other news, Dexcom (搜索) recently received FDA clearance for its Stelo Glucose Biosensor System, the first over-the-counter (OTC) continuous glucose monitor (CGM) indicated for use by people ages 18 years and older who are not on insulin. The Stelo system is designed to help users gain insights into how their body responds to food and exercise and does not require a prescription.