Dexcom nets FDA clearance for 15-day CGM

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Dexcom has secured FDA clearance for a 15-day version of its G7 continuous glucose monitor (CGM), marking a key milestone that extends the device’s wear time from 10 to 15 days. The update, which claims the highest accuracy and longest wear time among CGMs, is expected to launch fully in the second half of 2025. Analysts see this as a strategic move to enhance Dexcom’s competitive standing against Abbott, which received similar approval for its Freestyle Libre 3 sensors in 2023. RBC Capital Markets analyst Shagun Singh and others noted that the longer wear time could improve Dexcom’s profit margins and close gaps in pricing for people with Type 2 diabetes.

The clearance also eased investor concerns after Dexcom received an FDA warning letter in March that some feared might delay new approvals. Executives, however, emphasized that the letter did not affect their ability to launch new products. Dexcom highlighted the G7’s mean absolute relative difference (MARD) of 8%, slightly above Abbott’s 7.9%, reinforcing its position in the accuracy race. While the 2025 financial impact may be modest due to the mid-year rollout, analysts like J.P. Morgan’s Robbie Marcus predict more significant margin benefits in 2026. With a forecasted revenue of $4.6 billion for 2025, Dexcom is poised to grow as it continues evolving its CGM offerings.