Dexcom Gains FDA Clearance for 15-Day G7 Glucose Monitor

Dexcom has received FDA clearance for a 15-day version of its G7 continuous glucose monitor (CGM), extending its wear time beyond the previous 10-day model. This approval comes as a relief to investors concerned about potential delays following a recent FDA warning letter, which ultimately did not hinder the regulatory process.

The updated G7 sensor, now with a 15.5-day wear time, is positioned to boost Dexcom’s competitive edge against Abbott’s Freestyle Libre 3, which also received 15-day clearance in 2023. Dexcom reports a mean absolute relative difference (MARD) of 8%, closely trailing Abbott’s 7.9%, a key indicator of CGM accuracy.

Executives expect the longer wear period to improve profit margins and anticipate a full launch in the second half of 2025, allowing time for integration with insulin pumps. Analysts see greater financial impact by 2026, with Dexcom targeting $4.6 billion in revenue for 2025.

20-04-2025