Dive Brief:
- Dexcom received Food and Drug Administration clearance for a 15-day version of its G7 glucose sensor, the company announced Thursday.
- Dexcom claims its continuous glucose monitor is the most accurate and has the longest wear time. The company also expects the shift from a 10-day to a 15-day sensor to improve its margins, executives said in a February earnings call.
- The announcement alleviated investor concerns that a recent FDA warning letter might delay the decision. Dexcom expects a full launch in the second half of 2025, giving the company time to integrate the updated device with insulin pumps.
Dive Insight:
The new sensor’s longer wear time should give Dexcom a boost against competitor Abbott, analysts wrote.
Dexcom’s G7 sensor was cleared for a 15.5-day wear time. Abbott received clearance in 2023 for an update to its Freestyle Libre 3 sensors, giving them a wear time of up to 15 days.
Dexcom also said its device has a mean absolute relative difference of 8%. Meanwhile, Abbott’s Libre 3 has a MARD of 7.9%. The accuracy measurement compares CGM readings to blood glucose values and is a standard performance metric for glucose sensors.
Dexcom has also been catching up with Abbott in price, RBC Capital Markets analyst Shagun Singh wrote in a Thursday research note. Citing meetings with physicians in March and April, Singh said Dexcom is getting more affordable, and the company “is increasingly matching up to [Abbott]” on the cost to people with Type 2 diabetes.
The shift from a 10-day to a 15-day wear time is expected to help Dexcom’s margins. J.P. Morgan analyst Robbie Marcus expects little change in 2025 due to the launch timing, but more of a benefit in 2026.
The news was a relief for investors after concerns that the warning letter Dexcom received in March could affect the timing for a 15-day sensor. Dexcom Chief Operating Officer Jake Leach told MedTech Dive that the letter does not preclude the company from getting new products approved.
Despite these assurances, Leerink Partners analyst Mike Kratky wrote that investors had been more cautious, and the FDA clearance is an “incremental positive.”
Dexcom has forecast total revenue of $4.6 billion for 2025.
