Dexcom’s FDA Warning Letter Shows Risks Of Driving Margin As Firm Aims To Launch 15-Day Sensor
Approval ‘Not Impacted’ But Significant Work Ahead On Manufacturing Options
After switching production of coatings for its continuous glucose monitors in-house to improve supply, Dexcom ran afoul of US FDA for failing to submit a premarket notification. Firm says launch of 15-day sensor will not be delayed by the problems.
