Key Takeaways
·FDA found that Dexcom changed a key sensor coating without submitting a premarket notification, increasing potential risks for patients relying on CGMs for insulin dosing.
·The firm has switched from outsourcing the coating to producing it in-house.
·While Dexcom said the warning letter will not impact product approvals or financials, analysts warn that failure to fully address FDA concerns could lead to further regulatory delays.
As Dexcom works through the issues raised in a warning letter from the US FDA about quality control issues with its continuous glucose monitors, the biggest...
That device, which aims to compete with Abbott’s Libre 3 Plus, will be launched in the second half of 2025, Dexcom says.