Dexcom made a significant design change to a component used in its sensors and did not adequately validate the change, ...

The company's response to the notice was not deemed adequate, so the FDA moved ahead with a warning letter. In a regulatory filing, Applied said that the issues raised by the regulator mainly ...

Until the issues cited in the warning letter are resolved to the FDA’s satisfaction, additional legal or regulatory action may be taken without further notice. DexCom does not expect a material ...