On November 27, 2024, the company announced it had received a Complete Response Letter (CRL) from FDA for its NDA, and shortly thereafter it received a Warning Letter, which the company disclosed ...

The FDA issued a warning letter to iRhythm in 2023 after a facility inspection revealed issues that included failing to seek clearance before making changes to the Zio system and marketing it for ...

Discover industry-tested approaches to strengthen quality systems and navigate regulatory scrutiny in this comprehensive ...

according to the warning letter. Dexcom has ceased distribution of G7 sensors with the component, but the company’s response did not address affected G6 sensors. J.P. Morgan analyst Robbie ...

DexCom received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz. facilities and is working on a written response. The diabetes devices ...