The Food and Drug Administration sent iRhythm Technologies a warning letter on 25 May alleging “non-conformities to regulations for medical devices, including medical device reporting requirements, relating to the Zio AT System and medical device quality system requirements” according to an 8-K report the company filed with the US Securities and Exchange Commission (SEC).
The FDA’s letter resulted from an inspection of the company’s facility located in Cypress, CA that concluded last August, though...