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).
Facility Inspection Leads To FDA Warning For iRhythm
The US FDA issued a warning letter to iRhythm Technologies related to its Zio cardiac monitor system after an August 2022 inspection of the firm’s California facility. Wells Fargo predicts little impact on the company.
