IRhythm Receives FDA Warning Letter After Inspection

IRhythm Technologies says it received a warning letter from the US Food & Drug Administration May 25.

• Letter results from inspection of the company’s facility in Cypress, Calif., that concluded in Aug. 2022
• Letter alleges non-conformities to regulations for medical devices, including medical device reporting requirements, relating to the company’s Zio AT System and medical device quality system requirements
• IRhythm “takes these matters very seriously,” will “work diligently to address the FDA’s concerns”
• Warning letter doesn’t directly restrict manufacture, production or shipment of products in the US or require withdrawal of any product
• “At this time, the Company believes that ...