FDA warning letter to iRhythm for Zio AT System quality and reporting violations

iRhythm Holdings, Inc.

FDA alleges non-conformities in medical device reporting and quality system requirements for Zio AT System.
Warning letter follows August 2022 inspection of iRhythm's Cypress, CA facility; company intends to respond within specified timeframe.
Company has taken corrective measures on prior FDA Form 483 observations and will continue remediation efforts.
Warning letter does not restrict manufacturing, production, or shipment of products in U.S. or require product withdrawal at this time.
iRhythm believes no material financial impact absent further adverse FDA action, but additional regulatory actions remain possible.

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