FDA has found iRhythm Technologies to be out of sync with certain medical device regulations, according to a warning letter the company disclosed last week in an SEC filing.
The warning letter stems from an FDA inspection of the company's Cypress, CA facility that concluded in August 2022. The letter alleges nonconformities to regulations, including medical device reporting requirements, relating to iRythm's Zio AT System and medical device quality system requirements.
In the SEC filing, iRhythm said it intends to respond within the specified time period and work to address FDA's concerns. The company said it has already taken measures to address certain observations FDA previously identified from its 2022 inspection.
The warning letter does not directly restrict the manufacture, production, or shipment of any of iRhythm's products in the United States or require the withdrawal of any product from the U.S. marketplace. iRhythm said it does not currently expect the warning letter to have a material impact on its financial results.
The warning letter follows the company's earlier disclosure of receipt of a subpoena from the consumer protection branch of the civil division at the Deptartment of Justice. Boston Scientific disclosed a similar subpoena related to its ambulatory ECG monitoring business.
"We view it as a positive that this seems to be related to the industry and is not [iRhythm-specific]," Marie Thibault, a medtech analyst at BTIG, wrote in a May 4 report, following iRhythm's earnings call. "...We do not see any reason to panic at this point, but acknowledge that this is unsettling and that it may be a small overhang on the stock."
