Core Insights - iRhythm Technologies, Inc. is under investigation by Kahn Swick & Foti, LLC following a Warning Letter from the FDA regarding non-conformities related to its Zio AT System [1][2] - The company faces a securities class action lawsuit for failing to disclose material information, with the court allowing the case to proceed [3] Group 1: FDA Warning and Compliance Issues - On May 30, 2023, iRhythm disclosed receiving a Warning Letter from the FDA concerning non-conformities in medical device regulations, particularly related to the Zio AT System [2] - The FDA's concerns include deficiencies in marketing and capabilities of the Zio AT device, which may pose undisclosed risks to patients [2] Group 2: Legal Proceedings - Following the FDA warning, iRhythm and its executives were sued in a securities class action lawsuit for not disclosing material information during the Class Period [3] - The court has denied the company's motion to dismiss the lawsuit, allowing it to continue, which raises questions about potential breaches of fiduciary duties by the company's officers and directors [3]

Core Viewpoint - Kahn Swick & Foti, LLC is investigating iRhythm Technologies, Inc. following a Warning Letter from the FDA regarding non-conformities in medical device regulations and subsequent legal actions against the company and its executives [1][2][3]. Group 1: FDA Warning and Compliance Issues - On May 30, 2023, iRhythm Technologies received a Warning Letter from the FDA concerning non-conformities related to the Zio AT System, specifically addressing deficiencies in medical device reporting and quality system requirements [2]. - The FDA's concerns included undisclosed risks to patients, such as limitations in the transmission of arrhythmia or heart irregularity events [2]. Group 2: Legal Actions and Investigations - Following the FDA's Warning Letter, iRhythm and certain executives were sued in a securities class action lawsuit for failing to disclose material information, violating federal securities laws [3]. - The court has denied the company's motion to dismiss the case, allowing the lawsuit to proceed, while KSF's investigation focuses on potential breaches of fiduciary duties by iRhythm's officers and directors [3].