iRhythm Technologies, Inc. has agreed to a proposed $45 million settlement to resolve investor claims tied to statements about Zio AT’s data transmission, use in high-risk patients, and the accuracy of the data reported by the device.
On November 1, 2022, iRhythm cut guidance after weaker Zio AT utilization. On November 4, 2022, it disclosed a Customer Advisory Notice tied to FDA inspection issues but kept promoting Zio AT’s prospects. On May 4, 2023, the company disclosed a DOJ subpoena, and later an FDA warning letter challenged how Zio AT was marketed for high-risk patients. $IRTC fell on the news, and the case has now moved to a proposed $45 million settlement.
November 1, 2022: iRhythm revised guidance due to Zio AT utilization and lowered its growth forecast from 40% to 20%.
November 4, 2022: iRhythm disclosed a Customer Advisory Notice following FDA inspection issues and sought to reassure investors about Zio AT.
May 4, 2023: iRhythm disclosed that it had received a subpoena from the U.S. Department of Justice.
February 6, 2024: A securities class action was filed against iRhythm in the Northern District of California.
June 3, 2026: The parties entered into the settlement stipulation.
iRhythm makes cardiac-monitoring devices, including the Zio XT and Zio AT. The dispute centers on how the company described Zio AT’s transmission speed, data accuracy, and use for higher-risk patients.
On November 1, 2022, iRhythm cut guidance because Zio AT utilization was weaker than expected. Three days later, after FDA inspection issues, it issued a Customer Advisory Notice but still tried to reassure investors about Zio AT’s growth prospects.
Investors later pointed to a DOJ subpoena disclosed on May 4, 2023 and an FDA warning letter that challenged how Zio AT was marketed. They say iRhythm improperly promoted the device for patients needing real-time cardiac monitoring, even though regulators later challenged that use.
The market reaction was sharp. According to the text provided, $IRTC fell 6.09% and lost more than $227 million in market value on the warning-letter news, and the case has now moved to a proposed $45 million settlement.
What Can Investors Expect Now?
iRhythm Technologies, Inc. has agreed to a proposed $45 million settlement to resolve investor claims tied to statements about Zio AT’s data transmission, use in high-risk patients, and the accuracy of the data reported by the device.
If you were damaged due to this situation, you can file for a payout and get your share of the settlement. You can check if you are eligible and other details in the FAQ section.