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IRTC.US
id: 1047, Created by , Scout

iRhythm (IRTC) Zio AT FDA Warning Letter Case

N.D. California
Court
3:24-cv-00706
Case number
11 Jan 2022
Class period Start
30 May 2023
Class period End
  • $IRTC stockholder filed a claim vs. iRhythm for misrepresenting Zio AT prospects and falsely marketing it.
  • The news about the Zio AT and the FDA letter caused $IRTC to fall 6% and lose over $227M of shareholder value.
On November 1, 2022, iRhythm Technologies revised its guidance due to "Zio AT utilization," lowering its growth forecast from 40% to 20%.

Three days later, on November 4, 2022, iRhythm disclosed issuing a Customer Advisory Notice following FDA inspection issues. Despite this, iRhythm sought to reassure investors and promoted Zio AT growth.

On May 4, 2023, iRhythm disclosed receiving a subpoena from the U.S. DOJ. Later, iRhythm received an FDA warning letter regarding the marketing of the Zio AT device. The FDA highlighted that iRhythm falsely marketed Zio AT for high-risk patients needing real-time cardiac monitoring, contrary to its approved use.

On this news, $IRTC fell 6.09% and lost over $227M of its market capitalization, seriously damaging shareholders.

Based on these events, $IRTC stockholder filed a claim against iRhythm and its leaders, accusing them of the following:
  • iRhythm repeatedly promoted Zio AT's growth potential in the market for real-time monitoring, which investors viewed positively due to the premium price for devices.
Considering all the information, investors suspect iRhythm of violating federal regulations, which led to their losses.
Alleged Offence
Misleading Statements
Failure to Disclose
Omissions
Suspected Party
Directors
Management
Security Type
Stocks
Trade Direction
Long
Shock Event Date
31 May 2023
Filing date
06 February 2024
Lead Plaintiff Deadline
08 April 2024
Collecting participants…

iRhythm Technologies Inc

iRhythm Technologies, Inc., a digital healthcare company, provides ambulatory electrocardiogram (ECG) monitoring products for patients at risk for arrhythmias in the United States. It offers Zio se...

    Ticker
    IRTC.US
    ISIN
    US4500561067
    CIK
    1388658
    Sector
    Healthcare
    Industry
    Medical Devices
    Country
    USA
    Address
    699 8th Street, San Francisco, CA, United States, 94103