top of page
iRhythm Probed By Federal Watchdog In Charge of Patient Safety
Federal subpoena requires medical device firm to provide documents to judge in person.
May 11, 2023
One month prior to filing its latest quarterly report iRythm Technologies (IRTC), a maker of ambulatory electrocardiogram (ECG) monitoring products for people with arrhythmias, revealed its products and services are being investigated by the federal division tasked with protecting the public’s health, safety, economic security, and identity integrity.
iRythm received a type of federal subpoena requiring the company to testify about its products in person. The Subpoena Duces Tecum— received April 4th— requires iRythm, according to attorneys, to “produce books, documents or other records under his or her control at a specified time/place in a court hearing or a deposition.”
The subpoena is from the Consumer Protection Branch, Civil Division of the U.S. Department of Justice and requests iRhythm produce:
“...various documents regarding our products and services.”
iRhythm provided no additional detail regarding the types of questions the DOJ is asking and disclosed it’s not able to predict the eventual scope of the investigation.
Separately, iRhythm is no stranger to heightened scrutiny. The company misstated revenue and other accounts resulting in financial restatements for the years 2017-2019. The company also disclosed multiple control deficiencies in 2020 and 2021.
Shares are up 36% ytd.
Become a DuDil Insider
Get our due diligence alerts before they're released publicly & be first to know.
bottom of page