iRhythm Technologies Inc. directors and executives harmed the medical device company by concealing shortcomings in its heart monitor’s performance, including transmission issues that led to two deaths ...
The FDA issued a warning letter to iRhythm in 2023 after a facility inspection revealed issues that included failing to seek clearance before making changes to the Zio system and marketing it for a ...
iRhythm Technologies reported third-quarter revenue that exceeded consensus estimates and the company's management has narrowed its revenue guidance for 2024. The growth in volume was widespread, with ...
However, iRhythm plans to postpone the regulatory filing for its Zio MCT product until the third quarter of 2025. This delay is expected to reduce sales estimates for 2025 by approximately $10 ...
including design features and labeling updates intended to address areas of concern specific to Zio AT that were noted in a 2023 FDA warning letter to the Company,” said Quentin Blackford, iRhythm ...
SAN FRANCISCO - iRhythm Technologies, Inc. (NASDAQ:IRTC), a digital healthcare company, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Zio AT device for upcoming ...