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 ...

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 ...

iRhythm disclaims any intention or obligation ... Importantly, overall volume growth came not only from our Zio XT business, but also from our Zio AT business, where momentum has accelerated ...

The iRhythm Zio AT [Image courtesy of iRhythm] iRhythm Technologies (Nasdaq:IRTC) announced that the FDA granted 510(k) clearance for Zio AT design modifications and labeling updates. San ...

The increase in gross margin was primarily due to operational efficiencies as well as the absence of increased reserves for excess Zio XT printed circuit board assembly (PCBA ... for license ...

旧金山 - 数字医疗公司iRhythm Technologies, Inc. (NASDAQ:IRTC)今日宣布,美国食品和药物管理局(FDA)已批准其Zio AT设备的即将推出的升级。FDA的510(k)许可将于2025年生效,涉及旨在提高患者安全性和设备临床性能的设计修改和标签更新。 Zio AT系统包括一个可穿戴贴片、无线 ...