i Rhythm Technology得到FDA 510(k)许可,用于更新Zio AT设备,处理2023年警告函问题。 iRhythm Technologies receives FDA 510(k) clearance for updated Zio AT device addressing 2023 warning letter concerns.
i Rhythm Technologies收到FDA 510(k)号许可,用于增强定于2025年发射的Zio AT装置,以解决2023年一封警告函中的关切。 iRhythm Technologies received FDA 510(k) clearance for enhancements to its Zio AT device, set to launch in 2025, addressing concerns from a 2023 warning letter. Zio AT为非关键病人提供移动心脏遥测,并声称遵守率很高。 The Zio AT offers mobile cardiac telemetry for non-critical patients and boasts high compliance rates. 在Q3 2024年,iRhythm报告收入增长18%,达到1.475亿美元,总差值为68.8%。 In Q3 2024, iRhythm reported an 18% revenue increase to $147.5 million, with a gross margin of 68.8%. 该公司在国际上扩大,并与BioIntellisense公司签订了技术许可证协议。 The company expanded internationally and entered a tech licensing agreement with BioIntelliSense.