Rhythm Technologies (Nasdaq:IRTC) announced that the FDA granted 510(k) clearance for Zio AT design modifications and ...
iRhythm Technologies has announced that the US Food and Drug Administration (FDA) has cleared design updates made to its Zio AT device. The Zio AI continuous monitoring system combines a wearable ...
iRhythm's stock surged over 20% today after the FDA cleared its 510(k) submission for the Zio AT device, despite ongoing regulatory challenges. The company still faces significant hurdles ...
The Food and Drug Administration cleared prior design modifications for iRhythm Technologies’ Zio AT wearable cardiac monitoring system in the first of two 510(k) submissions to the agency tied ...
“This clearance is related to modifications and certain enhancements to our Zio AT device previously made via letter to file and has been a priority for our teams to demonstrate iRhythm’s ...
With FDA Approval iRhythm May Be Able To Lift Regulatory Overhang, Investor Skepticism, Analyst Says
FDA clears iRhythm's first 510(k) submission for Zio AT device; second approval expected soon. Zio AT provides mobile cardiac telemetry for up to 14 days, aiding in ECG monitoring. On Monday ...
Technologies announced that the results of the Extended Ambulatory ECG Monitoring Enhances Identification of Higher-Risk ...
根据最近向美国证券交易委员会(SEC)提交的8-K文件,医疗设备和服务提供商iRhythm Technologies, Inc.对其公司治理结构进行了重大修改。这家以外科和医疗器械板块工作而闻名的公司修订了其2016年股权激励计划,并更新了行为准则。 2024年11月7日,在薪酬和人力资本管理委员会的建议下,iRhythm董事会批准了对2016年股权激励计划的修订,取消了可发行股份数量的自动年度增 ...
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