iRhythm Technologies, Inc.

6 AI-enabled medical devices from iRhythm Technologies, Inc. on FDA's AI-enabled device list, newest first. Includes filings under name variants as submitted to FDA.

DecisionNumberDeviceCompanyPanel
2026-05-29K252859ZEUS Platform (FG0501US)iRhythm Technologies, Inc.Cardiovascular
2023-02-15K222389ZEUS SystemiRhythm Technologies, Inc.Cardiovascular
2022-07-19K213409ZEUS System (Zio Watch)iRhythm Technologies, Inc.Cardiovascular
2021-05-21K202527Zio ECG Utilization Software (ZEUS) SystemiRhythm Technologies, Inc.Cardiovascular
2019-08-23K190593Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.Cardiovascular
2018-08-29K181502Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc.Cardiovascular

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