Company profile

iRhythm Technologies, Inc.

iRhythm Technologies, Inc. has 6 AI-enabled medical devices on the FDA list. The first decision was on August 29, 2018 and the most recent on May 29, 2026 (ZEUS Platform (FG0501US)). Its most common review panel is Cardiovascular (6 devices).

6AI devices

2018First decision

2026Latest decision

1Specialties

Per year

201820192021202220232026

iRhythm Technologies, Inc. AI devices per year: 2018 1, 2019 1, 2021 1, 2022 1, 2023 1, 2026 1

By specialty

Cardiovascular6

Related guides

Top cardiovascular devices

Timeline

May 29, 2026 · 510(k) K252859ZEUS Platform (FG0501US) · Cardiovascular · DQK
February 15, 2023 · 510(k) K222389ZEUS System · Cardiovascular · DQK
July 19, 2022 · 510(k) K213409ZEUS System (Zio Watch) · Cardiovascular · DQK
May 21, 2021 · 510(k) K202527Zio ECG Utilization Software (ZEUS) System · Cardiovascular · DQK
August 23, 2019 · 510(k) K190593Zio XT ECG Monitoring System, Zio AT ECG Monitoring System · Cardiovascular · DQK
August 29, 2018 · 510(k) K181502Zio AT ECG Monitoring System, ZEUS System · Cardiovascular · DQK