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iRhythm Technologies, Inc. FDA Approvals
0 new drug approvals and 8 device clearances on file. Matched by name to IRTC.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| ZEUS Platform (FG0501US)510(k)May 29, 2026Cardiovascular |
| Zio® monitor (DFG0001)510(k)Aug 15, 2025Cardiovascular |
| Zio AT® device (A100A1001)510(k)Oct 30, 2024Cardiovascular |
| Zio AT® device (A100A1001)510(k)Oct 21, 2024Cardiovascular |
| ZEUS System510(k)Feb 15, 2023Cardiovascular |
| ZEUS System (Zio Watch)510(k)Jul 19, 2022Cardiovascular |
| Zio Monitor510(k)May 21, 2021Cardiovascular |
| Zio ECG Utilization Software (ZEUS) System510(k)May 21, 2021Cardiovascular |