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# FDA Clears Design Changes to Zio AT
- URL: https://www.fdaweb.com/fda-clears-design-changes-to-zio-at/
- Published: 2024-10-21T12:00:00.000Z
- Updated: 2026-09-14T14:44:29.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158021

FDA has cleared an iRhythm Technologies 510(k) related to prior design changes made to the Zio AT device under a letter to file. A 5/25/2023 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/irhythm-technologies-inc-643474-05252023?ref=fdaweb.com) noted that the device was cleared for long-term monitoring of arrhythmia events for non-critical care patients where real-time monitoring is not needed as reporting timeliness is not consistent with life-threatening arrhythmias. Marketing materials, the letter said, described different indications with changes to the device that would require a new 510(k) submission. The latest 510(k) clearance addressed those changes.

The prescription-only outpatient cardiac telemetry device includes the Zio AT patch, an ECG monitor that continuously records ECG data for up to 14 days, according to the company. It also features a wireless gateway that provides connectivity between the patch and the Zio ECG utilization software to transmit data during the wear period, and the company’s “deep-learning algorithm” that analyzes cardiac events transmitted by the patch device and gateway, it says.

“The Zio AT services provide event transmission reports during wear and a comprehensive end-of-wear report with preliminary findings to the treating medical professional for final clinical decisions,” iRhythm says.