The Zio AT wireless patch device is cleared by the FDA for continuous monitoring of heart rhythms in non-critical care patients during daily activities, where real-time monitoring is not needed. Data is reported to the patient’s healthcare team to help physicians diagnose arrhythmias.

According to the FDA’s May 2023 warning letter, iRhythm began marketing Zio AT as a mobile cardiac telemetry monitor intended for “near real-time monitoring” of high-risk patients. The changes required new 510(k) submissions.

In its announcement, iRhythm said Zio AT and the Zio ECG Utilization Software enable ambulatory mobile cardiac telemetry monitoring service for non-critical care patients.