iRhythm Technologies Receives FDA 510(k) Clearance for Design Updates Previously Made to Its Zio® AT Device

Core Insights - iRhythm Technologies, Inc. has received FDA clearance for modifications to its Zio AT device, affirming its commitment to quality and compliance [1][2] - The Zio AT device is a mobile cardiac telemetry system designed for long-term monitoring of cardiac events, with a focus on patient safety and physician trust [2][5] Company Overview - iRhythm is a digital health care company that combines wearable biosensors and cloud-based analytics to provide actionable cardiac health information [4] - The company aims to enhance patient care through its innovative Zio product portfolio [4] Product Details - The Zio AT device records ECG data for up to 14 days and transmits it via a wireless gateway to the Zio ECG Utilization Software (ZEUS) for analysis [2] - The device has demonstrated a 98% patient compliance rate, attributed to its user-friendly design that requires no patient manipulation [3] Clinical Performance - The effectiveness of the Zio service is supported by over 100 scientific research manuscripts, highlighting its reliability and accuracy [3] - Physicians agree with the comprehensive end-of-wear report provided by the Zio service 99% of the time, indicating high trust in its clinical performance [3]