iRhythm Launches Zio® Long-Term Continuous Monitoring Service in Japan as the Zio® ECG Recording and Analysis System, Advancing AI-Powered Arrhythmia Detection

Core Viewpoint - iRhythm Technologies has launched its Zio long-term continuous ECG monitoring system in Japan, offering up to 14 days of uninterrupted ECG monitoring, which is a significant improvement over existing options in the market [1][4]. Company Overview - iRhythm Technologies, Inc. is a leading digital health care company focused on creating solutions that detect, predict, and prevent disease through wearable biosensors and cloud-based data analytics [14]. - The company has a strong commitment to improving patient outcomes, supported by over 125 original research manuscripts and insights from more than 2 billion hours of curated heartbeat data [7]. Product Details - The Zio ECG Recording and Analysis System includes a patch-based ECG monitoring device that can be worn for up to 14 days and utilizes a deep-learned AI algorithm approved by Japan's Pharmaceuticals and Medical Devices Agency (PMDA) [3][5]. - The system demonstrates 99% patient compliance with prescribed wear time and 99% analyzable data, providing high-quality, actionable insights [5]. - The Zio service is associated with the highest diagnostic yield and lowest likelihood of retesting compared to other monitoring services, including Holter monitoring [5]. Market Opportunity - Japan is the second largest ambulatory cardiac monitoring market globally, with an estimated 1.6 million tests prescribed annually, a number expected to rise due to the aging population and increasing prevalence of cardiac arrhythmias [10][11]. - The launch of the Zio system is timely, addressing the growing demand for early and accurate detection of arrhythmias in Japan [4]. Clinical Validation - The clinical value of the Zio LTCM service has been validated through studies, including the CAMELOT study, which found it to be associated with the highest yield of specified arrhythmia diagnosis and the lowest likelihood of repeat testing [6][8]. - The Zio service combines advanced AI with expert clinical review to support accurate and timely diagnoses, enhancing patient care [8]. Distribution and Availability - The Zio ECG Recording and Analysis System will be available to healthcare customers in Japan starting May 2025, with nationwide availability expected by July 2025, through Senko Medical Instrument, the exclusive distribution partner [12].