iRhythm’s Zio ECG Monitoring System Wins Japanese Regulatory Approval

Japan’s Pharmaceutical and Medical Device Agency (PMDA) has approved iRhythm Technologies Inc.’s Zio 14-day, long-term continuous ECG monitoring system. The company is now working to attain reimbursement for the product. 
 
The Zio long-term continuous monitoring (LTCM) service consists of a prescription only patch ECG monitoring device (Zio monitor) worn for up to 14 days and the ZEUS (Zio ECG Utilization Software) System (iRhythm’s advanced artificial intelligence algorithm) that generates a comprehensive end-of-wear report reviewed and curated by certified cardiographic technicians. The Zio system represents a significant advancement in cardiac arrhythmia diagnostics compared to traditional Holter monitoring⁴ and is designed to deliver high clinical accuracy to help doctors make the right diagnosis the first time. iRhythm’s deep learning approach can classify a broad range of distinct arrhythmias with high diagnostic performance similar to that of cardiologists and, in clinical settings, this service could reduce the amount of misdiagnosed computerized ECG interpretations and improve clinical efficiency.⁵
 
“With the strong support from our partners at the Japanese Heart Rhythm Society, we are thrilled to receive this approval from the Japanese PMDA as a testament to iRhythm’s commitment to innovation and the highest standards of quality and performance,” iRhythm Technologies President/CEO Quentin Blackford said. “We are very grateful for their diligent review of our Shonin application as we seek to drive better health outcomes and more equitable access for patients around the globe. We look forward to continuing working closely with the MHLW [Ministry of Health, Labour, and Welfare] during their market access and reimbursement review of the Zio service.”
 
The Zio system was previously designated for high medical needs by the MHLW, a rarely bestowed distinction in Japan that is granted to innovative devices recognized as having high medical utility for significant diseases. The Zio system was indicated for this designation at the recommendation of the JHRS based on the clinical improvements that the Zio services provide compared to traditional Holter monitoring^4,5 and the significant need that patients in Japan face to improve detection of potential cardiac arrhythmias.

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READ MORE: iRhythm Collaborates With Epic to Streamline Zio Service Access

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Japan is the second largest ambulatory cardiac monitoring market in the world with an estimated 1.6 million tests prescribed annually¹—a number that is expected to continue to increase based on stroke and cardiovascular disease burden in an aging population.^2,3 However, Japanese patients are forced to use Holter monitoring, the traditional standard of care, because patch-based technology like the Zio service has not been adopted.
 
Since the company’s inception, iRhythm has posted more than 8 million patient reports and amassed a repository of approximately 1.8 billion hours of curated ECG data.⁷ Zio monitor, Zio XT, and Zio AT (mobile cardiac telemetry) systems are currently available in the United States, and Zio XT system is available in the United Kingdom. Additionally, iRhythm recently announced the commercial launch of Zio monitor in Austria, the Netherlands, Spain, and Switzerland. iRhythm has signed a letter of intent with a distribution partner in Japan and is actively collaborating with that partner to prepare for market launch once reimbursement is approved by the MHLW.
 
iRhythm is a digital healthcare company that creates solutions for detecting, predicting, and preventing disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health.

References 
¹ Irie S, Tada H. The Relationship between Holter Electrocardiography and Atrial Fibrillation Diagnosis Using Real-World Data in Japan. Int Heart J. 2023;64(2):178-187.
² Matsuda S. Health Policy in Japan – Current Situation and Future Challenges. JMA Journal, 2019.
³ Annual Pharmaceutical Production Statistics, Ministry of Health, Labour, and Welfare (“MHLW”).
⁴ Barrett P. et al. Comparison of 24-hour Holter monitoring vs. 14-day novel adhesive patch electrocardiographic monitoring. American Heart Journal of Medicine, 2014.
⁵ Hannun, AY. et al. Cardiologist-level arrhythmia detection and classification in ambulatory electrocardiograms using a deep neural network. Nature Medicine, 2019.
⁶ Turakhia, M. et al. Diagnostic Utility of a Novel Leadless Arrhythmia Monitoring Device, American Journal of Cardiology, 2013.
⁷ Data on file. iRhythm Technologies, 2024.