iRhythm Technologies, Inc. (NASDAQ:IRTC), a leading digital health care company focused on creating trusted solutions that detect, predict, and prevent disease, announced today that it has received regulatory approval from the Japanese Pharmaceutical and Medical Device Agency (PMDA) for the Zio® fourteen-day, long-term continuous ECG monitoring system.

iRhythm Technologies，Inc.（纳斯达克股票代码：IRTC）是一家领先的数字医疗保健公司，专注于创建可检测、预测和预防疾病的可信解决方案，今天宣布，它已获得日本药品和医疗器械管理局（PMDA）对Zio®14天长期连续心电图监测系统的监管批准。

With regulatory approval in hand, iRhythm intends to work towards a reimbursement decision for the Zio ECG monitoring system with the Japanese Ministry of Health, Labour, and Welfare (MHLW)..

在获得监管部门的批准后，iRhythm打算与日本厚生劳动省（MHLW）就Zio ECG监测系统的报销做出决定。。

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 AI algorithm) that generates a comprehensive end-of-wear report reviewed and curated by certified cardiographic technicians.

Zio长期连续监测（LTCM）服务包括一个仅限处方的贴片心电图监测设备（Zio监护仪），佩戴时间长达14天，以及ZEUS（Zio心电图利用软件）系统（iRhythm的高级AI算法），该系统可生成一份由经过认证的心脏病学技术人员审查和策划的全面磨损结束报告。

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 enable doctors in making 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.

与传统的动态心电图监测相比，Zio系统代表了心律失常诊断的重大进步4，旨在提供高临床准确性，帮助医生首次做出正确的诊断。iRhythm的深度学习方法可以对广泛的不同心律失常进行分类，具有与心脏病专家相似的高诊断性能，并且在临床环境中，该服务可以减少误诊的计算机化心电图解释的数量并提高临床效率。

“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,” said Quentin Blackford, iRhythm President and Chief Executive Officer.

iRhythm总裁兼首席执行官昆汀·布莱克福德（QuentinBlackford）表示：“在日本心律协会合作伙伴的大力支持下，我们很高兴获得日本PMDA的批准，这证明了iRhythm致力于创新以及最高的质量和性能标准。”。

“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 during their market access and reimbursement review of the Zio service.”.

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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 monitoring4,5 and the significant need that patients in Japan face to improve detection of potential cardiac arrhythmias..

Zio系统之前由MHLW指定用于高医疗需求，这在日本是一个罕见的区别，被授予被认为对重大疾病具有高医疗效用的创新设备。与传统动态心电图监测相比，Zio服务提供的临床改进4,5以及日本患者面临的改善潜在心律失常检测的重大需求，根据JHRS的建议，Zio系统被指定为该名称。。

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 population2,3. However, Japanese patients are forced to use Holter monitoring, the traditional standard of care, as patch-based technology, like the Zio service, has not been adopted..

日本是世界第二大动态心脏监测市场，每年估计有160万次检测处方1，这一数字预计将继续增加，因为老龄化人群的中风和心血管疾病负担2,3。然而，日本患者被迫使用动态心电图监测，这是传统的护理标准，因为基于补丁的技术（如Zio服务）尚未被采用。。

Since the company’s inception, iRhythm has posted over 8 million patient reports and amassed a repository of approximately 1.8 billion hours of curated ECG data7. Zio monitor, Zio XT, and Zio AT (mobile cardiac telemetry) systems are currently available in the U.S., and Zio XT system is available in the UK.

自公司成立以来，iRhythm已经发布了800多万份患者报告，并积累了大约18亿小时的精选心电图数据7。Zio monitor、Zio XT和Zio AT（移动心脏遥测）系统目前在美国可用，Zio XT系统在英国可用。

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 them to prepare for market launch once reimbursement is approved by the MHLW..

此外，iRhythm最近宣布在奥地利、荷兰、西班牙和瑞士推出Zio监视器。iRhythm已与日本的分销合作伙伴签署了一份意向书，并正在积极与他们合作，为MHLW批准报销后的市场投放做好准备。。

About iRhythm Technologies, Inc.

关于iRhythm Technologies，Inc。

iRhythm is a leading digital health care company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information.

iRhythm是一家领先的数字医疗保健公司，它创建了可靠的解决方案，可以检测、预测和预防疾病。iRhythm将可穿戴生物传感器和基于云的数据分析与强大的专有算法相结合，将数百万次心跳中的数据提取成临床上可行的信息。

Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health for all. To learn more about iRhythm, including its portfolio of Zio products and services, please visit irhythmtech.com..

通过对患者护理的不懈关注，iRhythm的愿景是为所有人提供更好的数据，更好的见解和更好的健康。要了解更多有关iRhythm的信息，包括其Zio产品和服务组合，请访问irhythmtech.com。。

Investor Contact

投资者联系人

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斯蒂芬妮·扎德科维奇

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媒体联系人

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Annual Pharmaceutical Production Statistics, Ministry of Health, Labour, and Welfare (“MHLW”).

卫生、劳动和福利部（“MHLW”）年度药品生产统计数据。

Barrett P. et al. Comparison of 24-hour Holter monitoring vs. 14-day novel adhesive patch electrocardiographic monitoring. American Heart Journal of Medicine, 2014.

Barrett P.等人，《24小时动态心电图监测与14天新型贴片心电图监测的比较》。美国心脏医学杂志，2014年。

Hannun, AY. et al. Cardiologist-level arrhythmia detection and classification in ambulatory electrocardiograms using a deep neural network. Nature Medicine, 2019.

哈农，是的。。

Turakhia, M. et al. Diagnostic Utility of a Novel Leadless Arrhythmia Monitoring Device, American Journal of Cardiology, 2013.

Turakhia，M.等人，《新型无铅心律失常监测装置的诊断效用》，美国心脏病学杂志，2013年。

Data on file. iRhythm Technologies, 2024.

文件中的数据。iRhythm Technologies，2024年。

Source: irhythmtech.com

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