Zio Granted High Medical Needs Designation by the Japanese Ministry of Health, Labour, and Welfare
Designation reflects recommendation by the Japanese Heart Rhythm Society (JHRS)
Shonin pre-market application submitted by iRhythm in July 2023
SAN FRANCISCO, Aug. 03, 2023 (GLOBE NEWSWIRE) -- (NASDAQ:IRTC), a leading digital health care company focused on creating trusted solutions that detect, predict, and prevent disease, announced today that its application for manufacturing and marketing approval for Zio Monitor System in Japan has been designated for high medical needs by the Japanese Ministry of Health, Labour, and Welfare (“MHLW”). The high medical needs designation in Japan is granted to innovative devices recognized as having high medical utility for significant diseases.
The Zio Monitor System was indicated for this designation at the recommendation of the Japanese Heart Rhythm Society based on the clinical improvement that Zio services provides compared to traditional Holter monitoring1 and the significant need that patients in Japan face to improve detection of potential cardiac arrhythmias. With this classification in hand, iRhythm submitted its Shonin pre-market application to the Japanese Pharmaceutical and Medical Device Agency (the “PMDA”) on July 31, 2023.
“We are delighted that the Ministry of Health, Labour, and Welfare has granted high medical need designation to the Zio Monitor System as we seek to drive better health outcomes and more equitable access for patients around the globe,” said Quentin Blackford, iRhythm President and Chief Executive Officer. “Working in close collaboration with the Japanese Heart Rhythm Society, our teams did an exceptional job to effectively convey Zio services’ improved clinical accuracy compared to existing traditional Holter monitoring standard of care1,2, the significant body of clinical study evidence regarding the Zio services, and our deep-learned AI algorithm3 as key differentiators. We look forward to continuing our collaboration with the Japanese Heart Rhythm Society and the Japanese Pharmaceutical and Medical Device Agency during their review of our regulatory dossier.”
Japan is the second largest ambulatory cardiac monitoring market in the world with an estimated 1.5 million tests prescribed annually – a number that is expected to continue to increase based on stroke and cardiovascular disease burden in an aging population4,5. However, detection of potential arrhythmias amongst Japanese patients predominantly utilizes the traditional Holter monitoring as standard of care with very limited adoption of patch-based technologies.
About 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. 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 .
Investor Relations Contact:
Stephanie Zhadkevich
(919) 452-5430
iRhythm Media Contact:
Saige Smith
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- Barrett P. et al. Comparison of 24-hour Holter monitoring vs. 14-day novel adhesive patch electrocardiographic monitoring. American Heart Journal of Medicine, 2014.
- Turakhia, M. et al. Diagnostic Utility of a Novel Leadless Arrhythmia Monitoring Device, American Journal of Cardiology, 2013.
- Hannun, AY. et al. Cardiologist-level arrhythmia detection and classification in ambulatory electrocardiograms using a deep neural network. Nature Medicine, 2019.
- Matsuda S. Health Policy in Japan - Current Situation and Future Challenges. JMA Journal, 2019.
- Annual Pharmaceutical Production Statistics, Ministry of Health, Labour, and Welfare (“MHLW”).
