Zio Granted High Medical Needs Designation by the Japanese Ministry of Health, Labour, and Welfare
03 Agosto 2023 - 5:10PM
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 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 irhythmtech.com.
Investor Relations Contact:Stephanie
Zhadkevich(919) 452-5430investors@irhythmtech.com
iRhythm Media Contact:Saige Smith(262)
289-7065irhythm@highwirepr.com
- 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”).
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