iRhythm Technologies Receives European Union’s CE Marking Under Medical Device Regulation (EU MDR) for its Zio® monitor and ZEUS System
03 Gennaio 2024 - 2:00PM
iRhythm Technologies Receives European Union’s CE Marking Under
Medical Device Regulation (EU MDR) for its Zio® monitor and ZEUS
System
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 next
generation long-term ambulatory cardiac monitor – the Zio monitor
ECG System – has received CE mark certification under the European
Union’s Medical Device Regulation 2017/745 (“EU MDR”) from its
Notified Body, the BSI Group. The Zio monitor ECG System secured
its CE mark based on compliance to EU MDR standards of performance,
quality, safety, and efficacy, along with the body of clinical
evidence supporting Zio in detecting potential cardiac arrhythmias.
Zio monitor builds on the high performance of Zio XT that,
together with its enhanced long term continuous cardiac monitoring
service, provides an elevated end-to-end experience to patients
with potential arrhythmias and demonstrates 99% patient compliance
with prescribed wear times1. The new Zio monitor is thinner,
lighter, and smaller compared to Zio XT to provide a more
inconspicuous wear experience.2-4. Early clinical and patient
experience in the United States has shown that Zio monitor has even
better wear times and analyzable ECG2. Furthermore, the
certification incorporates CE mark for the ZEUS (Zio ECG
Utilization Software) System, iRhythm’s advanced deep-learned AI
algorithm which supports the capture and analysis of ECG data
recorded by Zio monitor.
“The EU MDR is arguably one of the most stringent regulatory
frameworks for product approvals globally that ensures medical
devices meet the rigorous standards for healthcare technologies,”
said Quentin Blackford, iRhythm President and Chief Executive
Officer. “Receiving this CE mark certification for our Zio monitor
and ZEUS system reflects our team’s commitment to delivering the
highest quality services as we seek to drive better health outcomes
and more equitable access for patients around the globe. Our teams
did an excellent job to effectively convey the significant body of
clinical study evidence underlying our Zio services and our
deep-learned AI algorithm5 as key differentiators. With improved
clinical accuracy compared to existing traditional Holter
monitoring6,7, we look forward to introducing our innovative
technology to many more patients in Europe.”
In Europe, there remains significant unmet clinical need for
improved arrhythmia detection in many countries as the prevalence
of arrhythmias and stroke continues to rise8. With the EU MDR CE
mark for the Zio monitor and ZEUS systems in hand, iRhythm plans to
continue its market expansion strategy in prioritized countries
across Europe where there are approximately 1.8 million ambulatory
cardiac monitoring tests performed annually.
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 ContactStephanie
Zhadkevich(919) 452-5430investors@irhythmtech.com
Media ContactSaige Smith(262)
289-7065irhythm@highwirepr.com
- Data on file. iRhythm Technologies, 2022.
- Data on file. iRhythm Technologies, 2023.
- Compared to previous generation.
- Volume reflected in the device housing.
- Hannun, AY. et al. Cardiologist-level arrhythmia detection and
classification in ambulatory electrocardiograms using a deep neural
network. Nature Medicine, 2019.
- 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.
- Mensah, AH. Et al. Global Burden of Cardiovascular Diseases and
Risks, 1990-2022. Journal of the American College of Cardiology,
2023.
*Referenced clinical studies and data are based on U.S. subject
population.
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