iRhythm Technologies Receives European Union’s CE Marking Under Medical Device Regulation (EU MDR) for its Zio® monitor and ZEUS System

Rhea-AI Summary

iRhythm Technologies, Inc. (NASDAQ:IRTC) announced that its Zio monitor ECG System has received CE mark certification under the EU MDR, reinforcing its position as a leading innovation in ambulatory cardiac monitoring. The Zio monitor is thinner, lighter, and smaller compared to its predecessor, Zio XT, and incorporates the ZEUS (Zio ECG Utilization Software) System, iRhythm’s advanced deep-learned AI algorithm. The company plans to expand its market presence in Europe to address the significant unmet clinical need for improved arrhythmia detection.

Positive

• Zio monitor ECG System received CE mark certification under the EU MDR, showcasing compliance to stringent regulatory standards for healthcare technologies.
• The Zio monitor demonstrates improved wear times and analyzable ECG compared to traditional Holter monitoring, with 99% patient compliance with prescribed wear times.
• iRhythm plans to expand its market presence in Europe to address the significant unmet clinical need for improved arrhythmia detection.

Negative

• None.

Medical Device Regulatory Expert

The recent CE mark certification of iRhythm Technologies' Zio monitor ECG System under the European Union's Medical Device Regulation 2017/745 (EU MDR) represents a significant regulatory milestone. This certification is crucial because the EU MDR sets high benchmarks for medical device safety and performance. The certification process involves a comprehensive review of the device's clinical evidence, quality, safety and efficacy. The Zio monitor's compliance with these standards suggests that the device meets stringent European requirements, which could lead to increased adoption in the European market.

For stakeholders, this could mean a broader market reach and potential revenue growth for iRhythm Technologies in the European sector. The CE mark could also serve as a catalyst for market expansion strategies in prioritized European countries, tapping into the substantial market of approximately 1.8 million ambulatory cardiac monitoring tests performed annually. However, the company must navigate diverse healthcare systems, reimbursement challenges and competition in the European market. The long-term success will depend on the device's clinical adoption and the cost-effectiveness compared to traditional Holter monitoring solutions.

Cardiologist

The Zio monitor ECG System's enhanced capabilities for long-term continuous cardiac monitoring could be a game-changer in arrhythmia detection and management. The device's improved wearability, with a thinner, lighter and smaller design, may lead to higher patient compliance and longer monitoring periods, which is crucial for detecting intermittent arrhythmias. The reported 99% patient compliance rate is exceptional and could translate into more accurate and comprehensive data for diagnosing potential cardiac arrhythmias.

From a clinical perspective, the integration of the ZEUS (Zio ECG Utilization Software) System, which incorporates advanced deep-learned AI algorithms, can potentially improve the accuracy of ECG data analysis. This could reduce the workload for clinicians by minimizing false positives and improving the detection of clinically significant events. The improved clinical accuracy over traditional Holter monitors could lead to earlier and more precise interventions, which is critical given the rising prevalence of arrhythmias and associated stroke risk in Europe.

Healthcare Market Analyst

The strategic implications of iRhythm's CE mark certification for its Zio monitor ECG System extend beyond regulatory compliance. This achievement positions iRhythm to capitalize on the growing demand for digital health solutions in Europe. The advanced features and patient-centric design of the Zio monitor may provide iRhythm with a competitive edge in the ambulatory cardiac monitoring market, which is increasingly embracing wearable and AI-enabled technologies.

Given the rising prevalence of cardiac arrhythmias in Europe, the Zio monitor could address a significant unmet clinical need. However, market penetration will depend on factors such as reimbursement policies, healthcare provider adoption and patient preference. The ability of iRhythm to demonstrate the cost-effectiveness and clinical benefits of the Zio monitor compared to conventional monitoring methods will be critical in convincing both payers and providers to adopt this technology. The potential long-term benefits include better patient outcomes and reduced healthcare costs associated with untreated or poorly managed arrhythmias.

CE mark reinforces the Zio monitor system as a leading innovation in ambulatory cardiac monitoring and highlights the company’s commitment to providing the highest quality product and services globally

SAN FRANCISCO, Jan. 03, 2024 (GLOBE NEWSWIRE) -- 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 monitoring^6,7, 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 Contact
Stephanie Zhadkevich
(919) 452-5430
investors@irhythmtech.com

Media Contact
Saige Smith
(262) 289-7065
irhythm@highwirepr.com

1. Data on file. iRhythm Technologies, 2022.
2. Data on file. iRhythm Technologies, 2023.
3. Compared to previous generation.
4. Volume reflected in the device housing.
5. Hannun, AY. et al. Cardiologist-level arrhythmia detection and classification in ambulatory electrocardiograms using a deep neural network. Nature Medicine, 2019.
6. Barrett P. et al. Comparison of 24-hour Holter monitoring vs. 14-day novel adhesive patch electrocardiographic monitoring. American Heart Journal of Medicine, 2014.
7. Turakhia, M. et al. Diagnostic Utility of a Novel Leadless Arrhythmia Monitoring Device, American Journal of Cardiology, 2013.
8. 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. 

FAQ

What certification did iRhythm's Zio monitor ECG System receive?

iRhythm's Zio monitor ECG System received CE mark certification under the EU MDR.

What are the key features of the Zio monitor ECG System?

The Zio monitor is thinner, lighter, and smaller compared to its predecessor, Zio XT, and incorporates the ZEUS (Zio ECG Utilization Software) System, iRhythm’s advanced deep-learned AI algorithm.

What are iRhythm's expansion plans for the Zio monitor in Europe?

iRhythm plans to expand its market presence in Europe to address the significant unmet clinical need for improved arrhythmia detection.