Deutsch
Español
Français
Italiano
Nederlands
Polski
Português
Русский
Türkçe
Svenska
Chinese
MagyariRhythm Zio wearable ECG with AI detection of heart problems gains EU medical device certification
The Zio wearable ECG from iRhythm Technologies has gained EU medical device certification for monitoring the heart. The software powered by machine learning across millions of ECGs as well as artificial learning can accurately detect cardiac arrhythmias, moments when the heart is not beating correctly, as accurately as a doctor.
Cardiac arrhythmias are common in the modern countries with many sufferers dying from heart failure, heart attacks, and strokes due to poor blood flow. Early detection allows doctors to prescribe medications and lifestyle changes that can treat this condition. Typically, this requires a patient to be hooked up to a Holter Monitor, a portable ECG with 12 wires attached to the body to record heart beat electrical signals. However, the bulk of the Holter coupled with its 1 to 2 day recording period makes it less effective at detecting infrequent signs of arrhythmias.
The Zio only requires one small patch monitor to be attached to the body. Patients don't mind wearing it for long periods because it is waterproof, lightweight, and small. The monitor can be worn while exercising, showering, and sleeping resulting in better, faster diagnosis versus other methods.
While the Zio requires a prescription by a physician in Europe or America, you can begin monitoring your heart for abnormalities today with the Garmin ECG app using one of their compatible smartwatches (like this one at Amazon).
Source(s)
iRhythm Technologies Receives European Union’s CE Marking Under Medical Device Regulation (EU MDR) for its Zio® monitor and ZEUS System
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
January 03, 2024 08:00 ET
Source: iRhythm
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 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 Contact
Stephanie Zhadkevich
(919) 452-5430
[email protected]
Media Contact
Saige Smith
(262) 289-7065
[email protected]
- 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.
