iRhythm secures the CE mark certification for its Zio monitor ECG system under the European Union’s Medical Device Regulation (EU MDR), which also incorporates the CE mark for the Zio ECG Utilization Software (ZEUS) system, an advanced AI algorithm
iRhythm designed Zio monitor based on Zio XT. (Credit: iRhythm)
US-based medical equipment manufacturer iRhythm Technologies has received the CE mark for its next-generation long-term ambulatory cardiac monitor, Zio monitor ECG system.
The Zio monitor ECG system received the CE mark certification under the European Union’s Medical Device Regulation (EU MDR) from its Notified Body, the BSI Group.
The regulatory certification also incorporates the CE mark for the Zio ECG Utilization Software (ZEUS) system.
ZEUS is an advanced deep-learned AI algorithm, designed to support the capture and analysis of ECG data recorded by the Zio monitor.
The certification implies that the system meets the EU MDR standards of performance, quality, safety, and efficacy, along with evidence supporting its potential to detect cardiac arrhythmias.
iRhythm president and CEO Quentin Blackford said: “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.
“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 algorithm as key differentiators.”
iRhythm developed the Zio monitor based on the high performance of its Zio XT, which detects cardiac arrhythmia in people with palpitations, fainting and suspected cardiac arrhythmia.
Zio XT, together with the company’s enhanced long-term continuous cardiac monitoring, better serves patients with arrhythmias and shows 99% patient compliance with specified wear times.
The new Zio monitor is designed to be thinner, lighter, and smaller compared to the Zio XT and provide a more inconspicuous wear experience.
Also, the Zio monitor showed better wear times and analysable ECG, according to the early clinical and patient experience in the US, said the US medical device maker.
Furthermore, iRhythm said that there is a significant unmet clinical need for improved arrhythmia detection in Europe, with the increase in the prevalence of arrhythmias and stroke.
The CE mark for the Zio monitor and ZEUS systems will help the company expand operations across European countries, where ambulatory cardiac monitoring tests are performed annually.