IRhythm Technologies Secures CE Mark for Zio® Monitor and ZEUS System Under EU MDR, Marking a Milestone in Medical Device Regulation

iRhythm Technologies, a key player in digital healthcare, has revealed that its latest Zio monitor ECG System, designed for prolonged ambulatory cardiac monitoring, has obtained the CE mark certification under the European Union's Medical Device Regulation 2017/745 ("EU MDR"). This certification, granted by the BSI Group, confirms adherence to EU MDR standards for performance, quality, safety, and efficacy, backed by substantial clinical evidence showcasing Zio's effectiveness in identifying potential cardiac arrhythmias.

The Zio monitor ECG System, an evolution of its predecessor Zio XT, offers improved long-term continuous cardiac monitoring services, ensuring a seamless end-to-end experience with an impressive 99% patient compliance with prescribed wear times. The newly introduced Zio monitor features a more discreet design, being thinner, lighter, and smaller compared to Zio XT.

With the EU MDR CE mark for both the Zio monitor and ZEUS systems, iRhythm is set to expand its market footprint across prioritized European countries, addressing the pressing clinical need for enhanced arrhythmia detection amidst the increasing prevalence of arrhythmias and strokes. The company aims to target regions where approximately 1.8 million ambulatory cardiac monitoring tests are conducted annually.


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