iRhythm Technologies announced 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 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.
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