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A Complete Guide to an ECG Machine’s Certifications, Standards & Compliances

Wellnest

Introduction Electrocardiogram (ECG) machines are vital in diagnosing and monitoring various cardiac conditions. ECG machine certification is crucial in achieving these goals and building trust among healthcare providers and patients. The Central Drugs Standard Control Organization (CDSCO) oversees ECG machine certification in India.

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

DAIC

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 milla1cf Wed, 01/03/2024 - 12:09 January 3, 2024 — iRhythm Technologies, Inc. , Data on file. Hannun, AY.

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When the repolarization wave strikes

HeartRhythm

A 25-year-old male, practicing endurance sports, but without any personal or familial history of cardiac disease, presented for a medical examination in view of his certification as a member of the Armed Forces.

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Italy’s Pioneering Push for Telemedicine. Supported by AI

Cardiomatics

This is radically simplifying the patient pathway for Electrocardiogram (ECG) tests. This requires obtaining local certification for the telemedicine system used, which must share data with public electronic health records that are being set-up for each region. The exact rules and systems for this vary per region.