PR

MEZOO, connecting health through technology
Sharing MEZOO’s technology and vision.
External
2025.12.22
Mezoo Receives EX871 Reimbursement Approval for Mobile Remote Patient Monitoring System

 

Mezoo Co., Ltd. (CEO Jung-hwan Park) announced on the 22nd that “remote monitoring by mobile cardiac rate technology” using its mobile remote patient monitoring system HiCardi has obtained the EX871 reimbursement code from the Health Insurance Review and Assessment Service (HIRA), thereby being recognized as a reimbursable medical service.

 

EX871 is a reimbursement code approved by the national health insurance system for medical services that remotely monitor a patient’s heart rate in real time while the patient is moving. With this approval, wearable-based real-time electrocardiogram monitoring technology has expanded beyond bed-centered, limited surveillance to a hospital-wide monitoring system designed for patient mobility.

 

Since May 2020, HiCardi has been the first wearable device to receive reimbursement for “in-bed ECG monitoring (E6544)” and has been stably operated in real clinical settings for more than five years, accumulating large-scale real-world evidence (RWE). The acquisition of the EX871 code is a result grounded in this clinical evidence and is significant in that the technology’s safety and sustainability have been institutionally validated.

 

EX871 applies to examinations for patients at high risk of arrhythmia who require real-time monitoring or continuous observation of treatment effects. Unlike the existing E6544, which is limited to bedridden patients, EX871 requires uninterrupted real-time monitoring even when patients are moving during outpatient visits or hospitalization, making the technical requirements considerably more demanding. Until now, solutions at this level were available only from a small number of global medical device companies and required separate hospital-wide wireless infrastructure, which limited their practical use.

 

HiCardi has overcome these limitations and has led the transition from bed- and ward-based surveillance to hospital-wide monitoring. It is designed to enable stable measurement and real-time transmission of vital signals regardless of patient location or movement path, and has been implemented in real clinical environments across numerous medical institutions. Currently, HiCardi is in use at approximately 350 medical institutions nationwide and is operated in more than 25 of the country’s 47 tertiary hospitals.


 https://www.etnews.com/20251222000463


적용 법률 및 규정
의료기기

하이카디® 시스템은 인허가에 따라 신생아, 소아, 청소년, 18세 이상 환자의 ECG 데이터를 측정하여 부정맥을 진단하는 의료기기로서 의료전문가가 사용하도록 설계되었습니다. 한국 KFDA로부터 의료기기 2등급 인증을 받았습니다. 유럽의료기기 지침(2007/47/EC에 따라 개정된 MDD 93/42/EEC)에 따라 준수된 Class IIb (CE2265). 의료기기 제품으로 CE 승인되었습니다. 미국 FDA는 Class II 510K로 승인 완료 예정입니다.

경고

본 자료는 의료 전문가에게만 배포되며 관련 사진과 함께 제공되는 자료와 관련하여 그 어떤 법적인 책임을 갖지 않습니다. 사용 전 사용 지침서를 주의 깊게 읽으십시오.