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2026.09.16
HiCardi M350 Blood oxygen saturation measurement Approved by the Ministry of Food and Drug Safety (MFDS)

Chest-Worn Patch Measures SpO₂; Integrates ECG, Temperature, and Other Vital Signs; Blood Pressure Monitoring Approval Expected in Q4

Digital healthcare company Meju has demonstrated its ability to measure blood oxygen saturation (SpO₂) using a chest-worn wearable device. Moving beyond ECG-centered monitoring, the company is expanding into an integrated platform for continuous monitoring of multiple vital signs.
 

On the 14th, Meju announced that it had received MFDS approval for a modification to its next-generation wearable patient monitoring device, HiCardi M350, adding SpO₂ measurement functionality.
 

HiCardi M350 had previously received MFDS manufacturing approval for multichannel electrocardiogram (ECG), respiratory rate, and continuous body-temperature monitoring. With the latest approval, the addition of SpO₂ monitoring expands the device into a multiparameter patient monitor that enables real-time, integrated management of four key vital signs with a single patch.
 

SpO₂ is generally measured using optical sensors attached to the finger or earlobe. However, the need for separate wired cables can restrict patient movement and reduce wearing comfort. Obtaining reliable optical signals from the chest is particularly challenging, as blood-flow signals are weaker than in peripheral areas and more vulnerable to motion-related noise.
 

Meju applied proprietary signal-processing technology tailored to chest signals, along with reflective photoplethysmography (PPG), and demonstrated performance in a clinical trial for regulatory approval. The technology enables stable monitoring without a finger sensor or cable connection, making it well suited to mobile remote patient-monitoring settings within hospitals.

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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.

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