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2025.09.19
[AI Medical Technologies Sorting the Gems from the Stones] After Lunit, Can Second-Generation Companies Also Join the ₩1 Trillion Club… Who Is the Rising Dark Horse?

 

Mezoo recently passed a technology evaluation and plans to file for a preliminary KOSDAQ listing review later this month, with the goal of going public by January next year. The company is drawing attention for enabling broader biosignal remote monitoring on a single device compared to peers such as Seers Technology. Mezoo has obtained U.S. Food and Drug Administration (FDA) clearance for its patch-based remote monitoring system and is preparing for rapid market entry.

 

Jung-hwan Park, CEO of Mezoo, explained that from the outset the company developed its hardware platform specifically for remote monitoring purposes. He noted that the system does not only monitor electrocardiograms but can also measure a wide range of vital signs, including respiration, body temperature, blood pressure, and oxygen saturation, giving it a broad set of parameters. He further emphasized that even if a critical situation occurs during monitoring, the device can withstand electrical shocks delivered for cardiopulmonary resuscitation while remaining attached to the patient. He added that Mezoo is fully prepared for use beyond hospital settings once the regulatory and institutional environment for remote monitoring becomes fully established.



https://www.edaily.co.kr/News/Read?newsId=01088966642301760&mediaCodeNo=257&OutLnkChk=Y 

 

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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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