MultiChannel ECG, Arrhythmia Suspicion Signal Detection, and Continuous Temperature Monitoring Supported; Distribution Through Dong-A ST Stepwise Expansion Planned for SpO₂ and Blood Pressure-Related Functions Through Regulatory Approval Procedures
Digital healthcare company MEZOO announced that it has obtained medical device manufacturing approval from the Ministry of Food and Drug Safety for its next-generation wearable patient monitoring device, HiCardi M350, and plans to proceed with the product commercialization process in stages this year.
This manufacturing approval marks the first step in the phased commercialization of HiCardi M350. The initially approved functions include ECG, respiration, and continuous temperature monitoring. HiCardi M350 is a wearable patient monitoring device attached to the patient’s chest area, designed to continuously monitor multi-channel ECG signals and heart rate, while also providing arrhythmia suspicion signal detection and continuous temperature monitoring functions. The measured biosignals and device status information support healthcare professionals in monitoring patient conditions.
According to MEZOO, the HiCardi product lineup began with a single-channel ECG-based wearable monitoring device and later expanded to HiCardi+, which combined ECG and respiration monitoring, and HiCardi M300, which enhanced multi-channel ECG measurement capabilities. The newly approved HiCardi M350 represents the next stage in this evolution by integrating multi-channel ECG, respiration, and continuous temperature monitoring into a next-generation wearable patient monitoring device.
The company stated that this approval is significant because it marks the expansion of MEZOO’s wearable patient monitoring devices from conventional ECG-focused systems to hospital-grade multi-parameter wearable patient monitoring devices combining multi-channel ECG and multiple biosignal monitoring functions. HiCardi M350 is designed to operate for up to 48 hours on a single charge, supporting continuous biosignal monitoring in hospital patient care environments.
