Mezoo received FDA clearance last year for its ECG monitoring platform “HiCardi Plus (H100)” and its cloud-based analytics software “LiveStudio.” Unlike conventional devices that require ECG data to be sent to cloud servers for analysis, these solutions can analyze ECG data in real time directly on the device. They are currently in use across medical settings in Korea, and the company has also secured overseas certifications in markets such as Japan and Saudi Arabia, preparing for global expansion.

Experts anticipate that Korean companies’ entry into the U.S. market will extend beyond simple device sales to encompass AI analytics and cloud platforms. Korean firms are pursuing differentiation through miniaturization, accuracy, and price competitiveness. However, high entry barriers remain, including FDA approvals and the acquisition of insurance reimbursement codes. In practice, some companies have already obtained regulatory clearance, yet full-scale commercialization is still taking time.

The market outlook remains positive. According to market research firm IMARC, the global ECG device market is expected to grow from USD 6.1 billion in 2024 to approximately USD 11.2 billion by 2033, reflecting a compound annual growth rate of 6.93 percent.