Dong-A ST announced that its Hicardi+ H100 ECG monitoring platform, developed by digital healthcare startup Meju, has received 510(k) clearance from the US FDA. The platform, which includes the cloud-based software LiveStudio for biosignal analysis, provides continuous ECG and heart rate monitoring through a patch-type device.
Already in use in South Korea for cardiac disease screening, this FDA approval follows certifications from Japan and Saudi Arabia, marking a key milestone for Dong-A ST’s global ambitions. Notably, the Hicardi+ H100 is the first Korean smart patch to use on-device machine learning for real-time biosignal analysis.
With this clearance, Dong-A ST aims to accelerate its international market presence, especially in the US, the world’s largest digital healthcare market. CEO Jeong Jae-hoon emphasized the importance of this milestone for the company’s digital healthcare business, while Meju’s CEO Park Jeong-hwan sees the approval as a stepping stone for broader adoption of the Hicardi platform globally.
