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Dong-A ST’s Hicardi+ H100 ECG Monitoring Platform Receives FDA Clearance

The approval paves the way for global expansion of the smart patch device utilizing real-time biosignal analysis
South Korea
d 170900.KO Mid and Small Cap 2000
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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.

 

 

 

 

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