2024/09/26 

Dong-A ST announced on September 26 that the ECG monitoring platform “Hicardi+ H100,” developed by the digital healthcare startup Meju, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This approval also includes the cloud-based software “LiveStudio,” which medical professionals can use for biosignal analysis and report generation.

Hicardi+ H100 is a patch-type digital healthcare device that measures ECG, heart rate, and other metrics, providing long-term continuous ECG monitoring. It is widely used in Korea for cardiac disease screening in outpatient clinics, health check-up centers, and veterans hospitals.

The recent FDA approval follows certifications from Japan's PMDA and Saudi Arabia's SFDA, and it is expected to serve as a driving force for Dong-A ST's global market expansion. This certification is significant as it marks the first instance in Korea of a smart patch utilizing 'on-device machine learning' technology to analyze biosignals in real-time directly from the patch itself.

Jeong Jae-hoon, CEO of Dong-A ST, stated, "2024 was a period when the ‘Hicardi' solution, a core pipeline of Dong-A ST's new digital healthcare business, was establishing itself in the domestic market," adding, "We will accelerate our efforts to support overseas expansion with the FDA approval as a catalyst."

Park Jeong-hwan, CEO of Meju, commented, "This certification was achieved through continuous consultation and support from various organizations," and noted, "The FDA approval will serve as a stepping stone for the diverse pipelines of the Hicardi solution to enter the world's largest digital healthcare market."



Source : https://www.businesskorea.co.kr/news/articleView.html?idxno=225823