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[Korea Biomedical Review] Korea’s 1st long-term continuous ECG device gets FDA approval Admin 2022-10-19 11:51:56

[Korea Biomedical Review] Korea’s 1st long-term continuous ECG device gets FDA approval

OCT.18.2022

 

- AT-Patch (ATP-C130) is the first domestic long-term continuous wearable ECG device to be licensed in the U.S. (FDA Clearance, Medical Device Class Ⅱ)

- Although it is a single channel, it is possible to record clear ECG signals including P-Wave.

- The CEO said "We will accelerate its entry into the U.S. Market as it has successfully passed the largest regulatory gateway.

 

http://www.koreabiomed.com/news/articleView.html?idxno=14822

 

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