Phantomics received medical device manufacturing certification from th…

Writer 관리자

Date 23-11-30 10:18

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Recently, Phantomics has received medical device manufacturing certification from the Ministry of Food and Drug Safety (MFDS) for Angiomics, an in-hospital coronary artery stenosis prediction platform.

The Platforms that utilize CT image information to predict the degree of coronary artery stenosis are medical devices and require certification of compliance with the Korean Good Manufacturing Practice (KGMP).

Phantomics has completed its KGMP compliance certification and has recently been certified and approved to manufacture and market Angiomics as our next product.

Based on this certification, we plan to conduct retrospective clinical trials through product advancement, and then complete the acquisition of a medical device manufacturing license to focus on entering the domestic medical device market!