Phantomics received medical device marketing authorization from the TFDA
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Date 24-05-31 15:49
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Phantomics has received medical device marketing authorization from the Taiwan Food and Drug Administration(TFDA).
Myomics, which recently obtained license and approval from Taiwan, is an AI-driven medical imaging solution developed by Phantomics in 2020. It extracts dozens of image biomarkers non-invasively using cardiac MRI, enabling various diagnosis of myocardial conditions.
Already in use in leading domestic hospitals and in Japan, China, Taiwan, and Singapore, Myomics has received approvals from regulatory bodies including the FDA in Korea, the USA, Thailand and Taiwan, attesting to its performance and safety.
With this FDA clearance, Phantomics expects to strengthen its overseas business step by step in the APAC market.
Article: https://www.docdocdoc.co.kr/news/articleView.html?idxno=3017655