Phantomics announced that it has received regulatory approval from Malaysia's regulatory authority, the Medical Device Authority Malaysia (MDA Malaysia), for its non-invasive cardiac disease diagnosis solution 'Myomics.' With this approval, Phantomics plans to begin full-scale sales of Myomics in Malaysia.
According to the company, Myomics utilizes AI to automatically analyze and quantify cardiac MRI images, providing safe and accurate diagnoses for heart diseases such as heart failure, myocarditis, and amyloidosis. Earlier this year, Myomics was awarded the CES 2024 Innovation Award, becoming the first medical imaging AI company in Korea to receive this recognition for its technology and innovation.
Notably, Myomics has demonstrated its value by enabling rapid treatment of patients in clinical settings. It is already in use at over 20 major hospitals in Korea, as well as in hospitals across Japan, China, Taiwan, Singapore, and other countries. The solution has also received recognition for its performance and safety, having obtained approvals from Korea’s Ministry of Food and Drug Safety (MFDS), as well as from Thailand, Taiwan, and the United States.
In February, Phantomics formed a partnership agreement with Getz Healthcare, the largest medical device and equipment sales company in the Asia-Pacific region, at their Malaysian branch. This collaboration led to the successful acquisition of regulatory approval in Malaysia.
Pan Ki Kim, CEO of Phantomics, said, "We are thrilled to contribute to the development of Malaysia’s healthcare environment with Myomics, which provides patients with quick diagnoses and timely treatment opportunities while enhancing the convenience for healthcare professionals. We expect that this FDA approval in Malaysia will enable us to expand Myomics sales throughout the Asia region, further growing our international business."
Phantomics plans to continue collaborating with local partners, including Getz Healthcare, to ensure that Myomics becomes widely used in Malaysia, the largest medical device market in ASEAN. The company also aims to expand its overseas business by entering various countries beyond Asia.
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Phantomics announced that it has received regulatory approval from Malaysia's regulatory authority, the Medical Device Authority Malaysia (MDA Malaysia), for its non-invasive cardiac disease diagnosis solution 'Myomics.' With this approval, Phantomics plans to begin full-scale sales of Myomics in Malaysia.
According to the company, Myomics utilizes AI to automatically analyze and quantify cardiac MRI images, providing safe and accurate diagnoses for heart diseases such as heart failure, myocarditis, and amyloidosis. Earlier this year, Myomics was awarded the CES 2024 Innovation Award, becoming the first medical imaging AI company in Korea to receive this recognition for its technology and innovation.
Notably, Myomics has demonstrated its value by enabling rapid treatment of patients in clinical settings. It is already in use at over 20 major hospitals in Korea, as well as in hospitals across Japan, China, Taiwan, Singapore, and other countries. The solution has also received recognition for its performance and safety, having obtained approvals from Korea’s Ministry of Food and Drug Safety (MFDS), as well as from Thailand, Taiwan, and the United States.
In February, Phantomics formed a partnership agreement with Getz Healthcare, the largest medical device and equipment sales company in the Asia-Pacific region, at their Malaysian branch. This collaboration led to the successful acquisition of regulatory approval in Malaysia.
Pan Ki Kim, CEO of Phantomics, said, "We are thrilled to contribute to the development of Malaysia’s healthcare environment with Myomics, which provides patients with quick diagnoses and timely treatment opportunities while enhancing the convenience for healthcare professionals. We expect that this FDA approval in Malaysia will enable us to expand Myomics sales throughout the Asia region, further growing our international business."
Phantomics plans to continue collaborating with local partners, including Getz Healthcare, to ensure that Myomics becomes widely used in Malaysia, the largest medical device market in ASEAN. The company also aims to expand its overseas business by entering various countries beyond Asia.
Read Article