Phantomics announced that it has received regulatory approval for its non-invasive myocardial disease diagnosis solution, Myomics, from the Medical Device Authority Malaysia (hereinafter referred to as MDA Malaysia). With this approval, Phantomics plans to officially launch the sale of Myomics in Malaysia.

According to the company, Myomics automatically analyzes and quantifies cardiac MRI images using artificial intelligence (AI), enabling the safe and accurate diagnosis of myocardial diseases such as heart failure, myocarditis, and amyloidosis. Earlier this year, the technology was recognized for its innovation and received the CES 2024 Innovation Award, marking a first for the Korean medical imaging AI industry.

Notably, Myomics has proven its value by supporting rapid patient treatment in medical settings. It is currently being used in over 20 top-tier general hospitals in Korea, as well as in hospitals around the world, including Japan, China, Taiwan, and Singapore. It has also been approved by the Korean Ministry of Food and Drug Safety and has received regulatory approvals in Thailand, Taiwan, and the United States due to its performance and safety.

In February, Phantomics signed a partnership agreement with Getz Healthcare, the largest medical device and equipment sales company in the Asia-Pacific region, specifically its Malaysian branch. This collaboration facilitated the acquisition of regulatory approval in Malaysia.

CEO Pan Ki Kim expressed, “We are pleased to contribute to the advancement of Malaysia's healthcare environment by providing cardiovascular disease patients with timely diagnoses and treatments while also enhancing convenience for healthcare professionals through Myomics. We expect that this Malaysian FDA approval will allow us to expand the sales of Myomics in the Asian region, further strengthening our international business.”

Phantomics aims to continue collaborating with local partners, including Getz Healthcare, to ensure that Myomics is prominently utilized in Malaysia, the largest medical device market in ASEAN, while also planning to expand its international business beyond Asia.

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