AI-powered cardiac MRI solution enters Asian market with regulatory approval
Phantomics, a South Korean medical AI company, announced that its cardiac MRI analysis solution Myomics has received Class II medical device certification from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
Myomics enables non-invasive, contrast-free cardiac MRI scans to be completed in under 10 minutes, with AI-powered analysis delivered in less than 5 minutes. The solution supports early detection of heart conditions such as myocarditis, myocardial infarction, and heart failure, offering diagnostic accuracy comparable to tissue biopsy.
This PMDA certification follows Phantomics’ earlier FDA 510(k) clearance in the U.S., and marks a major step toward expanding into the Japanese healthcare market. The company is also pursuing AI certification from the Japan Radiological Society (JRS) and expects health insurance reimbursement eligibility by 2026.
CEO Pan Ki Kim stated, “PMDA approval validates the safety and effectiveness of Myomics. We’re committed to delivering AI solutions that improve cardiac care across Asia.”
Read the article (Digital Chosun)
AI-powered cardiac MRI solution enters Asian market with regulatory approval
Phantomics, a South Korean medical AI company, announced that its cardiac MRI analysis solution Myomics has received Class II medical device certification from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
Myomics enables non-invasive, contrast-free cardiac MRI scans to be completed in under 10 minutes, with AI-powered analysis delivered in less than 5 minutes. The solution supports early detection of heart conditions such as myocarditis, myocardial infarction, and heart failure, offering diagnostic accuracy comparable to tissue biopsy.
This PMDA certification follows Phantomics’ earlier FDA 510(k) clearance in the U.S., and marks a major step toward expanding into the Japanese healthcare market. The company is also pursuing AI certification from the Japan Radiological Society (JRS) and expects health insurance reimbursement eligibility by 2026.
CEO Pan Ki Kim stated, “PMDA approval validates the safety and effectiveness of Myomics. We’re committed to delivering AI solutions that improve cardiac care across Asia.”
Read the article (Digital Chosun)