Phantomics, a leading medical imaging AI company (Co-CEOs Byung Wook Choi and Pan Ki Kim), announced that it has received FDA 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the enhanced version of its AI-based cardiac MRI analysis solution, Myomics. With this approval, Phantomics plans to officially enter the U.S. cardiovascular disease diagnostics market.
According to the company, FDA clearance is a critical prerequisite for software-based medical devices to enter the U.S. market and is also a globally recognized indicator of safety and performance. A Phantomics representative stated, "This clearance validates Myomics' AI-powered analytical capabilities, quality, and safety, further solidifying its credibility."
Building on this achievement, Phantomics aims to accelerate its global market expansion, including in the United States. As part of its strategy, the company has established a U.S. subsidiary at the CIC Center in Boston, a key hub for life sciences and healthcare industries, securing a strategic foothold for market penetration.
Cardiovascular disease is the leading cause of death worldwide, making early and precise diagnosis essential. Phantomics explained, "While cardiac MRI allows for a detailed evaluation of heart structure and function without radiation exposure, it has traditionally required significant time and specialized expertise for imaging and analysis. Our proprietary AI technology addresses these challenges."
With cutting-edge AI algorithms, Myomics reduces cardiac MRI analysis time from 20–30 minutes to under 5 minutes while maintaining high diagnostic accuracy. This efficiency allows for rapid diagnosis of heart failure, myocardial infarction, myocarditis, amyloidosis, and other cardiac conditions.
Currently, Myomics is deployed in over 20 major university hospitals in South Korea, as well as in hospitals across Japan, Taiwan, and Singapore. The solution has been recognized with the CES 2024 Innovation Award and the FIX Innovation Awards' Grand Prize.
Co-CEO Pan Ki Kim stated, "Receiving FDA clearance for the latest version of Myomics, in addition to previous approvals, is a significant milestone. We are committed to continuously advancing Myomics' technology and safety, driving growth in both the U.S. and global medical markets."
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Phantomics, a leading medical imaging AI company (Co-CEOs Byung Wook Choi and Pan Ki Kim), announced that it has received FDA 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the enhanced version of its AI-based cardiac MRI analysis solution, Myomics. With this approval, Phantomics plans to officially enter the U.S. cardiovascular disease diagnostics market.
According to the company, FDA clearance is a critical prerequisite for software-based medical devices to enter the U.S. market and is also a globally recognized indicator of safety and performance. A Phantomics representative stated, "This clearance validates Myomics' AI-powered analytical capabilities, quality, and safety, further solidifying its credibility."
Building on this achievement, Phantomics aims to accelerate its global market expansion, including in the United States. As part of its strategy, the company has established a U.S. subsidiary at the CIC Center in Boston, a key hub for life sciences and healthcare industries, securing a strategic foothold for market penetration.
Cardiovascular disease is the leading cause of death worldwide, making early and precise diagnosis essential. Phantomics explained, "While cardiac MRI allows for a detailed evaluation of heart structure and function without radiation exposure, it has traditionally required significant time and specialized expertise for imaging and analysis. Our proprietary AI technology addresses these challenges."
With cutting-edge AI algorithms, Myomics reduces cardiac MRI analysis time from 20–30 minutes to under 5 minutes while maintaining high diagnostic accuracy. This efficiency allows for rapid diagnosis of heart failure, myocardial infarction, myocarditis, amyloidosis, and other cardiac conditions.
Currently, Myomics is deployed in over 20 major university hospitals in South Korea, as well as in hospitals across Japan, Taiwan, and Singapore. The solution has been recognized with the CES 2024 Innovation Award and the FIX Innovation Awards' Grand Prize.
Co-CEO Pan Ki Kim stated, "Receiving FDA clearance for the latest version of Myomics, in addition to previous approvals, is a significant milestone. We are committed to continuously advancing Myomics' technology and safety, driving growth in both the U.S. and global medical markets."
Read Article