[Financial News] AMCG Obtains US FDA Certification for Non-invasive Magnetocardiography MCG-S

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Diagnosing heart disease without contrast agents or radiation exposure

Medical device company AMCG announced on the 9th that its 'MCG-S', which enables early diagnosis without contrast agents or radiation exposure, has obtained U.S. Food and Drug Administration (FDA) 510(k) certification.

The Magnetocardiography (MCG) that received FDA certification this time is a magnetocardiography system manufactured by incorporating next-generation quantum sensor technology to detect very subtle magnetic signals from the electrical activity of myocardial cells.

This equipment is a state-of-the-art medical device that can accurately detect heart disease early, allowing measurements for diagnosis to be performed in a short time of about 5 minutes using a non-invasive method without any contrast agent use or radiation exposure. This is a diagnostic method that differentiates from existing diagnostic techniques.

In particular, this product has shown the possibility of accurate early diagnosis of ischemic heart disease in various clinical studies.

Currently, to obtain accurate results for heart disease tests, examinations are conducted step by step including electrocardiogram, echocardiography, cardiac nuclear medicine tests, and cardiac CT. However, there has been discomfort for patients due to side effects at the testing stage and the considerable time and period required for diagnosis.

AMCG said, "MCG system testing provides quick and accurate early test results and replaces various step-by-step invasive tests with a short testing time. We expect it to play a role as a game changer that can minimize the side effects of existing tests."

The MCG system received item approval from the Ministry of Food and Drug Safety in June 2022 and is currently conducting Phase 4 clinical trials to evaluate the diagnostic accuracy of MCG Scan for patients suspected of coronary artery disease at two institutions in Korea: Gachon University Gil Hospital and Eunpyeong St. Mary's Hospital. It is also expanding clinical institutions and additional indications.

Seo Yong-sung, President of AMCG, said, "Through this US FDA certification, we can now fully enter the US market, which is the world's largest medical device market."

President Seo said, "Since it can diagnose not only coronary artery disease but also various heart diseases early, I hope it will contribute to reducing the number of deaths from heart disease, which is the number one cause of death worldwide. We also plan to pursue strategic partnerships with global companies for future overseas expansion."

[Financial News Reporter Kang Jung-mo]