Medical device company AMCG announced on the 9th that it has obtained FDA 510(k) certification for its magnetocardiography 'MCG-S' from the U.S. Food and Drug Administration (FDA).

The magnetocardiography (MCG) certified by the US FDA this time is a magnetocardiography system that uses tiny magnetic signals from the electrical activity of myocardial cells and next-generation quantum sensor technology.

This equipment is a state-of-the-art medical device that can accurately detect heart disease early. It has the characteristic of performing measurements for diagnosis in a short time of about 5 minutes using a non-invasive method without any contrast agent use or radiation exposure.

AMCG explained that magnetocardiography has shown the possibility of accurate early diagnosis of ischemic heart disease in various clinical studies. Current heart disease tests require step-by-step examinations including electrocardiogram, echocardiography, and cardiac nuclear medicine tests to obtain accurate results, but there are side effects at the testing stage and diagnosis takes a lot of time and period.

In contrast, MCG system testing can provide test results quickly and accurately early by replacing most of the step-by-step invasive tests with the equipment compared to existing systems, according to AMCG. AMCG expects the equipment to serve as a game changer that minimizes the side effects of existing equipment.

AMCG's magnetocardiography technology was developed by Dr. Lee Yong-ho's team at the Korea Research Institute of Standards and Science (KRISS), who researched Superconducting Quantum Interference Device (SQUID) technology for more than 20 years. In March 2021, KRISS transferred the system technology to AMCG for commercialization. The MCG system received item approval from the domestic Ministry of Food and Drug Safety in June 2022.

Currently, the MCG system is conducting Phase 4 clinical trials to evaluate the diagnostic accuracy of MCG Scan for patients suspected of coronary artery disease at two institutions: Gachon University Gil Hospital and Eunpyeong St. Mary's Hospital. AMCG is 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. I hope it will contribute to reducing the number of deaths from heart disease, which is the number one cause of death worldwide."

He added, "We will also pursue strategic partnerships with world-class global medical device companies for overseas expansion as well as domestic markets so that AMCG can become a leading company in K-medical."

[Money Today Reporter Park Soo-hyun]