AMCG announced on the 19th that it will commence a clinical trial to evaluate the diagnostic accuracy of the myocardial magnetic field mapping system (MCG) scan for patients suspected of coronary artery disease.
Starting from the 19th, AMCG will initiate a multicenter clinical trial and plans to complete the clinical trial for early diagnosis of coronary artery disease by the end of 2024. The MCG scan equipment used in this trial received marketing authorization from the Ministry of Food and Drug Safety in June last year. In March, it passed the Institutional Review Board (IRB) reviews of Gachon University Gil Medical Center and The Catholic University of Korea Eunpyeong St. Mary's Hospital.
The clinical trial is conducted to evaluate the diagnostic accuracy of the MCG scan for early diagnosis of coronary artery disease. Approximately 600 patients will be enrolled, and the effectiveness and safety of the MCG scan will be verified through a one-to-one comparison with angiography results.
The MCG scan owned by AMCG is a system that diagnoses heart disease by detecting the subtle magnetic fields generated by the human body using SQUID (Superconducting Quantum Interference Device) sensors without the use of contrast agents or radiation. The company explains that the MCG scan can complement and replace current tests such as electrocardiograms used for diagnosing ischemic heart disease with a single MCG scan.
Seoyong Sung, CEO of AMCG, said, "Through this clinical trial, we will accumulate sufficient clinical data for heart disease diagnosis," adding, "Based on this, we will secure the diagnostic excellence of the MCG scan and do our best to establish it as a world-class heart disease diagnostic device."
Professor Kyunghoon Lee of the Department of Cardiology at Gachon University Gil Medical Center, participating in this clinical trial, stated, "We expect that the MCG scan will provide accurate diagnostic interpretation results in a short time without side effects to patients," and added, "We will lead a successful clinical trial to verify the diagnostic accuracy of the MCG scan."
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