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AMCG’s Cardiac Diagnostic Device ‘MCG-S’ Designated as an Innovative Product by MSIT Writer 최고관리자 Date 2026.07.06 18
AMCG’s Cardiac Diagnostic Device ‘MCG-S’ Designated as an Innovative Product by MSIT ☞ Link to Article 'MCG-S' Commercializes KRISS Quantum Sensor Technology Measures Ultra-Faint Cardiac Magnetic Fields… Enables Non-Invasive Early Diagnosis of Heart Diseases Designated as an Innovative Product by MSIT, Following MFDS Approval and U.S. FDA Clearance Targeting Public Screening Market for Younger Demographics in Their 20s and 30s Planning IPO Next Year… Leading the Global Cardiac Diagnostics Market AMCG, a company specializing in quantum sensor-based early heart diagnosis platforms, announced that its next-generation magnetocardiography system, 'MCG-S (Model: AM1000),' has been designated as an Excellent R&D Innovative Product (Category 1) by the Ministry of Science and ICT. This is the first time in South Korea that a medical device utilizing quantum sensors has been designated as an Innovative Product. Category 1 Innovative Products target the outcomes of national research and development (R&D) projects conducted by central administrative agencies. The relevant ministry evaluates and deliberates on technological innovation, public utility, and commercial viability, followed by deliberation and resolution by the Procurement Policy Deliberation Committee of the Ministry of Economy and Finance. Afterward, the Public Procurement Service registers and manages the product as an eligible target for non-competitive, sole-source contracts in public procurement. Beyond mere technical certification, this means that the nation has officially recognized both its commercialization capability and business viability in the procurement market. Companies designated for Innovative Products can enter into sole-source contracts without competitive bidding with national and local governments and public institutions for three years. They also receive public procurement incentives, such as the Public Procurement Service's pilot purchase program and liability exemption systems for procurement officers. AMCG expects that this will accelerate the adoption of MCG-S in national/public medical institutions and tertiary general hospitals. ◇ Detecting Subtle Functional Abnormal Signals in the Myocardium for Diagnosis MCG-S is a next-generation magnetocardiography system commercialized by receiving technology transfer of Superconducting Quantum Interference Device (SQUID) quantum sensor technology from the Korea Research Institute of Standards and Science (KRISS). It non-invasively measures ultra-fine magnetic fields generated by the heart's electrophysiological activity from outside the body, and ana lyzes them with artificial intelligence (AI) algorithms to quantify myocardial ischemia, electrophysiological abnormalities, and functional risk signals. Existing radiation-based imaging tests, such as Computed Tomography (CT) and Coronary Angiography (CAG), has strengths in identifying structural stenosis of blood vessels. On the other hand, magnetocardiography specializes in detecting subtle functional abnormal signals in the myocardium. MCG-S captures functional abnormal signals at a stage before structural lesions become apparent, drawing attention as an early diagnostic platform that fills the "functional gap" between existing tests. Since it requires no radiation or contrast agents, it is also suitable for repeated and long-term follow-up examinations. Following item approval by the Ministry of Food and Drug Safety (MFDS) in 2022 and US FDA 510(k) clearance in 2024, MCG-S achieved the Innovative Product designation this year. This designation is also meaningful in that it laid the foundation for R&D outcomes to lead to actual clinical sites and public procurement markets. In particular, amid growing demand for early detection of heart disease, it is evaluated as a case demonstrating the potential for non-invasive, radiation-free diagnostic technology to expand into the public screening domain. In the future, as clinical validity and utility acc umulate in clinical settings, it is expected to establish itself as a complementary diagnostic option used alongside existing heart examinations. ◇ AMCG Eyes Public Screening Market for Young Adults AMCG is paying attention to the public screening market targeting young adults in their 20s and 30s. Since this age group has few opportunities for regular cardiac examinations, heart abnormalities are often confirmed for the first time during military enlistment physical examinations or group health checkups. AMCG explains that MCG-S has high utility as a screening test because it can capture cardiac functional abnormality signals early, even in the asymptomatic stage. In particular, national and public medical institutions, including Armed Forces hospitals, are subject to sole-source contracts and pilot purchases for Innovative Products, making adoption easy. AMCG plans to leverage this to prioritize distribution centered on national and public medical institutions and then expand to the overall public healthcare infrastructure. Based on its track record in public procurement and health screening centers, AMCG plans to pursue an Initial Public Offering (IPO) next year. At the same time, using the FDA 510(k) approval as leverage, it will begin entering the North American market in earnest and target the European market as well. The company is accu mulating clinical evidence overseas by conducting strategic alliances and academic collaborations with local medical device partners and hospitals abroad. Yong-Seong Seo, CEO of AMCG, said, "AMCG possesses all three core elements: quantum sensor technology, AI-based interpretation capabilities, and procurement competitiveness through Innovative Product designation. Through MCG-S, we will contribute to discovering and preventing heart disease at an earlier stage, and particularly lend strength to early screening of asymptomatic heart abnormalities at military enlistment physical examination sites, where young adults examine their hearts for the first time." He added, "We will successfully complete the IPO next year and establish the quantum sensor-based K-cardiac diagnostic platform as a global standard, becoming a leading company in the global cardiac diagnostics market, centered on North America and Europe." [SenTV]

AMCG’s Cardiac Diagnostic Device ‘MCG-S’ Designated as an Innovative Product by MSIT

Writer 최고관리자

Date 2026.07.06

AMCG’s Cardiac Diagnostic Device ‘MCG-S’ Designated as an Innovative Product by MSIT

☞ Link to Article

'MCG-S' Commercializes KRISS Quantum Sensor Technology

Measures Ultra-Faint Cardiac Magnetic Fields… Enables Non-Invasive Early Diagnosis of Heart Diseases

Designated as an Innovative Product by MSIT, Following MFDS Approval and U.S. FDA Clearance

Targeting Public Screening Market for Younger Demographics in Their 20s and 30s

Planning IPO Next Year… Leading the Global Cardiac Diagnostics Market

AMCG, a company specializing in quantum sensor-based early heart diagnosis platforms, announced that its next-generation magnetocardiography system, 'MCG-S (Model: AM1000),' has been designated as an Excellent R&D Innovative Product (Category 1) by the Ministry of Science and ICT. This is the first time in South Korea that a medical device utilizing quantum sensors has been designated as an Innovative Product.

Category 1 Innovative Products target the outcomes of national research and development (R&D) projects conducted by central administrative agencies. The relevant ministry evaluates and deliberates on technological innovation, public utility, and commercial viability, followed by deliberation and resolution by the Procurement Policy Deliberation Committee of the Ministry of Economy and Finance. Afterward, the Public Procurement Service registers and manages the product as an eligible target for non-competitive, sole-source contracts in public procurement. Beyond mere technical certification, this means that the nation has officially recognized both its commercialization capability and business viability in the procurement market.

Companies designated for Innovative Products can enter into sole-source contracts without competitive bidding with national and local governments and public institutions for three years. They also receive public procurement incentives, such as the Public Procurement Service's pilot purchase program and liability exemption systems for procurement officers. AMCG expects that this will accelerate the adoption of MCG-S in national/public medical institutions and tertiary general hospitals.

◇ Detecting Subtle Functional Abnormal Signals in the Myocardium for Diagnosis

MCG-S is a next-generation magnetocardiography system commercialized by receiving technology transfer of Superconducting Quantum Interference Device (SQUID) quantum sensor technology from the Korea Research Institute of Standards and Science (KRISS). It non-invasively measures ultra-fine magnetic fields generated by the heart's electrophysiological activity from outside the body, and ana lyzes them with artificial intelligence (AI) algorithms to quantify myocardial ischemia, electrophysiological abnormalities, and functional risk signals.

Existing radiation-based imaging tests, such as Computed Tomography (CT) and Coronary Angiography (CAG), has strengths in identifying structural stenosis of blood vessels. On the other hand, magnetocardiography specializes in detecting subtle functional abnormal signals in the myocardium. MCG-S captures functional abnormal signals at a stage before structural lesions become apparent, drawing attention as an early diagnostic platform that fills the "functional gap" between existing tests. Since it requires no radiation or contrast agents, it is also suitable for repeated and long-term follow-up examinations. Following item approval by the Ministry of Food and Drug Safety (MFDS) in 2022 and US FDA 510(k) clearance in 2024, MCG-S achieved the Innovative Product designation this year.

This designation is also meaningful in that it laid the foundation for R&D outcomes to lead to actual clinical sites and public procurement markets. In particular, amid growing demand for early detection of heart disease, it is evaluated as a case demonstrating the potential for non-invasive, radiation-free diagnostic technology to expand into the public screening domain. In the future, as clinical validity and utility acc umulate in clinical settings, it is expected to establish itself as a complementary diagnostic option used alongside existing heart examinations.

◇ AMCG Eyes Public Screening Market for Young Adults

AMCG is paying attention to the public screening market targeting young adults in their 20s and 30s. Since this age group has few opportunities for regular cardiac examinations, heart abnormalities are often confirmed for the first time during military enlistment physical examinations or group health checkups. AMCG explains that MCG-S has high utility as a screening test because it can capture cardiac functional abnormality signals early, even in the asymptomatic stage.

In particular, national and public medical institutions, including Armed Forces hospitals, are subject to sole-source contracts and pilot purchases for Innovative Products, making adoption easy. AMCG plans to leverage this to prioritize distribution centered on national and public medical institutions and then expand to the overall public healthcare infrastructure.

Based on its track record in public procurement and health screening centers, AMCG plans to pursue an Initial Public Offering (IPO) next year. At the same time, using the FDA 510(k) approval as leverage, it will begin entering the North American market in earnest and target the European market as well. The company is accu mulating clinical evidence overseas by conducting strategic alliances and academic collaborations with local medical device partners and hospitals abroad.

Yong-Seong Seo, CEO of AMCG, said, "AMCG possesses all three core elements: quantum sensor technology, AI-based interpretation capabilities, and procurement competitiveness through Innovative Product designation. Through MCG-S, we will contribute to discovering and preventing heart disease at an earlier stage, and particularly lend strength to early screening of asymptomatic heart abnormalities at military enlistment physical examination sites, where young adults examine their hearts for the first time."

He added, "We will successfully complete the IPO next year and establish the quantum sensor-based K-cardiac diagnostic platform as a global standard, becoming a leading company in the global cardiac diagnostics market, centered on North America and Europe."

[SenTV]

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