China's First Approved Magnetocardiography Device Set to Transform Cardiac Screening

VCBeat (WeChat ID: vcbeat) has learned that Mandi Medical Instruments (Shanghai) Co., Ltd.’s magnetocardiography (MCG) device has recently received a medical device registration certificate from the Shanghai branch of the China Food and Drug Administration (CFDA). This marks the first MCG device to gain regulatory approval in China.

Biomagnetic and bioelectric fields typically share a common physiological origin; the presence of a bioelectric field implies the existence of a biomagnetic field, and vice versa. Magnetocardiography (MCG) devices utilize built-in Superconducting Quantum Interference Devices (SQUIDs) to detect and visualize the extremely weak magnetic fields (in the picotesla [pT] range, weaker than the Earth’s magnetic field) generated by cardiac electrophysiological activity. Magnetocardiographic signals contain more comprehensive physiological information than electrocardiographic (ECG) signals, providing a better reflection of the heart’s physiological status. Abnormalities in cardiac depolarization or repolarization, such as those caused by coronary artery stenosis and ischemia, are manifested as anomalies in magnetocardiographic signals.

In China, approximately 11 million patients suffer from myocardial ischemia caused by coronary heart disease (CHD), accounting for 45% of patients with non-hypertensive cardiovascular diseases and 9% of all causes of death. Currently, the mainstream diagnostic methods for CHD include electrocardiography (ECG), coronary computed tomography angiography (CCTA), myocardial perfusion emission computed tomography (ECT), and coronary angiography.

Coronary angiography visualizes coronary artery lesions by injecting contrast agents after delivering a catheter to the coronary ostia via minimally invasive percutaneous access through the radial or femoral arteries. Although coronary angiography is the gold standard for diagnosing myocardial ischemia, it is an invasive diagnostic procedure.

Coronary CT angiography (CTA) involves the intravenous bolus injection of a contrast agent, followed by CT imaging of the coronary arteries. As it yields static images, certain filling defects not visible in specific planes may be missed, indicating a risk of misdiagnosis.

Myocardial perfusion ECT is a functional imaging technique that involves the injection of radioactive tracers. By leveraging the principle that these tracers participate in specific physiological or biochemical processes within the body, it visually displays the spatial distribution of myocardial perfusion function. A common drawback of the aforementioned three methods is their potential for radioactive harm to the human body. Electrocardiogram (ECG) examination is inexpensive, rapid, and free from radiation exposure; however, its major limitation lies in its low diagnostic accuracy.

Magnetocardiography (MCG) is characterized by its non-contact, non-invasive, and radiation-free nature, as well as its strong capability for early detection. Since its inception in the 1960s, it has garnered significant investment and attention from countries such as Germany, Japan, the United Kingdom, and the United States. After decades of development and clinical research, MCG is recognized as a medical technology with substantial potential for clinical application, particularly demonstrating prominent promise in the early diagnosis of ischemic heart diseases.

As early as 2003, CardioMag Imaging’s magnetocardiography (MCG) device received FDA 510(k) clearance for market launch in the United States. In recent years, with breakthroughs in MCG signal detection technology, MCG devices have become a focal point of international attention. MCG products from Germany’s BMP (2013), the UK’s Creavo (2017), and the US-based Genetesis (2019) have subsequently obtained FDA 510(k) clearance for commercialization.

In terms of diagnostic and treatment costs, a single coronary angiography procedure is priced at RMB 6,000–7,000. Currently, in Hong Kong, a magnetocardiography (MCG) test costs several thousand Hong Kong dollars. After achieving independent innovation and localizing production of this technology, Mandi Medical is expected to reduce the examination price to just a few hundred RMB.

Mand Medical Instruments (Shanghai) Co., Ltd. was jointly established by returning scientists and the Shanghai Institute of Microsystem and Information Technology (SIMIT) of the Chinese Academy of Sciences (CAS). Since 2006, the company’s technical team has worked in close collaboration with the research team led by Professor Xie Xiaoming, Director of SIMIT, to initiate the research and development of domestically produced magnetocardiography (MCG) equipment. With strong support from national, CAS, and Shanghai municipal projects, and after more than a decade of arduous technological breakthroughs, the company has successfully overcome foreign technical barriers and mastered proprietary MCG detection technology with independent intellectual property rights. The performance of the equipment has reached an internationally advanced level, and it recently obtained the medical device registration certificate issued by the Shanghai Food and Drug Administration (CFDA).