According to the China Medical Device Innovation and Priority Approval Database, one innovative medical device has entered the special review process in a public announcement released by local drug regulatory authorities across the country: the fetal magnetocardiography of Mandi Medical Instruments (Shanghai) Co., Ltd. (hereinafter referred to as Mandi Medical).

Fill the domestic gap
Mandi Medical was founded in 2009 and is an innovative enterprise specializing in the research and development, production, and sales of biomagnetic medical imaging equipment. It is committed to becoming a global leader in China's biomagnetic diagnostic solutions. Moreover, Mandy Medical is currently the first domestic enterprise to obtain the Shanghai CFDA medical device registration certificate for cardiac magnetic examination equipment. It has a series of core bio magnetic technologies, strong capital strength, and a first-class talent team.

The magnetocardiogram (MCG) is a functional examination device that uses highly sensitive magnetic detectors to detect, collect, and analyze human cardiac magnetic field signals. It has the characteristics of high signal fidelity and high sensitivity to local myocardial currents, and has natural advantages in technical principles. With its sensitivity, speed, non invasiveness, and non radiation characteristics, it has opened up new horizons for clinical doctors in myocardial ischemia functional examination. The main technological paths of current magnetocardiography include low-temperature superconductivity (SQUID) technology and atomic optical pumping (OPM) technology.

From the current international situation, there is a lack of methods for fetal cardiac assessment, especially arrhythmia assessment. Moreover, due to factors such as high technological and price barriers for fetal magnetocardiography equipment, compared to foreign countries, the development and clinical application of fetal magnetocardiography devices in China are still in their infancy. Therefore, the development of fetal magnetocardiography (fMCG) is of great significance for improving the current situation.

It is reported that the fetal magnetocardiogram, which entered the special review procedure this time, can record and analyze the fetal heart rate, heart rate variability, fetal motility and fetal heart rhythm through the cooperation of Mandi Medical, Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine, and Chinese Academy of Sciences Shanghai Microsystem and Institute of Information Technology. It has been included in the guidelines of the American Cardiovascular Association (AHA) for the evaluation of fetal arrhythmia, suspicious abnormal cardiac conduction, and sinus node/atrioventricular node abnormalities (IIa/B).

For fetuses over 17 weeks old, fetal magnetocardiography can accurately record the original fetal rhythm information and analyze fetal heart rhythm trends, filling the gap in this medical field. It is worth mentioning that currently only a very small number of countries in the world have the ability to develop this instrument, so the significance of Mandy Medical's fetal magnetocardiography for domestic research and development transformation is very significant.
In addition, Mandy Medical's Mandy Listening ® The high-sensitivity magnetocardiography instrument was launched at the 17th Eastern Cardiology Conference on May 28, 2023, and the company has begun to develop the next generation of zero liquid helium magnetocardiography equipment based on low-temperature superconducting technology, and has laid out the atomic light pump technology path to achieve full industry chain development, in order to adapt to different application scenarios such as precise high-end scientific research and convenient popularization.

Further rise of domestic power
According to the Medicine Intelligence Data Investment Pattern Database, Mandi Medical has completed 4 rounds of financing, with the latest round being in August 2023, when the company completed an A+round financing of 100 million yuan. The financing will mainly be used for the research and development iteration of cardiac magnetic technology, conducting large-scale MCG clinical research, and promoting the establishment of domestic cardiac magnetic clinical standards. Its financing purposes also include the clinical trial registration of the fetal cardiac magnetic imaging device that has entered the special review procedure.

The market size of magnetocardiography equipment laid out by Mandy Medical Institute is also constantly increasing. According to data, the Chinese magnetocardiography market is expected to maintain steady development. The market size of China's magnetocardiography industry is expected to reach approximately 907 million yuan in 2024, and is projected to reach 23.4 billion yuan by 2027.

At present, enterprises in China that have laid out in the field of magnetocardiography have gradually entered the harvest period. In addition to Mandi Medical, there are also domestic innovative equipment companies such as Xinci Technology, Wuci Technology, Nochi Life Technology, and Cardi Merck, all of which are focused on the field of magnetocardiography.

According to the "China Listed Device Screening System" in the "Pharmaceutical Intelligence Medical Equipment Data", in 2025, Beijing Weimi Medical Technology Co., Ltd.'s magnetocardiography instrument was approved for market. The product is a 64 channel liquid helium free magnetocardiography product, which adopts industry-leading 64 channel crosstalk free magnetic field detection array technology and non-magnetic three-axis position adjustment technology. It uses a high-sensitivity atomic magnetometer with independent intellectual property rights to achieve non-invasive, radiation free, and completely non-invasive detection of cardiac magnetic field signals, without the need for superconducting low-temperature equipment. It has the advantages of working at room temperature, low power consumption, and easy maintenance, and has broad application prospects in clinical medicine fields such as heart and cardiovascular research.

With the approval of more and more high-end medical devices such as magnetocardiography, it covers the fields of non-invasive diagnosis of coronary heart disease, localization of arrhythmia lesions, fetal arrhythmia detection, and even many products are the first in the country and even the world, symbolizing the further rise of domestic strength.

Source: https://news.yaozh.com/archive/45082.html