Kunmai Medical Secures Global First Approval for Helium-Free MEG System, Leading Domestic Innovation in Advanced Functional Brain Imaging

From Import Monopoly to Domestic Leadership: The Global Industry Landscape of Magnetoencephalography (MEG) Is Being Reshaped.

Recently, QUANMAG’s self-developed “Magnetoencephalography (MEG) System” has received marketing approval from the National Medical Products Administration (NMPA) (Registration Certificate No.: Jing Xie Zhu Zhun 20242070274),It became the world’s first helium-free magnetoencephalography (MEG) device approved based on atomic magnetometer (also known as optically pumped magnetometer, i.e., OPM) technology.This device operates at room temperature without the need for liquid helium. Compared to traditional superconducting magnetoencephalography (MEG), optically pumped magnetometer (OPM) sensors can be placed closer to the scalp to acquire stronger magnetoencephalographic signals, while offering lower maintenance costs and enabling more flexible and diverse application scenarios.

Notably, prior to this, there were no liquid-helium-free magnetoencephalography (MEG) products approved for formal clinical use in the global market; all MEG systems that had previously obtained clinical registration were superconducting MEG devices based on Superconducting Quantum Interference Device (SQUID) technology.

This approval not only marks QUANMAG’s success in breaking the long-standing monopoly of imported brands on high-end brain functional imaging equipment, filling the clinical gap for domestically produced magnetoencephalography (MEG) systems, but also signifies that Chinese MEG technology has achieved a leapfrog advancement in cryogen-free quantum technology, transitioning from a follower to an industry leader. This breakthrough provides a cutting-edge new option in brain functional imaging for research on brain diseases and neuroscience.

QUANMAG's Self-Developed Liquid-Helium-Free Quantum Magnetoencephalography System

The brain is the most complex organ in the human body. Brain disorders have currently become the diseases imposing the heaviest burden on society, and the diagnosis and treatment of major brain diseases are also key tasks of the "China Brain Project." Currently, most clinical brain imaging equipment is oriented toward diagnosing structural lesions, making it difficult to achieve rapid and precise identification of brain functions.

Magnetoencephalography (MEG) provides dynamic information on changes in brain function by non-invasively measuring the magnetic fields generated by neural activity outside the scalp. It can precisely localize brain regions such as the visual, auditory, somatosensory, and motor cortices, and assess the strength and patterns of functional connectivity between different brain areas. Since magnetic signals are minimally affected by the skull and other brain tissues, MEG can capture nearly undistorted, real-time neural activity signals. It offers both high temporal resolution (millisecond level) and high spatial resolution (millimeter level), while being non-invasive and radiation-free, earning it recognition as a “next-generation neuroimaging technology.”

Currently, magnetoencephalography (MEG) has been widely applied in the preoperative localization and auxiliary assessment of epileptic foci and functional brain areas for neurosurgical procedures, and it has been incorporated into clinical practice guidelines and expert consensus statements both domestically and internationally. Furthermore, MEG plays a significant role in research related to the early diagnosis and formulation of treatment plans for psychiatric disorders, such as depression and schizophrenia, as well as neurodegenerative diseases, including Alzheimer’s disease and Parkinson’s disease.

“If common clinical imaging techniques such as CT and MRI are likened to cameras that capture static images of the brain, then magnetoencephalography (MEG) is more akin to a video camera capable of recording dynamic brain activity in real time. Although structural imaging modalities like CT and MRI can reveal lesions such as brain tumors, many neurological disorders do not exhibit characteristic findings on structural scans. In such cases, functional imaging techniques like MEG provide a unique perspective for gaining insights into abnormal brain function,” explained Sheng Jingwei, founder of QUANMAG.

Currently, commercialized magnetoencephalography (MEG) systems primarily rely on superconducting technology, known as superconducting MEG. These systems require Dewar vessels to contain liquid helium, ensuring a cryogenic, thermally insulated environment within the system. However, the thickness of the vacuum-insulated layer in these Dewar vessels is typically 2–3 cm, which limits the proximity of the sensors to the scalp and results in weaker signal detection. Furthermore, the rigid structure of the Dewar helmet constrains the spatial arrangement of the sensors, making it difficult to flexibly accommodate individual head contours and thus lacking universal applicability. In addition, superconducting MEG equipment requires the construction of large shielded rooms, imposing stringent site requirements and occupying significant floor space, thereby increasing installation costs.

More critically, superconducting magnetoencephalography (MEG) systems used in clinical practice in China rely heavily on imports, with each unit priced at RMB 30 million or even higher. The annual cost of liquid helium for maintenance alone approaches RMB 1 million. Moreover, the helium required for superconducting MEG is a scarce strategic resource on which China is highly dependent for imports. This dual dependency exposes China’s MEG sector to severe “chokehold” risks in both equipment procurement and liquid helium supply.

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These challenges have constrained the development and widespread adoption of magnetoencephalography (MEG) technology, a trend directly reflected in installation numbers—currently, there are only a few hundred MEG systems installed worldwide, predominantly in developed countries, with merely over 20 units in China. There is an urgent clinical need for a novel MEG technology to break through the current bottlenecks hindering its clinical promotion.

Leveraging early-stage R&D at Peking University and the translation of outcomes from the National Major Scientific Instrument Special Project funded by the National Natural Science Foundation of China, the QUANMAG medical team has been dedicated to the independent development and research of biomagnetic functional imaging equipment since 2015. After years of intensive efforts, the team successfully overcame a series of core technologies, including high-sensitivity magnetic sensing, open-type magnetic shielding, and high-precision magnetic inversion.

In 2017, the QUANMAG team published China’s first achievement in quantum-sensing magnetoencephalography in the journal Review of Scientific Instruments. In 2022, its magnetoencephalography (MEG) product was the first to receive certification as an innovative medical device in Beijing, and it successfully completed clinical trials in 2023. Today, QUANMAG has achieved full independence in developing both core MEG components and comprehensive system solutions, holding dozens of intellectual property rights.

QUANMAG’s independently developed magnetoencephalography (MEG) system, centered on its next-generation optically pumped magnetometer (OPM) sensors and integrated with an advanced magnetic shielding cylinder, operates without liquid helium or a dedicated magnetically shielded room. It enables real-time, non-invasive detection of magnetic fields generated by neural activity at room temperature, providing critical functional imaging evidence for the auxiliary diagnosis of brain disorders and localization of brain functional areas.

CCTV News Reports on QUANMAG’s Liquid-Helium-Free Quantum Magnetoencephalography

The detector is the “heart” of magnetoencephalography (MEG), and its performance directly impacts the clinical application and scientific research value of MEG. After a decade of dedicated development, QUANMAG has successfully advanced high-end brain functional imaging technology by exploring and continuously optimizing a weak magnetic field detection device based on a pure optical design pathway. This innovation has miniaturized the large-scale “atomic magnetometer,” which originally occupied a 4-square-meter platform, into a compact “optically pumped magnetometer (OPM)” with a cross-section no larger than a coin.Miniaturized OPM detectors can acquire magnetoencephalographic (MEG) signals in real time, noninvasively, and without radiation from outside the body. The signal strength is significantly higher than that of conventional superconducting MEG systems, offering advantages such as ultra-high sensitivity, scalability into arrays, high consistency, strong robustness, and multi-channel operation without crosstalk.

QUANMAG's Self-Developed Miniaturized Atomic Magnetometer,

Each individual cross-section measures only 2–3 cm², allowing for dense and flexible arrangement on the detection helmet.

Atomic magnetometers detect weak magnetic fields through light-atom interactions and operate without the need for liquid helium.QUANMAG’s magnetoencephalography (MEG) system, centered on atomic magnetometers, not only operates stably at room temperature but also features detectors that conform closely to the scalp, adapting to individual head contours to capture stronger neuromagnetic signals. Furthermore, compared with traditional MEG systems, which often incur annual maintenance costs reaching nearly one million yuan, this system significantly reduces both operational and maintenance expenses.

QUANMAG has also pioneered the use of a horizontal magnetic shielding device, replacing bulky traditional magnetic shielded rooms, thereby achieving both lightweight design and flexibility.The semi-open magnetic shielding cylinder adopts a multi-layer, non-uniformly spaced alloy architecture, which can effectively shield against external electromagnetic interference. Its shielding performance surpasses that of the magnetically shielded rooms used in traditional superconducting magnetoencephalography (MEG) systems. This design not only significantly reduces procurement, installation, and maintenance costs but also lowers the requirements for the installation site environment, greatly enhancing the convenience and feasibility of clinical deployment.

In practical applications, the device is also compatible with optical scanning-based spatial registration systems, enabling rapid and automatic high-precision co-registration of magnetoencephalography (MEG) data with anatomical brain images such as MRI, thereby achieving precise localization of brain activity regions.It significantly shortens the time required for the essential spatial co-registration process prior to source localization in magnetoencephalography (MEG), while addressing the potential lack of precision associated with traditional manual co-registration methods, thereby enhancing overall operational efficiency and accuracy.

Helium-free magnetoencephalography, with its unique technological advantages, demonstrates broad application prospects in the diagnosis and treatment of brain disorders. It is expected to provide robust foundational support for the diagnosis, therapy, and rehabilitation of brain diseases in the future—

• Preoperative Localization of Epilepsy and Brain Functional Areas:Prior to neurosurgery, magnetoencephalography (MEG) can precisely localize epileptic foci and critical functional brain areas, such as those responsible for language, vision, hearing, and somatosensation, thereby helping to preserve the integrity of these regions and prevent intraoperative injury.

• Neurodegenerative Diseases:Magnetoencephalography (MEG) can detect abnormal changes in brain activity at the early stages of neurodegenerative diseases, such as Alzheimer’s disease and Parkinson’s disease, providing a critical basis for their early diagnosis;

• Mental Disorders:It can be used for early screening and auxiliary diagnosis of mental disorders, such as depression, schizophrenia, and bipolar disorder;

• Pediatric Brain Development:Modular sensor arrays enable cryogen-free magnetoencephalography (MEG) to be applied in pediatric MEG measurements, facilitating assessments of brain development and auxiliary screening for neurological disorders in children.

• Assessment of Rehabilitation Efficacy:Magnetoencephalography (MEG) can be used to evaluate the efficacy of rehabilitation therapy. By comparing objective assessment metrics before and after treatment, it is possible to understand the impact of different rehabilitation interventions on the recovery of brain function, thereby providing guidance for the formulation and adjustment of rehabilitation treatment plans.

• Non-invasive Brain-Computer Interface:As an effective signal source, magnetoencephalographic (MEG) signals can also be utilized to develop non-invasive brain-computer interface (BCI) systems. These systems capture magnetic field signals generated by brain activity and, through signal processing and control algorithms, enable communication between the brain and external devices.

Furthermore, QUANMAG's liquid-helium-free quantum magnetoencephalography system has already beenWest China Hospital of Sichuan University, Sanbo Brain Hospital of Capital Medical University, Peking University, Harbin Institute of TechnologyIt has been installed and applied in numerous hospitals and universities, and has participated in the preparatory co-construction of multiple national major basic scientific facilities or projects, including the Multimodal Cross-Scale Biomedical Imaging Facility (Beijing Huairou).

Among these, the new cryogen-free magnetoencephalography (MEG) research installation project, a collaboration between QUANMAG and West China Hospital of Sichuan University, was awarded the title of “Research Demonstration Application for Domestically Produced High-End Equipment” by the Chinese Brain Imaging Alliance. This also marks the first accredited demonstration application of MEG based on OPM technology in China.

QUANMAG Wins the Honor of “Research Demonstration Application of High-End Domestically Produced Equipment”

Magnetoencephalography (MEG), as a brain functional imaging technique featuring both high temporal and high spatial resolution, is currently the ideal modality for non-invasively capturing real-time neural activity across the entire brain. It not only demonstrates significant potential in the precise detection of neurological disorders but also holds broad application prospects in the field of neuroscience research and applications.

The “14th Five-Year Plan” for the Development of the Medical Equipment Industry lists magnetoencephalography (MEG) measurement as a key area for development and identifies high-precision magnetic field sensors as core components to be tackled in the industrial foundation breakthrough initiative. Through nearly a decade of sustained efforts, QUANMAG has scaled technological heights, continuously overcome technical bottlenecks, and successfully developed both system solutions for MEG measurement and high-precision magnetic field sensors. At the inaugural Medical Equipment Innovation Competition held in March 2024, QUANMAG stood out among 435 cutting-edge innovation projects with this technological achievement.

Previously, commercially available magnetoencephalography (MEG) systems were primarily used for scientific research. According to data from the China Government Procurement Network and the China International Tendering Network, a total of 18 MEG devices were purchased by universities, research institutions, and medical facilities in China between 2014 and September 2023. These included 12 superconducting MEG systems and 6 optically pumped magnetometer (OPM)-based MEG systems, with three of the OPM-MEG systems supplied by QUANMAG.As of now, QUANMAG has completed the research-oriented installation and application of five magnetoencephalography (MEG) systems, holding a commanding lead in market share among domestic commercial counterparts.

With the approval of QUANMAG’s magnetoencephalography (MEG) system for market launch serving as a watershed moment, cryogen-free MEG has officially transitioned from the laboratory to clinical practice, ushering in a new era of large-scale application for high-end brain functional imaging technologies. This advancement not only provides numerous medical institutions with a key tool for visualizing brain activity but also holds promise for delivering new breakthroughs and hope in resolving long-standing clinical challenges.

Sheng Jingwei, founder of QUANMAG, pointed out that although the current applications of magnetoencephalography (MEG) are mainly concentrated in the field of auxiliary diagnosis, its potential extends far beyond this.How to integrate magnetoencephalography (MEG) with therapeutic interventions, such as using MEG to identify stimulable and treatable targets and constructing a closed-loop diagnostic and therapeutic system, remains an area requiring further exploration.Taking epilepsy as an example, the application of magnetoencephalography (MEG) should not be limited to the preoperative phase; rather, it should be integrated throughout the entire process of medication management and clinical diagnosis and treatment. This approach provides longitudinal assessments, enables a seamless transition from diagnosis to therapy, and establishes a more comprehensive closed-loop diagnostic and therapeutic framework.

On the other hand, thanks to its superior signal strength and source localization capabilities, magnetoencephalography (MEG) can provide richer information for studying brain function, demonstrating broad application potential in clinical diagnosis and treatment as well as scientific research. For instance, in the field of brain-computer interfaces (BCIs), helium-free MEG based on Optically Pumped Magnetometer (OPM) technology offers a new pathway for non-invasive, whole-brain-scale BCIs. This advancement facilitates breakthroughs in intelligent prosthetic control, brain-controlled devices, and neurological rehabilitation, while also opening up new directions for medical rehabilitation and the development of smart devices.

References:

1. "Next-Generation Atomic Magnetometer-Based Magnetoencephalography System Developed by Gao Jiahong’s Team Selected as a Major Scientific and Technological Achievement at the 2024 Zhongguancun Forum"

2. “The Past, Present, and Future of Magnetoencephalography (MEG) Systems”

3. "Decoding Brain Activity: Magnetoencephalography Leads New Frontiers in Neuroscience Research"

4. “Medical Observation | Decoding Brain Activity: Magnetoencephalography Leads New Frontiers in Brain Science Research”

5、《Magnetoencephalography with a Csbased high-sensitivity compact atomic magnetometer》

6、《Magnetoencephalography with optically pumped magnetometers (OPM-MEG): the next generation of functional neuroimaging》