Breakthrough: Two Innovative Medical Devices Approved for Market Launch

Recently, the National Medical Products Administration has approved the registration applications for 2 innovative medical devices, which are:

The biologic knee joint prosthesis system of Just Medical (Tianjin) Co., Ltd. (hereinafter referred to as: Just Medical);

The magnetic resonance imaging system of Siemens Healthineers Ltd. (hereinafter referred to as "Siemens Healthineers").

Image Source: NMPA Official Website

Just Medical
Biological Knee Joint Prosthesis System

Just Medical was founded in 1958, originally known as Tianjin Orthopedic Medical Device Factory. Since its establishment, Just Medical has always focused on the field of joint diseases. According to the official website of Just Medical, its current product pipeline covers six major categories: AI products, new interface prosthetics, knee joint reconstruction, hip joint reconstruction, partial joint replacement, and regenerative repair.

According to the PharmCube Medical Device Data query, Just Medical currently has 21 approved and marketed products, with a significant number of non-powered implantable devices among them. From the trend of initial product registrations, the number of registered products has been increasing dramatically year by year, reaching a peak in 2024 compared to recent years.

Image Source: PharmCube Medical Device Data

The product approved for marketing this time is another innovative achievement of Just Medical. According to the NMPA, this product is used as a non-cemented prosthesis and is suitable for primary total knee arthroplasty. It consists of a femoral condyle, tibial plateau, tibial insert, positioning post, and compression rod. The materials of these five main components are also quite commendable:

The femoral condyle component is made of cast cobalt-chromium-molybdenum alloy material conforming to the YY 0117.3 standard, with a plasma-sprayed pure titanium coating on the inner surface.

The tibial plateau component is made from Ti6Al4V ELI powder using an electron beam melting additive manufacturing process;

The tibial plateau pad component is made of highly cross-linked ultra-high molecular weight polyethylene (grade Chirulen® 1020EX) material containing vitamin E.

The positioning column and compression rod components are made of TC4 titanium alloy material conforming to the GB/T 13810 standard.

Moreover, it is worth mentioning that the biological knee joint prosthesis system utilizes Just Medical's 3D printing technology and features self-compression mechanical stabilization technology. Compared with traditional cemented prostheses, this product is safer for the human body, not only free from the allergy risks associated with traditional products, but also effectively reducing the incidence of venous thrombosis and aseptic loosening.

According to the PharmCube Medical Device Data query, among the currently approved knee joint prosthesis systems on the market, Just Medical has a relatively high number of approved products. It can also be seen from the approved companies that the innovative R&D capabilities of China's medical device enterprises are further increasing, with more and more locally produced high-end medical devices being approved.

Image Source: PharmaSmart Medical Data

Siemens Healthineers
Magnetic Resonance Imaging System

It is understood that Magnetic Resonance Imaging (MRI) is an advanced modern medical imaging technology. This technology uses the principle of nuclear magnetic resonance to create images, providing a direct view of tissues and organs with unique advantages such as no radiation and non-invasiveness. Currently, MRI equipment can be divided into three main types: normal conducting, permanent magnet, and superconducting. Compared with other imaging products, MRI equipment can scan a wider range of body parts, making it relatively more expensive.

However, driven by factors such as the growing health awareness among the population and the continuous advancement of medical technology, the market share of MRI equipment is also steadily increasing. According to publicly available data, the market size of MRI equipment in China reached 16.6 billion yuan in 2024, with a compound annual growth rate of 5.3%. It is projected that by 2030, the market size will exceed the 20 billion yuan mark, reaching 22.8 billion yuan.

The magnetic resonance imaging system approved for listing by Siemens Healthineers this time consists of a 7T superconducting magnet, gradient system, radio frequency system, RF coils, workstation, physiological signal gating system, examination table, and electronic cabinet, and is mainly used for clinical MRI diagnostic imaging.

According to the NMPA, this product utilizes deep learning technology and adds a static-dynamic multi-channel transmission platform and multinuclear imaging functions based on a 7T high-field magnetic resonance imaging system. It can provide sodium images of the head, phosphorus spectrum data of limbs muscles, and liver. Moreover, the product leverages the advantages of multi-channel and multinuclear imaging to achieve real-time image adjustment, which can effectively enhance the imaging diagnostic efficiency for central nervous system diseases and improve the treatment level of corresponding diseases.

According to the PharmCube medical device data query, nearly 200 magnetic resonance imaging systems have been approved for marketing in China. By 2025, six domestically produced magnetic resonance imaging systems and one imported magnetic resonance imaging system will have been approved. Among the approved products, most of the currently approved magnetic resonance imaging systems are superconducting magnetic resonance imaging systems, with up to 145 such products available.

Image Source: PharmCube Medical Device Data

Currently, in terms of MRI equipment, domestically produced devices account for 88.6%, while imported ones make up only 11.4%. The localization process is continuously advancing, with an increasing number of locally produced devices being implemented.

Image Source: Pharmcube Medical Device Data

However, it is worth noting that, according to publicly available data, the current market share of MRI equipment is still occupied by foreign brands. Siemens Healthineers remains the top player in terms of market share, and the product recently approved is also an innovative achievement of Siemens Healthineers, which is accelerating its iterative innovation. In addition, local medical device companies are also continuously increasing their pace of innovation. In the MRI equipment market share, United Imaging Healthcare has shown particularly outstanding performance in 2024, with its market share experiencing significant growth, making it the second-largest player in the MRI equipment market.

With the continuous advancement of bulk procurement work across China and favorable factors such as policy support, the market share of locally produced MRI equipment companies will experience further growth.

Conclusion

Currently, the number of innovative medical devices approved in China has reached 364, and the number of medical devices entering the innovation channel continues to grow. The strength of domestically produced products is on the rise, and an increasing number of innovative achievements are beginning to emerge.

References:
Just Medical Official WeChat, Official Website

Editor: Muyan

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