On September 3rd, the National Medical Products Administration announced that it has recently approved the registration applications for two innovative products, the "Navigation Positioning Microwave Ablation System" of True Health (Zhuhai) Medical Technology Co., Ltd. (hereinafter referred to as "True Health Medical") and the "Hepatitis B Virus Surface Antigen (HBsAg) Detection Kit (Chemiluminescence Method)" of Fuji Ruibiou Co., Ltd. (hereinafter referred to as "Fuji Ruibiou").

True Health Medical: International First Product
Founded in 2018, True Health Medical is a national high-tech enterprise specializing in the research and production services of surgical robots. Based on artificial intelligence technology, it integrates intelligent robot systems into the diagnosis and treatment process through the close integration of industry, academia, research, and medicine, achieving a comprehensive medical technology system with precise puncture of soft tissue lesions throughout the body as a diagnostic and treatment method. Precise puncture is a means to deliver minimally invasive treatment drugs and equipment to the affected area, helping to detect and diagnose diseases early and achieve minimally invasive precision treatment.

True Health Medical has obtained the first Class III medical device registration certificate and production license in the field of soft tissue puncture surgery robots, and pioneered the "puncture surgery navigation and positioning system" in China.

The navigation positioning microwave ablation system (microwave ablation surgical robot) approved this time is another groundbreaking surgical robot product launched by True Health Medical after the puncture surgical robot obtained the first certification in China.

This product consists of a main control trolley (including a robotic arm and foot switch), a microwave therapy trolley (including an optical tracking module and foot switch), a navigation and positioning tool, a microwave transmission line, a disposable microwave ablation needle, and a disposable temperature measuring needle. A needle insertion plan can be developed based on CT images before surgery, and a microwave ablation needle can be guided for percutaneous puncture surgery during surgery for microwave ablation of solid liver tumors in adults.

Compared with traditional microwave ablation equipment, the microwave ablation surgical robot innovatively integrates optical navigation and positioning technology, four-dimensional real-time registration technology, dynamic respiratory tracking technology, and microwave ablation technology of true health medicine. Equipped with a new generation of artificial intelligence platform, it effectively improves the accuracy, success rate, and surgical efficiency of clinical microwave ablation needle placement and lesion target area ablation, reduces the requirements for doctors' puncture and ablation planning experience, significantly improves the effectiveness and safety of puncture ablation treatment, and is recognized by the National Medical Products Administration as an "international first".

It is worth mentioning that this is the third surgical robot NMPA Class III certificate approved by True Health Medical, and also the second product to receive the "Innovation Certification".

Fuji Ruibiou: Innovative Testing Kit
Fujirebio is an in vitro diagnostic company founded in 1950. It is a leading enterprise in immunology testing in Japan, with numerous innovative and unique projects in fields such as oncology and infectious diseases. It has provided a variety of products and services to more than 100 countries and regions.
It is reported that the approved hepatitis B virus surface antigen (HBsAg) detection kit consists of antibody binding particles, enzyme labeled antibodies, and sample processing solution. It is used for qualitative and quantitative detection of hepatitis B virus surface antigen (HBsAg) in human serum or plasma in vitro.
The quantitative detection of hepatitis B B virus surface antigen has many special significance. It is the most important serological marker of acute and chronic hepatitis B B virus infection. It can identify inactive chronic hepatitis B virus (HBV) carriers, predict the clearance rate of HBsAg, predict the risk of hepatocellular carcinoma, predict and evaluate the efficacy of antiviral treatment such as interferon therapy.
However, the hepatitis B virus has a high mutation rate. In recent years, the use of antiviral drugs, hepatitis B immunoglobulin and hepatitis B vaccine has led to an increase in the probability of mutation of viral nucleic acid and the production of HBV mutants, which can escape the host's immune defense, leading to clinical treatment failure, and also bringing challenges to the serological detection of hepatitis B virus.
The approval of this innovative product is a new "milestone" for quantitative detection of hepatitis B virus surface antigen. Compared with similar products already on the market, this product has higher sensitivity, and can detect the corresponding antigen when the concentration of hepatitis B virus surface antigen in the blood is low at the initial stage of infection of hepatitis B virus infected persons, so as to realize early diagnosis and early treatment.

As an integral part of clinical technology, medical devices have always been developing towards standardization, intelligence, and precision. At present, innovative medical devices will be increasingly applied in the fields of technology assistance and automation to help healthcare workers improve efficiency and accuracy, reduce medical risks and operational difficulties.

Based on this, China's innovative medical device approval channels and the number of products on the market continue to rise, with fruitful innovation achievements. The medical device industry is continuously accelerating towards the goal of high-quality development.

Source: https://news.yaozh.com/archive/44151.html