Activity

It provides reference for accurate and efficient supervision of medical artificial intelligence industry.

By summarizing the main responsibility dilemma of medical artificial intelligence diagnosis products, sorting out relevant researches at home and abroad, the primary responsibility system of medical artificial intelligence diagnosis products is constructed.

A medical artificial intelligence diagnosis products primary responsibility system with the marketing authorization holder as the “first responsible person” is established, and three safeguard measures are proposed, namely, algorithm transparency and interpretability, classification supervision mode and social co-governance supervision mode.

The medical artificial intelligence diagnosis products primary responsibility system is helpful to implement the primary responsibility, to build “responsible and beneficial” artificial intelligence, and to realize “self-discipline”, “good governance” and “in good order”.

The medical artificial intelligence diagnosis products primary responsibility system is helpful to implement the primary responsibility, to build “responsible and beneficial” artificial intelligence, and to realize “self-discipline”, “good governance” and “in good order”.IMDRF revised the Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices (hereinafter referred to as “EP”), which further promoted the unification of medical device safety and effectiveness internationally. In order to strengthen the scientific review of medical device and deepen the understanding of EP, we introduce EP, focus on the role of EP and the connection with the construction of quality management systems, risk and benefit determination, and registration, analyze the problems and reasons in the process of medical device registration, and give suggestions to promote the application of EP.Polymer hydrophilic lubricating coatings for medical catheters refer to highly hydrophilic coating films fixed on the surface of catheters with binding force, which can reduce the surface friction with human tissues during the use of interventional catheters, improve the patient comfort of and effectively reduce the incidence of infection. Based on the development process of medical catheter coating, this review summarizes recent advances in the field of polymer hydrophilic lubricating coatings for medical catheters from types of hydrophilic coating polymer, development of coating technology and establishment of coating performance evaluation method. Main problems in this field are analyzed and development trends in the future are prospected.It is well known that chitosan-based composites are widely used in implantable medical devices. The development of chitosan-based composite materials with different types was summarized in this paper, such as inorganic, organic and composite phases. Then, combined with the research focus, the development of 3D printing technology and chitosan-based composites was summarized. It was also pointed out that the existing problems in our research, which need to be solved urgently. At last, the development direction and broad application prospect of chitosan-based composites were prospected. And we look forward to providing reference for relevant research.In recent years, the application of stent intervention in the treatment of non-vascular stenosis caused by benign and malignant factors has been widely concerned by researchers at home and abroad. The high incidence of malignant tumor diseases, further promotes the development of stent intervention. The conventional bare stents are prone to irritate luminal mucosa and produce restenosis and other complications. The emergence of drug-eluting stent is expected to solve this problem and become one of the important development trends of non-vascular stents. In this paper, the drug loading materials, drug loading layer drugs, preparation technology and quality evaluation methods of non-vascular drugeluting stent are described based on the recent research and clinical application documents, so as to provide basis and direction for the follow-up research and development.Operation room is the most important link for carrying out medical activities in hospital whose demand for medical consumable material is also very large. With the increase of types of consumable material, the process of consumable material management in operating room becomes more complicated, and the traditional management mode can not meet the needs. U0126 In this paper, the technology of Internet of things and artificial intelligence is used to design an intelligent management system of high value consumable material in operating room which improves the efficiency of operation of high value consumable material in operating room, reduces the cost of manpower and improves the safety.This paper introduced a liver normothermic machine perfusion repair and assessment system. This system consists of a liver normothermic machine perfusion device, a fluorescence imaging system and a tissue oxygen detector. The normothermic machine perfusion device can continuously perfuse the donor liver and monitor and control the perfusion parameters in real time. The fluorescence imaging system can detect the indocyanine green metabolized by the liver to evaluate the microcirculation and the metabolism function of hepatocytes. The tissue oxygen detector can monitor the change of oxygen partial pressure of liver tissue in real time to evaluate the state of cell oxygen consumption.The magnetic anchoring lung nodule positioning device is composed of a target magnet, an anchor magnet, a coaxial puncture needle and a puncture navigation template, through these, a new type of accurate positioning technology for small pulmonary nodules is derived. The device inserts the target magnet into the both sides nearby the lung nodule under the guidance of CT. Helped by the mutual attraction of the two target magnets, they can be fixed in the lung tissue, avoiding the movement in the lung, and accurately positioning the target lung nodule before surgery. In thoracoscopic surgery, the anchor magnet and the target magnet attract each other to achieve the purpose of positioning the target nodule. The device uses the characteristics of non-contact suction of magnetic materials biomedical engineering technology, eliminating the previous procedure of direct interaction with the positioning marks, finally achieves the target of precise positioning of lung nodules and rapid surgical removal.