[Objective]In order to explore the regulatory requirements for clinical evaluation about peripheral and pulmonary thrombus removal apparatus,the marketing status of these apparatuses in the Food and Drug Administration(FDA)of United States was searched,and the pre-marketing research contents of relevant documents were summarized and organized.Based on the current public information on their official website,the clinical trial designs of FDA's three main categories of peripheral and pulmonary thrombus removal apparatuses(aspiration catheter,thrombectomy stent and mechanical thrombus removal system)in 510(k)pre-marketing notice were sorted out,and the regulatory requirements of FDA clinical evaluation about this kind of apparatus were analyzed,which could provide references for researchers and developers of relevant products,and clinical researchers about the pre-marketing clinical evaluation of peripheral blood thrombolysis apparatus.

BACKGROUND:3D organoids have characteristics that resemble physiological tissues and to some extent mimic organ function,making them excellent models for applications ranging from basic development/stem cell research to personalized medicine. OBJECTIVE:To review and discuss the types of diseases and application areas such as tumor modeling that organoids can be applied to,as well as their regulatory status and challenges. METHODS:With"organoid,stem cell,disease model,3D printing technology,medical field"as Chinese and English search terms,we searched PubMed,Elsevier,WanFang,and CNKI databases to summarize and analyze organoid products at home and abroad,summarize the application of organoid technology in the medical field,and prospect the future development of organoid products in the medical field. RESULTS AND CONCLUSION:Organoids can break the limitations of traditional cell and animal models,avoid the ethical problems existing in clinical research,and have a high similarity to the source organ,a more similar performance to the physiology and pathology of human systems,and genetic stability,which has great advantages in current research.Organoids have been applied in the following fields:efficacy evaluation studies(preclinical models),including intestinal organoids,kidney organoids,liver organoids,gallbladder organoids,lung organoids,brain organoids,heart organoids,skin organoids,and reproductive system organoids;research on infectious diseases;cancer research and precision therapy;regenerative medicine;immune organoids.Although the United States,the European Union and China do not have perfect regulatory provisions,they are trying to promote the formulation of organoid regulatory laws and regulations.In China,although no organoid medical device products have been listed for the time being,its related regenerative medicine products have made breakthroughs.

[Objective]In order to explore the regulatory requirements for clinical evaluation about peripheral and pulmonary thrombus removal apparatus,the marketing status of these apparatuses in the Food and Drug Administration(FDA)of United States was searched,and the pre-marketing research contents of relevant documents were summarized and organized.Based on the current public information on their official website,the clinical trial designs of FDA's three main categories of peripheral and pulmonary thrombus removal apparatuses(aspiration catheter,thrombectomy stent and mechanical thrombus removal system)in 510(k)pre-marketing notice were sorted out,and the regulatory requirements of FDA clinical evaluation about this kind of apparatus were analyzed,which could provide references for researchers and developers of relevant products,and clinical researchers about the pre-marketing clinical evaluation of peripheral blood thrombolysis apparatus.

A variety of facial injection filler materials have been approved for market at home and abroad.The marketing approvals,clinical application literature,expert consensus or clinical application guidelines of facial injection filler products at home and abroad were collected and it was found that facial injection filler materials may cause a number of adverse reactions.The clinical application and adverse reactions of facial injection filler materials were summarized,the pre-market adverse reaction evaluation requirements of such products in the United States and China were analyzed and summarized,aiming to provide reference for relevant product developers and clinical researchers to evaluate the pre-market adverse reactions of facial injection filler materials.

BACKGROUND:Additive manufacturing technology provides strong technical support for personalized and precise medical treatment due to its rapid prototyping,digitalization,and personalization.Therefore,its medical devices have developed rapidly in orthopedics,oral,preoperative planning,craniomaxillofacial,and other clinical applications. OBJECTIVE:To briefly introduce the progress of additive manufacturing technology and its commercial application in the clinic in and outside China. METHODS:Wanfang Data,China National Knowledge Infrastructure(CNKI),PubMed,Elsevier,Springer Link databases,and the websites of National Medical Products Administration and FDA were searched using"additive manufacturing,medical device,clinical application,3D printing"as Chinese search terms and"additive manufacturing(AM),additive manufacturing technology,medical device,clinical application,3D printing"as English search terms.The search time ranged from January 2010 to March 2023,and a few classical long-term articles were included. RESULTS AND CONCLUSION:Additive manufacturing technology is classified by the form of raw materials(liquid-based,solid-based,and powder-based).At present,there are seven kinds of additive manufacturing processes,including fused deposition molding,stereo-curing molding,powder bed melting,directed energy deposition,binder jet 3D printing,inkjet printing,and layered solid manufacturing.The marketed additive manufacturing products include orthopedic products,dental products,preoperative planning guide plate/bone model products,and craniomaxillofacial products.The orthopedic products include matching long-segment bone defect restoration,interbody fusion cage,knee joint orthosis,vertebral prosthesis,thoracolumbar fusion matching prosthesis system,knee prosthesis,and hip prosthesis.Dental products include light-curing resin for additive manufacturing and BB Base 3D Printing Resin for Denture Base.The products of preoperative planning guide plates/bone models include bone models,medical orthopedic surgical guide plates,customized dental implant guide plates,and human organ models.The craniomaxillofacial products include polycaprolactone scaffolds,patient-specific skull implants,OsteoFab patient-specific face device,SpinFab VBR prosthesis,and TruMatch CMF titanium alloy 3D printing prosthesis system.

Objective Explore a non-contact physiological and psychological detection model based on facial video in simulations of weightlessness effects,research new methods for non-contact heart rate and negative mood state detection in long-term simulations of weightlessness effect analysis.Methods Construct a non-contact physiological and psychological data collection system for fusion analysis of visible light and thermal infrared videos.Collect physiological and psychological data of volunteers in the"Earth Star-Ⅱ"90-day head-down bed rest experiment.A non-contact heart rate detection model based on GCN facial multi-region feature fusion and a non-contact negative mood state detection model considering data reliability were constructed,and the effectiveness of the models were validated with finger clip heart rate and POMS-SF scale as labels.Results The experimental results show that the average difference in the Bland-Altman plot of the non-contact heart rate detection model is-1.26 bpm,and 96.3%of value error detection data falls within the 95%confidence interval,indicating a high consistency between the model detected heart rate and the finger clip heart rate.The non-contact negative mood state detection model achieves an accuracy of>0.85 for detecting tension,depression,anger,and fatigue.Features such as heart rate,AU06,eye gaze,and head pose were observed to be important to mood state detection.Conclusion Non-contact physiological and psychological detection methods not only can be utilized for long-term physiological analysis in simulations of weightlessness effects,but also provide a novel technical approach for on-orbit astronauts health assurance during long-term space flight in the future.

Objective The applications of personalized abutments and abutment crown bridge products have increased year by year,but there is no clear requirement for clinical evaluation of the same variety of such products.This study mainly introduces the clinical evaluation concerns of personalized abutments and abutment crown bridge products,in order to provide reference for the declaration and registration of such products.Methods The clinical evaluation of personalized abutments and crown bridge products are summarized,and the research content of clinical evaluation is clarified.Results The clinical evaluation requirements that need to be considered by enterprises are introduced.Conclusion Personalized abutment and abutment crown bridge products can refer to this study when they are launched in China,mainly using in vitro performance comparison tests for equivalence verification.

Objective:To construct an evaluation index system of perceived service quality for Internet hospitals, and to provide references for scientific evaluation and effective management of such hospitals′ service quality.Methods:Thanks to literature review and expert interviews, an index system was initially built based on the Brady and Cronin model.From August to November 2021, Delphi expert consultation method was used in three rounds of correspondence questionnaire survey, and experts were consulted to assess the importance, familiarity and judgment basis of these indexes. The importance of the indexes was expressed by ± s, and the weight value of each index was calculated using analytic hierarchy process fuzzy comprehensive evaluation method and SPSS Au software. Results:The evaluation index system of perceived service quality for such hospitals included 3 level-1 indexes, namely environmental quality, interaction quality and result quality; and 10 level-2 indexes, namely software platform, service support, social factors, attitude, behavior, professional quality, service effect, service efficiency, service cost, satisfaction; and 30 level-3 indexes. Among these indexes, result quality of level-1 indexes scored the highest weight value(0.337); Software platform, professional quality, service support and attitude of level-2 indexes scored a higher weight values, respectively 0.119, 0.119, 0.109 and 0.109. Of level-3 indexes, reputation of Internet hospitals, service attitude of their doctors and doctor-patient communication skills of doctors online scored a higher weight values, respectively 0.102, 0.057 and 0.055.Conclusions:The index system for Internet hospital perceived service quality evaluation built in this study proved scientific, contributing positively to guiding Internet hospitals to improve their quality and safety management.

From the perspective of technical evaluation, this article introduces the focus of clinical evaluation of dental implants (systems) in comparison with the comparable devices and discusses the clinical evaluation of such products，combined with the clinical evaluation review of dental implants (systems) products in recent years, in order to provide reference for the registration of these products.
Dental Implants

Children are a high-risk group of burn, and burn pain is a special type of pain. Because children of different ages have different cognitive ability and behavioral response to pain, thus it is particularly difficult to effectively evaluate the pain. It is very important for medical staff to understand the pain of children, to define the adverse reactions of pain, to evaluate and take appropriate pain intervention measures in time and effectively. In this paper, different evaluation methods of burn pain in children and non-drug intervention related measures were reviewed in order to provide references for clinical practice.