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 To observe the rules of medication and clinical application of Zhongwan(RN12)point,thus to provide reference for the selection of acupoints in clinical treatment.Methods Collect the Zhongwan point-involved prescriptions in the literature of the last 20 years in China National Knowledge Infrastructure(CNKI),China Science and Technology Journal Database(VIP)and Wanfang Data Knowledge Service Platform,conduct strict screening,organize and record all the acupoints involved in the prescriptions,of which met the acupoint selection criteria,into Excel tables,then use IBM SPSS Statistics 25.0 software,IBM SPSS Modeler 18.0 software,Cytoscape 3.10.1 software,apriori algorithm to analyze the rules of medication and clinical application of Zhongwan point.Results After screening,a total of 781 articles with 830 acupoint-involved prescriptions were included,involves 183 acupoints and 135 diseases.With the leading five acupoints which ranked in decending order of selection was as follows:Zusanli(ST36),Neiguan(PC6),Tianshu(ST25),Guanyuan(BL26)and Qihai(RN6).The distribution of acupoints with the highest frequency of use in combination acupoints was Zusanli(61.205%support),and the meridians with a higher frequency of use in Zhongwan point-involved prescriptions were the foot-yangming stomach meridian,the foot-taiyang bladder meridian,and the conception vessel(CV),with the combination acupoints dominated by the specific acupoints of Xiahe points,He points,front-Mu points,collateral points,Shu Points,and original points,the advantageous diseases were characterized by intractable hiccups,gastritis,functional dyspepsia and so on.Among them,the diseases pertain to the digestive system were the most involved,followed by endocrine system diseases.Conclusion The data mining analysis yielded that there are certain rules to be followed in the acupoints combination of Zhongwan point,and it exerts some efficacy in the treatment of certain advantageous diseases,which can provide references for clinical treatment and scientific research.

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 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.

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.

By summarizing the clinical use of different capsule endoscopes in small intestine,colon,stomach and esophagus,the relevant evaluation indicators of the clinical application of capsule endoscopes for patients with different diseases were sorted out.Combined with the review process of capsule endoscopes that have been marketed at home and abroad,the key points of clinical evaluation of capsule endoscopes products in China that need to be marketed through clinical trials were considered.The clinical evaluation focuses included main evaluation index,secondary evaluation index and safety evaluation index,and the main evaluation index could consider the consistency rate of lesion diagnosis results and the excellent rate of image quality.The inclusion criteria for clinical trials of capsule endoscopy products were the population who intended to use the product,and the exclusion criteria need to consider the circumstances that were not applicable to such products and the circumstances that were not applicable to enrollment.

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