[Concerns of Technical Evaluation on Registration of Disposable Endoscopic Injection Needle].

From the point of the technical evaluation of the registration of medical devices, the technical evaluation focus of the disposable endoscopic injection needle registration are briefly described in the chapters of the application overview documents, risk management data, product technical requirements, research data, toxic substance residues, biocompatibility evaluation, clinical evaluation data, et al. The common terms of technical requirements are specified, risk management and research materials list the project requirements for product characteristics. So as to accurately judge the product quality, improve the review efficiency, promote the development of the industry.

[Analysis of Revision Content and Evaluation Attentions on ()].

This study briefly introduces the revised content of () compared to the original guidance, mainly including the principles of dividing registration unit, main performance indicators of standard specification, physical and mechanical performance research, and clinical evaluation. At the same time, in order to provide some references for the registration of metallic bone plate internal fixation system, this study analyzes the main concerns in the review process of these products based on the accumulation of experience combining with the current review requirements.

[Study of Typical Functional Failure and Mechanical Properties of Non-absorbable Suture Anchor].

Objective: To study the mechanical properties related to the typical functional failure modes of non-absorbable suture anchor in clinical use, and to support product design, development and verification.

Methods: By retrieving the database of relevant adverse events, the typical functional failure modes of non-absorbable suture anchor were summarized, and the influencing factors of functional failure were further analyzed by studying the mechanical properties related to functional failure. The publicly available test data was retrieved for verification and provided reference for the researchers.

Biomimetic polymeric transcatheter heart valve leaflets with low calcification and good regenerative ability.

Transcatheter aortic valve replacement (TAVR) technology is quickly advancing in clinic, however, as it expands to low-risk populations and younger patients (age <65 years), device durability is becoming a major challenge. Tissue-engineered heart valves (TEHVs) are a potential alternative. In this study, a bionic tri-layer tissue-engineered heart valve was constructed using poly (L-lactate--ε-caprolactone) (PLCL), gelatin (GEL), hyaluronic acid (HA) and silk fibroin (SF), to simulate the fibrosa, spongiosa and ventricular layer of natural heart valves.

Ultrasonic/electrical dual stimulation response nanocomposite bioelectret for controlled precision drug release.

Electret materials have attracted extensive attention because of their permanent polarization and electrostatic effect. However, it is one of problem that needs to be solved in biological application to manipulate the change of surface charge of electret by external stimulation. In this work, a drug-loaded electret with flexibility and no cytotoxicity was prepared under relatively mild conditions.

[Consideration of Supervision of Mesotherapy Needles for Cosmetic Injection].

With the development of medical aesthetics industry in China, sodium hyaluronic is injected into the facial dermis with multi needles to relieve wrinkles, thick pores, skin relaxation and other aging problems, is more and more popular nowadays. The wide application of mesotherapy for cosmetic injection and the subsequent adverse events are widely reported. This study attempts to explore the adverse events and countermeasures for the application of mesotherapy from the perspective of medical device supervision.

Reinforcing supramolecular hyaluronan hydrogels via kinetically interlocking multiple-units strategy.

Supramolecular hydrogels exhibit promising potential in biological and clinical fields due to their special dynamic properties. However, most existing supramolecular hydrogels suffer from poor mechanical strength, which severely limits their applications. Here in this study, the Kinetically Interlocking Multiple-Units (KIMU) strategy was applied to the hyaluronan networks by introducing different supramolecular interaction motifs in an organized and alternative manner.

Anti-Alzheimer's Natural Products Derived from Plant Endophytic Fungi.

Alzheimer's is the most common cause of dementia worldwide and seriously affects patients' daily tasks. Plant endophytic fungi are known for providing novel and unique secondary metabolites with diverse activities. This review focuses primarily on the published research regarding anti-Alzheimer's natural products derived from endophytic fungi between 2002 and 2022.

Establishment and Application of a Patient-Ventilator Asynchrony Remote Network Platform for ICU Mechanical Ventilation: A Retrospective Study.

Background: In the process of mechanical ventilation, the problem of patient-ventilator asynchrony (PVA) is faced. This study proposes a self-developed remote mechanical ventilation visualization network system to solve the PVA problem.

Method: The algorithm model proposed in this study builds a remote network platform and achieves good results in the identification of ineffective triggering and double triggering abnormalities in mechanical ventilation.

[Discuss Application of Real-world Data from the Boao Lecheng Pilot Zone to Support Premarket Clinical Evaluation of Medical Device].

The real-world data of Hainan Boao Lecheng International Tourism Pilot Zone has the advantage of supporting pre-market clinical evaluation of medical devices. Based on the relevant requirements of clinical evaluation of medical devices and based on the practical experience of pilot devices in the early stage, the application of Boao Lecheng real-world data in the pre-market clinical evaluation path of medical devices from the perspective of review is discussed. At the same time, the elements that should be considered in real-world study design and the way of data quality evaluation are proposed.

Superhydrophilic and topography-regulatable surface grafting on PEEK to improve cellular affinity.

Polyetheretherketone (PEEK) has been widely used in the preparation of orthopedic implants due to its biological inertness and similar mechanical modulus to natural bone. However, the affinity between biological tissue (bone and soft tissue) and PEEK surface is weak, leading to low osseointegration and an increased risk of inflammation. The situation could be improved by modifying PEEK surface.

Plain metallic biomaterials: opportunities and challenges.

The 'plainification of materials' has been conceptualized to promote the sustainable development of materials. This perspective, for the first time in the field of biomaterials, proposes and defines 'plain metallic biomaterials (PMBs)' with demonstrated research and application case studies of pure titanium with high strength and toughness, and biodegradable, fine-grained and high-purity magnesium. Then, after discussing the features, benefits and opportunities of PMBs, the challenges are analyzed from both technical and regulatory aspects.

Phase Contrast Image-Based Rapid Antimicrobial Susceptibility Testing of Bacteria in Liquid Culture Media.

Currently, the world is facing the problem of bacterial resistance, which threatens public health, and bacterial antimicrobial susceptibility testing (AST) plays an important role in biomedicine, dietary safety and aquaculture. Traditional AST methods take a long time, usually 16-24 h, and cannot meet the demand for rapid diagnosis in the clinic, so rapid AST methods are needed to shorten the detection time. In this study, by using an in-house built centrifuge to centrifuge bacteria in a liquid medium onto the inner wall of the bottom surface of a counting plate, and using a phase contrast microscope to track bacterial growth under the effect of different antibiotic concentrations, the results of the minimum inhibitory concentration (MIC) of bacteria under the effect of antibiotics can be obtained in as early as 4 h.

[Analysis of International Standard ISO 80601-2-90:2021 for High-flow Respiratory Therapy Equipment].

The international standard ISO 80601-2-90:2021 specifies basic safety and essential performance requirements, including risks associated with oxygen, flow accuracy, oxygen concentration accuracy, humidification output performance, and corresponding test methods for high-flow respiratory therapy equipment. This study focuses on the key points in ISO 80601-2-90:2021 and the key problems in the test evaluation. This study also briefly introduces the relationship between ISO 80601-2-90:2021 and other standards, and explains the countermeasures that stakeholders should take.

[Discussion on Key Attention in Technical Review for Additive Manufacturing Acetabular Reconstruction Implantable Device].

With the development of additive manufacturing, the advantages of this type implant devices in the treatment of acetabular defects and reconstruction are becoming more and more prominent. The number of registration and declaration of such products is increasing day by day. According to the relevant requirements of the National Medical Products Administration for registration and application documents, combined with the characteristics of acetabular reconstruction implant products made of additive manufacturing, this study analyzes and summarizes the relevant requirements on raw material control, product performance research, product manufacturing, clinical evaluation, et al.

[Analysis of Common Questions in Medical Device Technical Review].

Risk management is an activity running through the full life of medical device, which has a significant effect on ensuring the safety and effectiveness of medical device. Many researchers do the research on medical device risk management from different perspectives, but few people discuss it from the technical perspective. The risk management issue in technical review of medical equipment was discussed, the reasons of the issue were analyzed, and suggestions were given in this study.

Quality of reporting and adherence to the ARRIVE guidelines 2.0 for preclinical degradable metal research in animal models of bone defect and fracture: a systematic review.

testing is crucial for the evaluation of orthopedic implant efficacy and safety. However, the translation and reproducibility of preclinical animal experiments are not always satisfactory, and reporting quality is among the essential factors that ensure appropriate delivery of information. In this study, we assessed the reporting quality of investigations that examined the use of degradable metal materials in fracture or bone defect repair.

[Research on the current situations of reliability and evaluation in Chinese active medical device industry].

Active medical device is a kind of medical device which is widely used. In order to realize the goal of high-quality development, product with high reliability is a necessary requirement for the domestic active medical device industry. By means of literature research, data collection, field research, materials comprehensive combing and analysis, this paper systematically analyzes and studies the current situations and the existing problems of reliability and evaluation from the dimensions of Chinese active medical device industry policy, enterprise situation and evaluation method.

[Ideas and Briefing about Regulatory Requirements for Laboratory Developed Tests in the US].

As a special kind of diagnostic devices（IVDs）, laboratory developed tests（LDTs） are of great significance to the development of clinical laboratories. This study aims to explore the regulatory requirements ideas of LDTs. By introducing the development of LDTs and the changing of regulatory requirements in the United States, combing the current regulatory framework and discussing relevant ideas in the regulatory requirements of LDTs.

Design, development and evaluation of an ergonomically designed dual-use mechanism for robot-assisted cardiovascular intervention.

Purpose: Robot-assisted cardiovascular intervention has been recently developed, which enables interventionists to avoid x-ray radiation and improve their comfort. However, there are still some challenges in the robotic design, such as the inability of the interventionist to freely perform natural clinical techniques and the limited motion travel of the interventional tool. To overcome these challenges, this paper proposes an ergonomically designed dual-use mechanism for cardiovascular intervention (DMCI).

Functionalization of biomedical materials using fusion peptides for tissue regeneration.

Tissue development deformity or tissue defect is a major clinical challenge. Tissue engineering technology provides a promising solution to these problems. Among them, functional biomaterials with regenerative abilities are one of the development trends.

Microbiosis in lung allotransplantation and xenotransplantation: State of the art and future perspective.

The respiratory tract is known to harbor a microbial community including bacteria, viruses, and fungi. New techniques contribute enormously to the identification of unknown or culture-independent species and reveal the interaction of the community with the host immune system. The existing respiratory microbiome and substantial equilibrium of the transplanted microbiome from donor lung grafts provide an extreme bloom of dynamic changes in the microenvironment in lung transplantation (LT) recipients.

Development of a multi-recombinase polymerase amplification assay for rapid identification of COVID-19, influenza A and B.

The coronavirus disease 2019 (COVID-19) pandemic caused extensive loss of life worldwide. Further, the COVID-19 and influenza mix-infection had caused great distress to the diagnosis of the disease. To control illness progression and limit viral spread within the population, a real-time reverse-transcription PCR (RT-PCR) assay for early diagnosis of COVID-19 was developed, but detection was time-consuming (4-6 h).

[Consideration on Animal Experiment in PET/CT].

PET/CT imaging can reflect the physiological metabolic process in living body which is the model experiment incapable to simulate. Animal experiment may be considered for systematic validation of PET/CT products. The obtained research data can be used to evaluate the feasibility, effectiveness and safety of PET/CT products, and be submitted as supporting documents for research data or clinical evaluation data when doing product registration or alteration registration.