Injectable fillers for plastic surgery are widely used in the field of aesthetic plastic surgery, and their safety and effectiveness are of vital importance. To ensure the safety and effectiveness of the products, it is indispensable to conduct scientific, rigorous, comprehensive and standardized preclinical physicochemical evaluations. According to the raw materials, injectable fillers for plastic surgery can be classified into sodium hyaluronate type, collagen type and polyester type, etc. The evaluation items and indicators for different materials vary. Preclinical physicochemical evaluations not only include general physicochemical project evaluation, such as the content of active ingredients, pH value, osmotic pressure, total heavy metal content, trace elements, etc., but also need to carry out corresponding evaluation items according to the particularity of different materials, such as the crosslinking degree of sodium hyaluronate gel, the collagen content of collagen products and the copolymerization rate of polyester products. This article not only briefly introduces the test methods of some general evaluation items, but also provides detailed introductions to some evaluation items that have no mature methods or have room for improvement in existing methods, aiming to provide references for the research and development and quality control of injectable fillers for plastic surgery, and help improve the safety and effectiveness of injectable fillers for plastic surgery.

To address the limitations of existing auricular vagus nerve stimulators, which have a single stimulation mode and are open-loop, a new type of auricular vagus nerve stimulator system was developed. Based on the programmable general-purpose stimulator chip ENS001 and the integrated analog front-end chip ADS1299, an auricular vagus nerve stimulator capable of multi-channel EEG signal acquisition, multiple stimulation waveforms, and multiple stimulation modes was designed and developed. The auricular vagus nerve stimulator, upon receiving parameter configuration instructions from the host computer, can generate four-channel output stimulation pulses with three types of waveforms and four modes (with an amplitude resolution of 0.1 mA, a frequency resolution of 1 Hz, and a pulse width resolution of 100 µs). The stimulator meets the requirements for the acquisition of human bioelectric signals and is capable of accurately acquiring human EEG signals. The auricular vagus nerve stimulator is simple in structure, low in manufacturing cost, portable, and has a wide range of adjustable stimulation parameters, showing great potential for application.

Under the U.S. medical product regulatory framework, innovative medical devices used in conjunction with approved drugs for new usage will often raise regulatory issues. To address these regulatory challenges and foster industry innovation, the FDA has proposed a new regulatory pathway. This paper traces the regulatory journey and risk analysis of the FDA in approving new uses of optical imaging agents and contrast agents through the medical device regulatory pathway. On this basis, it discusses the FDA's efforts to expand this pathway to broader applications and analyzes the reasons behind its lack of success. Finally, it discusses the current regulatory status of similar products in China, suggesting that this regulatory pathway may have certain implications for the regulation of similar products in China.

In order to support the demonstration application of domestic innovative medical device magnetocardiography (MCG) in China and promote the systematic display and promotion of clinical diagnosis solutions, this paper designs and constructs a networked, intelligent and standardized information service system of MCG diagnosis technology for coronary microvascular dysfunction. In response to the functional and performance requirements of the system, an efficient and scalable architecture is designed, which is based on the Node.js, supported by the React (frontend) and NestJS (backend) frameworks, and JSON Web Token (JWT) authentication. This architecture enables efficient and convenient data sharing and information exchange among multiple medical institutions. Currently, the system has provided demonstration, promotion, and resource integration of MCG clinical diagnostic solutions for 10 hospitals, with a cumulative collection of 845 case report forms (CRF). It provides technical support for the clinical diagnostic solution of homegrown innovative MCG in coronary microvascular dysfunction from the perspectives of information platform and service.

The digital surgical suction system integrates Intelligent digital technologies, features rapid iterations, and has complex components and high control accuracy requirements, which puts forward higher requirements for product quality control and medical device quality management system certification. This study puts forward the key points for quality management system certification in manufacturing of such products through the analysis of the technical characteristics and product life cycle risk of digital surgical suction system, combined with the requirements of ISO 13485:2016 medical device quality management system for regulations. It has certain reference significance for the quality management of enterprises and the medical device quality management system audit of certification bodies.

miRNA is a class of non-coding small RNAs with significant regulatory functions, capable of influencing various biological processes by modulating post-transcriptional translation. In recent years, the application of miRNAs as biomarkers in in vitro diagnostics (IVD) has garnered considerable attention. Firstly, this article introduces the generation and functional mechanisms of miRNAs, and outlines the roles and potential of miRNAs as biomarkers for various diseases, drawing on recent research findings. Subsequently, five traditional miRNA detection techniques are briefly introduced, their advantages and limitations in clinical diagnostic applications are summarized, and two emerging techniques used in miRNA research are enumerated. Finally, the article analyzes the challenges faced by using miRNAs as biomarkers in current clinical diagnostics, addressing four aspects: intended use, reference intervals, testing procedures, and analytical performance.

This study aims to predict the demand for coronary stents based on different deep learning models, in order to optimize the supply plan of coronary stents and improve the efficiency of supply and use. The centralized procurement data of coronary stents in a large tertiary hospital from January 2022 to August 2024 are selected, three deep learning models are used to predict the demand, the learning effect of the model is evaluated based on the MSE curve, and the prediction results of the dataset through different evaluation indicators are verified and the prediction error is evaluated. The MSE curve indicates that the Transformer model exhibits the strongest feature extraction and pattern recognition capabilities in this task, and the predicted demand evaluation index system verifies that the prediction results based on the Transformer model are close to the actual values. This study has established a deep learning based coronary stent supply model, which effectively predicts the demand for coronary stents and provides reference for optimizing hospital stocking plans, thereby ensuring the use and supply of coronary stents.

With the widespread application of 3D printing technology in the field of orthopedic implants, 3D-printed interbody fusion cages have attracted increasing attention. This article systematically reviews the latest research progress from two main aspects: materials and manufacturing processes, as well as structural design. Titanium alloys and polyetheretherketone are the most widely used materials, while novel composite and bioresorbable materials have further expanded the diversity of applications. In the future, optimization of material properties and improvements in manufacturing processes will be needed to achieve better clinical outcomes. 3D printing technology has promoted the diversification of fusion cage structural design, showing a trend toward "de-solidification". However, the optimal design parameters for porous structures still require further research to balance mechanical properties and osseointegration requirements.

With the widespread application of medical device software in clinical diagnosis and treatment, the accuracy and reliability of graphics measurement functions, which are core modules of medical device software, directly impact the quality of medical decision-making. However, the current lack of standardized testing methods both domestically and internationally has led to inconsistencies in verification approaches and testing protocols. Addressing the standardized testing requirements for graphics measurement functions in medical device software, this study systematically analyzes the common characteristics of these measurement functions. Based on the black-box testing methodology and a digital phantom-based standardized testing framework, it constructs a testing indicator system encompassing functional applicability and accuracy, while designing preparation methods for digital phantoms and traceability validation processes. The standardized testing method developed in this study fills a critical gap in the standardization of testing methods for this domain. It provides quantifiable technical criteria for the regulatory review and quality verification of graphics measurement functions in medical device software. This advancement contributes to enhancing the clinical safety of medical software and ensuring regulatory consistency.

Digital therapeutics, as a clinically evidence-based medical intervention driven by software programs, have shown immense potential in the early screening, diagnosis, management, and rehabilitation of cardiovascular diseases. This article firstly succinctly outlines the advantages of digital therapeutics in real-time monitoring, personalized and precise management, improving adherence, and optimizing healthcare resources. And then it systematically analyzes the relevant research findings and clinical application value of digital therapeutics in common cardiovascular diseases. Additionally, it delves into the challenges of evidence-based practices, regulation, and data security, and proposes strategies to address these issues, considering patient experience, medical practice, and ethical and legal concerns. The goal is to further promote the role of digital therapeutics in the treatment of cardiovascular diseases and provide new pathways for constructing an efficient, accessible, and secure digital diagnosis and treatment system.