Devices In China Research Articles

Legal Regulation of Smart Wearable Devices in China

Legal Regulation of Smart Wearable Devices in China

Research Trends on the Human Anatomy Structure of Acupoints Using Imaging Devices in China

Research Trends on the Human Anatomy Structure of Acupoints Using Imaging Devices in China

The status of the AI medical industry in China: A database and statistical analysis

BackgroundArtificial intelligence (AI) technology has developed rapidly in recent years, leading to exponential growth in the AI medical industry. However, a comprehensive investigation of approved medical devices in China is needed. MethodsWe utilized a web crawler to collect data on all medical devices from the China National Medical Products Administration website since 2018. Through natural language processing techniques and manual analysis, we identified all medical devices developed by artificial intelligence medical devices (AIMD) companies and conducted a statistical analysis. ResultsSince 2018, the number of AI-related medical devices approved in China has significantly increased. Most devices (79 %) were classified as Class II with moderate risk, whereas 21 % were classified as Class III with high risk. Most devices (74.2 %) were categorized as medical device software, and the most common application was medical image processing (63.2 %). In terms of target body areas, devices related to the heart accounted for the highest proportion (12.8 %), followed by those related to the lungs (11.3 %) and brain (6.7 %). ConclusionThis study establishes a comprehensive database of medical devices developed by AIMD companies in China, enabling the public to gain a coherent understanding of their current development status.

Long-term outcomes of a novel fully magnetically levitated ventricular assist device for the treatment of advanced heart failure in China

PurposeLeft ventricular assist devices (LVADs) are well-established for treating end-stage heart failure, but this therapy is only available to Chinese patients in recent years. The CH-VAD is the first used fully magnetically levitated pump and the most widely used device in China. This study reports the long-term outcomes of a cohort supported by the CH-VAD for the first time. MethodsFrom June 2017 to August 2023, 50 consecutive patients received CH-VAD implantation in Fuwai Hospital. Clinical data were collected during follow-up and retrospectively analyzed. ResultsBaseline characteristics included a mean age of 47.9±13.9 years, 90% male, and 26% ischemic etiology. The INTERMACS profile revealed 12% Profile 1, 56% Profile 2, 26% Profile 3 and 6% Profile 4. Mean support duration was 868 ± 630 days (range 33 days-6.4 years). Kaplan-Meier survival rate was 96% (95% confidence interval [CI], 85 to 99) at 6 months, 93% (95% CI, 79-98) at 1 year, 93% (95% CI, 79-98) at 2 years and 89% (95% CI, 71-96) at 3 years. 40 patients (80%) currently remain on support, 3 were bridged to recovery, 2 received transplant, and 5 expired during support. Major adverse events included right heart failure (10%), surgical related bleeding (8%), arrhythmia (8%) and driveline infection (16%). Major hemocompatibility-related adverse events were limited to 3 non-disabling strokes and 1 gastrointestinal bleeding. There was no major device malfunction during the follow-up period. ConclusionsThe largest single-center experience with the leading LVAD in China shows high survival with low complication rates, demonstrating the CH-VAD is safe and efficient in providing long-term support for end-stage heart failure patients.

Analysis and prospects of the field of optical fiber materials and devices in China from the perspective of National Natural Science Foundation of China

Analysis and prospects of the field of optical fiber materials and devices in China from the perspective of National Natural Science Foundation of China

Tubridge flow diverter for the treatment of recurrent cerebral aneurysms

Background & Objective: The Tubridge flow diverter is a commonly used device in China for reconstructing the parental artery and occluding complex intracranial aneurysms. However, there is limited experience with the device in treating recurrent intracranial aneurysms. The purpose of this study is to assess the safety and effectiveness of the Tubridge flow diverter in treating recurrent single- coiling aneurysms. Methods: The clinical records of patients with recurrent intracranial aneurysms who were treated with a Tubridge flow diverter were reviewed to show the therapeutic process, occlusion rate, and clinical outcomes associated with this treatment method. Results: Five patients with recurrent aneurysms of the internal carotid artery after singe coiling were included in the study. The recurrent aneurysmal sac had a mean length and width of 8.34/4.30 mm. All five Tubridge flow diverters were implanted without any unfold failure. The last angiographic follow-up showed a complete occlusion rate of 100%. Five branch arteries were covered, and only one branch artery disappeared during follow-up. No cases of cerebral infarction or intracranial hemorrhage were found among the patients. Conclusions: Our initial findings indicate that the Tubridge flow diverter could be a reliable and successful method for treating recurring single-coil aneurysms. We observed that the branch arteries were well-preserved, and no patients experienced cerebral infarction or hemorrhage. However, further research is necessary to establish clear indications and potential complications through a multicenter randomized controlled trial with long-term follow-up.

Quantifying stakeholders' preference for implantable medical devices in China: a discrete choice experiment.

This study aims to gain insight into each attribute as presented in the value of implantable medical devices, quantify attributes' strength and their relative importance, and identify the determinants of stakeholders' preferences. A mixed-methods design was used to identify attributes and levels reflecting stakeholders' preference toward the value of implantable medical devices. This design combined literature reviewing, expert's consultation, one-on-one interactions with stakeholders, and a pilot testing. Based on the design, six attributes and their levels were settled. Among 144 hypothetical profiles, 30 optimal choice sets were developed, and healthcare professionals (decision-makers, health technology assessment experts, hospital administrators, medical doctors) and patients as stakeholders in China were surveyed. A total of 134 respondents participated in the survey. Results were analyzed by mixed logit model and conditional logit model. The results of the mixed logit model showed that all the six attributes had a significant impact on respondents' choices on implantable medical devices. Respondents were willing to pay the highest for medical devices that provided improvements in clinical safety, followed by increased clinical effectiveness, technology for treating severe diseases, improved implement capacity, and innovative technology (without substitutes). The findings of DCE will improve the current evaluation on the value of implantable medical devices in China and provide decision-makers with the relative importance of the criteria in pricing and reimbursement decision-making of implantable medical devices.

Validation of a real-time biliopancreatic endoscopic ultrasonography analytical device in China: a prospective, single-centre, randomised, controlled trial

Endoscopic ultrasonography (EUS) is a key procedure for the diagnosis of biliopancreatic diseases. However, the performance among EUS endoscopists varies greatly and leads to blind spots during the operation, which can impair the health outcomes of patients. We previously developed an artificial intelligence (AI) device that accurately identified EUS standard stations and significantly reduced the difficulty of ultrasonography image interpretation. In this study, we updated the device (named EUS-IREAD) and validated its performance in improving the quality of EUS procedures. In this single-centre, randomised, controlled trial, we updated EUS-IREAD so it consisted of five learning models to identify eight EUS stations and 24 anatomical structures. The trial was done at the Renmin Hospital of Wuhan University (Wuhan, China) and included patients aged 18 years or older with suspected biliopancreatic (pancreas and biliopancreatic duct) lesions due to clinical symptoms, radiological findings, or laboratory findings, and with a high risk of pancreatic cancer. Patients were randomly assigned (1:1) by a dedicated research assistant using a computer-generated random number series (with a block size of four) to undergo the EUS procedure with or without the assistance of EUS-IREAD. Endoscopists in the EUS-IREAD-assisted group were required to observe all standard stations and anatomical structures according to the prompts by the AI device. Data collectors, the independent data anaylsis team, and patients were masked to group allocation. The primary outcome was the missed scanning rate of standard stations between the two groups, which was assessed in patients who underwent EUS procedure in accordance with the assigned intervention (per protocol). This trial is registered with ClinicalTrials.gov, NCT05457101. Between July 9, 2022, and Feb 28, 2023, 290 patients (mean age 55·93 years [SD 14·06], 152 [52%] male, and 138 [48%] female) were randomly assigned and analysed, including 144 in the EUS-IREAD-assisted group and 146 in the control group. The EUS-IREAD-assisted group had a lower missed scanning rate of stations than the control group (4·5% [SD 0·8] vs 14·3% [1·0], -9·8% [95% CI -12·2 to -7·5]; odds ratio 3·6 [95% Cl 2·6 to 4·9]; p<0·0001). No significant adverse event was found during the study. Our study confirms the capability of EUS-IREAD to monitor the blind spots and reduce the missed rate of stations and structures during EUS procedures. The EUS-IREAD has the potential to play an essential part in EUS quality control. Innovation Team Project of Health Commission of Hubei Province and College-enterprise Deepening Reform Project of Wuhan University.

Survey-based investigation into the current use of paediatric medicines and administration devices in China

The accurate, rapid and convenient administration of medicines to children is not possible without the use of appropriate administration devices. However, due to the unique nature of this patient population, inappropriate paediatric medication administration has been widely observed worldwide. According to previous surveys carried out in other countries including the UK and Japan, there has been a wide variation in the handling of paediatric devices among children. To date, little is known about the current situation in China where the variety of available paediatric administration devices is more limited than in Europe and the UK. The aim of this study was therefore to conduct a China-wide survey to gain a better understanding of the perspectives of children and their caregivers on paediatric medicines and devices. This study was conducted throughout China with 215 children as well as 749 caregivers of paediatric year groups from 1 to less than 18 years old. The majority of participants (83%) took oral dosage forms where granules, syrup and tablets were ranked as the Top 3 commonly used oral dosage forms. The most commonly used devices, i.e., measuring cups (47.3%) and household spoons (41.1%) were both well accepted by the vast majority of children. More instruction and demonstration by the healthcare professionals were provided to inhalation devices users with the nebuliser and facemask being the most commonly used. In particular, the role of pharmacists in China is expected to be better defined, which may in turn help with the education provided to paediatric users in operating medical devices. The data collected varied considerably with the age of children but not statistically significantly with the region in which the survey was conducted.

Internet speech denoising method based on IGAN algorithm

At present, to settle the question of excessive noise in the speech signal during the call of mobile devices in China, the research proposes that the Wiener filter and the generative adversarial network are combined into the IGAN algorithm. Firstly, the Wiener filter regularization algorithm is introduced to construct the preprocessing model of the speech signal; then the preprocessing model is fused with the generative adversarial network algorithm to construct the denoising model. Finally, the performance analysis and simulation experiments of the application effect of the model are carried out. The results show that in the experiment comparing IGAN with five traditional algorithms, when the SNR ratio is increased to 17.5 dB, the MOS and PESQ scores under the IGAN method can reach 4.9 and 3.5 respectively, and the DNN effect is second only to IGAN. Other algorithms perform poorly. Then compare the number of iterations and the loss value between the two. When the network voice signal begins to converge, the loss value corresponding to DNN is 1.132; while the loss value of IGAN is about 0.573, it can be found that the loss value of IGAN has dropped by half, which shows that IGAN Build the model with a smaller loss value. And IGAN tends to converge when iteratively is performed for about 200 times, and the average peak SNR can reach up to 33.85 dB, an increase of nearly 1.02 dB, and the effect is remarkable. This all shows that the IGAN algorithm has the best denoising performance for network speech signals, improves the denoising efficiency, and is conducive to obtaining a denoising signal with a higher fit with the clean signal, so that mobile devices can better serve the people.

Analysis and prospects of the development of optoelectronic devices in China from the perspective of National Science Foundation of China

Analysis and prospects of the development of optoelectronic devices in China from the perspective of National Science Foundation of China

The Chinese version of the Computer Vision Syndrome Questionnaire: translation and cross-cultural adaptation

BackgroundThe Spanish version of the Computer Vision Syndrome Questionnaire (CVS-Q©) is a validated instrument, with good psychometric properties, to measure Computer Vision Syndrome (CVS) in workers using Video Display Terminals (VDTs). To date, there are no known valid instruments in Chinese for the assessment of CVS despite the high exposure to VDTs at work that this population presents. For this, the purpose of this study is to translate and cross-culturally adapt the CVS-Q© into Chinese.MethodsA study with five consecutive stages: direct translation, synthesis of translations, back translation, consolidation by a committee of experts, and pre-test. During the pre-test, a cross-sectional pilot study was conducted on VDT users (n = 44) who completed the Chinese version of the questionnaire plus an ad hoc post-test to assess the comprehensibility of the scale and to verify aspects of its applicability and feasibility. Data concerning sociodemographic information, general and ocular health, use of optical correction and varying exposure to VDTs was also collected.ResultsThe entire sample considered the Chinese version of the CVS-Q© simple, clear, and easy to understand and 95.5% also found it easy to complete. 88.7% considered that the scale did not need any improvement. The final version of the Chinese scale to measure CVS was obtained (the CVS-Q CN©). The mean age of participants was 31.3 ± 9.8 years, 47.6% were women, and 57.1% used VDTs to work for more than 8 h/day.ConclusionsThe CVS-Q CN© can be considered an easy tool to assess CVS in workers exposed to digital devices in China. This version would facilitate research, its use in clinical practice, and the prevention of occupational hazards in the workplace.

Full spectrum flow cytometry in the clinical laboratory.

Contemporary full spectrum or "spectral" flow cytometry is a recently developed technology that allows for high-dimensional flow cytometric analyses of cells and particles in suspension. This single-cell technology has gained popularity in research settings because it can conservatively detect 35 or more antigens simultaneously in a single-tube assay format. Recently, spectral flow cytometry has obtained regulatory approval for use as an in vitro diagnostic device in China and Europe, enabling use of this technology in some clinical flow cytometry laboratories. The purpose of this review is to describe the basic principles of conventional and spectral flow cytometry, contrasting these two technologies. To illustrate the analytic power of spectral flow cytometry, we provide an example of spectral flow cytometry data analyses and the use of a machine learning algorithm to harvest the vast amount of information contained within large spectral flow cytometry datasets. Finally, we discuss the advantages of spectral flow cytometry adoption in clinical laboratories and preliminary studies comparing the performance of this technology relative to conventional flow cytometers that are currently used in clinical laboratory environments.

A COMPARATIVE STUDY OF MEDICAL DEVICES AND THEIR REGULATIONS IN US, EU, INDIA, AND CHINA

The usage of medical device is on the rise due to the rise in incidence rate of chronic diseases, irregular health check-ups, and sedentary lifestyles and also rising cases of obesity, diabetes, neuro-based disorders, heart diseases, and chronic diseases relating to lifestyle disorders. Availability of hassle free home monitoring medical devices that can be used even by patients with no knowledge about the technical aspects made their way into patient homes. Even in the presence of restraining factors such as high cost and reimbursement issues, the opportunities for medical device professionals lie in the technological advancements and usage of internet of medical things in modern healthcare and the latest trend toward developing smart medical devices with fast development in (AI) and (ML). The usage of medical devices is on the rise due to medical device development is undergoing a huge technological advancement due to emergence 3D printing which allows development of devices designed specifically as per patient requirements. Medical devices like freestyle liber system by Abbott laboratories eliminate need for routine finger pricking as it has sensor that measures and records glucose levels through clothing of the consumer. Quickie Q300 M mini Wheelchair fits even in tight doorways, navigates restaurants, that are crowded and also in difficult living spaces. Harmonization of medical devices registration across the markets is essential to paue way for their easy approval and also in dealing with the withdrawn issues related to quality, safety, and performance. This review involves a comparative study of medical device regulations in four regions (US, EU, India and China).

The Influence of Virtual Goods Purchase on Teenagers' Online Consumption——Genshin Impact Marketing Strategy as a Case

Mihoyo's open world mobile game Genshin Impact, launched in September 2020, set the record for the highest grossing mobile game worldwide for the month with $245 million, and was the highest grossing mobile game in China for six consecutive months. Behind this impressive performance, there have also been negative voices about inducing overspending in games. For a game aimed at teenagers, it sets very high purchase prices for virtual goods and lotteries and lacks guidance and efforts to protect teenagers. Teenagers are one of the biggest consumers of online games. With the rapid development and popularity of mobile Internet and smart devices in China, it is more convenient for Chinese teenagers to access online games, and the era of touch games shows a younger trend. This paper uses two practical cases to focus on the impact of the highly developed mobile game consumer market on consumers and enterprises. It analyzes and discusses from two perspectives, involving the analysis of marketing concepts, schemes, consumer psychology and other elements. In the end, it deduces the social and moral issues that enterprises need to pay attention to in their own operations and improves a cleaner consumer market together with consumer groups.

Analysis of Radio Frequency Identification Immunity Standard for Medical Equipment

Aiming at the increasing application of RFID technology in the medical environment, this study introduces the foreign requirements for RFID immunity test of medical devices, compares them with the current immunity test requirements of medical devices in China, and puts forward the necessity of establishing relevant test specifications in China.

Analysis of the Status of Radiation-generating Medical Devices in Mainland China.

The purpose of this paper is to describe the status of radiation-generating medical devices in mainland China. The number of diagnostic radiology and interventional radiology devices was collected from the national medical radiation protection monitoring information system, while the number of radiation therapy and nuclear medicine devices was from the published articles. Statistical analysis of the correlation was used to assess the relationship between the number of high technology medical devices and GDP per capita. A total of 143,064 radiation-generating medical devices were identified in mainland China, and diagnostic radiology devices accounted for 94% of those. The number of CTs was 14.84 per million, an increase by a factor of 1.45 compared to 2009. But the distribution of CTs was imbalanced among different areas: the highest number of CT per million population was 27.70 in Tibet, and the lowest was 8.55 per million population in Guangxi province. Statistical analysis of the correlation showed that the number of PET scanners per million population was positively correlated with GDP per capita, and similarly for medical accelerators. The number of mammographic devices per million population was much lower than that in other countries. The investment of radiation-generating medical devices in China was far from enough, especially for mammographic devices. More efforts should be taken to bring medical resources to regions with greater population areas in the future.Health Phys. 124(0):000-000; 2023.

Analysis of Bilibili's Competitive Strategy in the New Trends

According to the "2022-2027 China Internet Video Industry Market Depth Research and Investment Strategy Forecast Report" published by the China Research Institute of Industry, as of the end of June 2021, the size of China's Internet users broke one billion, reaching 1.011 billion people, an increase of 0.22 billion people compared to the end of December 2020, the massive size of Internet users to promote the development of China's online video industry. The size of the short video market will increase more quickly between 2020 and 2022, with a compound annual growth rate of about 44%. The market size will grow at a slower rate during 2023-2025, but will still maintain a CAGR of 16%. China's short video market is expected to reach nearly 600 billion yuan in 2025 [1]. More than a quarter of a day is spent watching short videos on mobile devices in China. Along with visuals and audio, short video has emerged as the "third language" of the mobile Internet. Short-form video has rapidly increased in the new Internet economy. Bilibili's future development has attracted much attention. With the development of the Internet economy and the increase in significant video websites, whether Bilibili can continue its competitive advantage and successfully achieve business transformation has become controversial. This research will analyse Bilibili's business model through a SWOT analysis and make feasible suggestions for its future development.

Market entry system considering the biosafety of nanomedical devices in China.

Our current knowledge on nanomaterials is mostly built on data from basic studies, and the application and developmental potentials of nanomaterials are emphasized. On the other hand, standard evaluation methods, models, exposure methods, standards, and guidelines for biological effect evaluation are inadequate. In response to the bottlenecks of supervision, scientific research institutes and regulatory organizations in China have cooperated closely to research and establish an evaluation system for nanomedical devices, and silver-containing nanomaterials have been adopted as an example. In such a context, reference materials, characterization strategies, in vitro and in vivo distribution and toxicity evaluation standards have been established. This article highlights research on the risk assessment of nanomedical device products (taking silver-containing nanomedical device products as an example) in China, including the characterization and release determination strategies, determination of nanosilver in tissues, applications of three-dimensional skin models and in vitro and toxicity evaluation standards have been established. This article highlights research on technical standards. As a consequence, the "Guidelines for the safety and effectiveness evaluation of nanomedical devices" were published in 2021, and a market entry framework for nanomedical devices has been preliminarily formed as a significant component in scientific supervision. This Guideline supervises the review and supervision of nanomedical devices and, therefore, provides a guarantee for the market access of nanomedical devices in China. This article is categorized under: Toxicology and Regulatory Issues in Nanomedicine > Toxicology of Nanomaterials Toxicology and Regulatory Issues in Nanomedicine > Regulatory and Policy Issues in Nanomedicine.

Analysis of Drug Clinical Trials for Eye Diseases in China.

Purpose: We systematically retrospected and analyzed the general characteristics of ophthalmic drug clinical trials (CTs) registered in China from January 2014 to December 2021. Methods: Data were retrieved from the Drug Trial Registration and Information Publication Platform and then standardized and statistically classified using bibliometric analysis. Results: We identified 201 drug CTs for eye diseases, including 24 international multicenter trials. The number of drug CTs for eye diseases has considerably increased since 2017 in parallel with new policies to encourage innovation in drugs and medical devices in China. The drug types consist of biologicals (48.26%), chemicals (45.77%), and traditional Chinese medicine/natural medicines (5.97%). The main indications were age-related macular degeneration (AMD; n = 47, 23.38%), macular edema (n = 32, 15.92%), and diabetic retinopathy (n = 19, 9.45%). The trials included those in phase I (n = 67, 33.33%), phase II (n = 33, 16.42%), and phase III (n = 72, 35.82%). The phase I trials comprised 24 innovative drug treatments for AMD and 6 novel drug treatments for neuromyelitis optica spectrum disorders, with 39 biologicals and 27 chemicals. The trials mostly followed a randomized (84.08%) or masked (67.16%) design, with 90.37% of the latter being double-masked trials. Conclusion: Research and development of ophthalmic drugs have substantially increased in recent years and are influenced by regulatory policies. Among these drugs, biologicals for AMD are the most prevalent, followed by biologicals for macular edema. Randomized double-masked research designs are often used and represent high-quality evidence.