Device Market Research Articles

High-performance cellulose aerogel membrane for lithium-ion battery separator.

Lithium-ion batteries (LIBs) are the mainstream of the energy storage device market. Efficient and environmentally friendly separators are beneficial for LIBs. Here, we prepared a regenerated cellulose (RC) aerogel with three-dimensional (3D) pores, which was used as the separators of LIBs. Under the effects of homogeneous pore structure and excellent specific surface area, LIBs that use 3 wt% RC aerogel membrane as a separator showed the initial specific capacity of 101.3 mAh g-1 at 1C, 74.3 % capacity retention rate after 110 cycles, which were higher than that of the commercial Celgard 2340 separator-based battery. In addition, the stability and wettability of the RC aerogel membranes as separators were also studied. These results indicated that the RC aerogel membranes can be used as efficient and environmentally friendly cellulose-based separators for LIBs.

Exploring the Relationship Between Capital Structure and SME Profitability: A Case Study of Lusaka's Electronic Device Market

The capital structure decisions made by Small and Medium Enterprises (SMEs) within the electronic device market in Lusaka, Zambia, significantly impact their financial health and long-term sustainability. This study aims to understand how the allocation of financing through debt and equity affects SME profitability, filling a gap in empirical evidence specific to Zambia's electronic device market. Capital structure decisions play a pivotal role in determining firms' financing policies and overall performance. Through a descriptive research design and panel data analysis, this study investigates the relationship between capital structure and profitability. Findings reveal that while factors such as financial risk, market conditions, and access to financing options may influence SME profitability, the effects are not statistically significant. However, better access to financing options and favorable market conditions are associated with higher growth prospects. Recommendations include exploring additional factors affecting SME growth, adopting a comprehensive approach to financing, conducting market analysis, enhancing financial risk management, capacity building, and government support. Policymakers and SMEs can utilize these insights to optimize capital structure decisions, foster growth, and contribute to economic development in Zambia's electronic device market. Further research, including longitudinal studies, is recommended to deepen understanding and inform strategic decision-making in this dynamic sector.

Market Review for Implantable Medical Devices

Background. The article provides the data on the global market volume for implantable medical devices and analyzes the domestic market needs of various branches of medicine. Examples of international and Russian developments of implantable medical devices are given. Promising directions for growing the Russian market are specified.Material and methods. The authors analyzed the information sources considering the state of the implantable medical device market over the last 10 years.Conclusion. Implantable medical devices have been used in practical healthcare for several decades. To date, implantable devices, including new applications, have assisted with treating a wide range of diseases: sleep apnea, panic attacks, Parkinson's disease, epilepsy, urinary incontinence, gastrointestinal diseases, autoimmune diseases, mental disorders, etc.

Market development trend and marketing strategy analysis of rehabilitation medical devices based on biomechanical principles

Based on the principle of biomechanics, this study analyzes in-depth the development trend and marketing strategy of the rehabilitation medical device market. It is found that the market is characterized by expanding scale, product diversification and intensifying competition, driven by policy support, market demand and technological innovation, but still facing constraints such as market competition, insufficient investment in research and development and shortage of talents. Marketing strategies such as product innovation, reasonable pricing, channel expansion and brand promotion are proposed, and the effectiveness of the strategies is verified with case studies. In order to promote the healthy development of the industry, it is suggested to increase policy support, upgrade the industrial chain, cultivate professional talents and strengthen international cooperation.

Market Review for Implantable Medical Devices

Background. The article provides the data on the global market volume for implantable medical devices and analyzes the domestic market needs of various branches of medicine. Examples of international and Russian developments of implantable medical devices are given. Promising directions for growing the Russian market are specified.Material and methods. The authors analyzed the information sources considering the state of the implantable medical device market over the last 10 years.Conclusion. Implantable medical devices have been used in practical healthcare for several decades. To date, implantable devices, including new applications, have assisted with treating a wide range of diseases: sleep apnea, panic attacks, Parkinson's disease, epilepsy, urinary incontinence, gastrointestinal diseases, autoimmune diseases, mental disorders, etc.

Stabilizing Diketopyrrolopyrrole Radical Cations Through Carbazoles: Substitution Pattern vs Spin Delocalization.

The synthesis of organic radicals continues to garner significant interest due to their fascinating optical, electronic, and magnetic properties. Moreover, the growing demand for chemically stable organic radicals is driven by the rapid expansion of the market for electronic devices utilizing organic semiconductors. In this context, the development of multifaceted approaches for the design of stable organic radicals is of great importance. In this work, we introduce a strategy for generating stable radical cations of diketopyrrolopyrroles (DPP) by modulating the substitution pattern of the electron-donating carbazole substituent. Using electronic, spin resonance, and vibrational spectroscopies, supported by density functional theory, we carefully investigated the electronic structures and chemical stability of the DPP radical cations. Our findings demonstrate that the position of electron-rich heteroatoms and the presence of Clar's aromatic sextets in donor moieties play a pivotal role in enhancing the chemical stability of DPP radical cations.

Formation of the market of software medical devices in the Russian Federation in 2007–2024: Practical results

According to the recommendations of The International Medical Device Regulators Forum (IMDRF), software intended for medical purposes falls under the category of medical devices (MD). In recent years, in Russia, a great deal of systematic work has been carried out to establish normative regulations and processes for controlling the efficiency and safety ofsoftware as medical devices (SaMD) and its subsequent state registration. Objective. The analysis of current procedures and results of state registration of SaMD in the Russian Federation in 2007–2024. Materials and methods. A systematic search of information on the software registered in Russia as MD was carried out. For this, the state registry of MD of the Federal Service for Surveillance in Healthcare of Russia (Roszdravnadzor) was used. 157 records of marketing authorizations (MA) issued between 01. 01. 2007 and 30. 07. 2024 were found. Results. 25.5 % of MAs were issued for radiological information systems, including image archiving and communication systems (PACS-systems). For SaMD with artificial intelligence technologies – 24.2 % MAs. 13.4 % of MAs were issued for laboratory information systems and 4.5 % for medical information systems of medical organizations. The “Other software” group accounted for 32.5 %, it included telemedicine solutions, software for planning surgeries, etc. More than 50 % of Mas for SaMD was issued for Russian-based developers. Half of SaMD was registered as the 2nd class of potential risk application (50 %), 17 % as the class 2b, and 18 % as the lowest 1st class of potential risk. 15 % of SaMD were of the maximum 3rd class of the potential risk of application, and most of them were SaMD with artificial intelligence (AI) technologies. Conclusion. In Russia, a system of independent testing and state registration of SaMD has been built and has been working reliably for many years, allowing manufacturers to bring to the market the most diverse products, including innovative AI-based MD. Russian development companies are gradually increasing their market share compared to foreign producers.

Clinical challenges and opportunities related to the biological responses experienced by indwelling and implantable bioelectronic medical devices.

Implantable electrodes have been utilized for decades to stimulate, sense, or monitor a broad range of biological processes, with examples ranging from glucose monitoring devices to cochlear implants. While the underlying science related to the application of electrodes is a mature field, preclinical and clinical studies have demonstrated that there are still significant challenges in vivo associated with a lack of control over tissue-material interfacial interactions, especially over longer time frames. Herein we discuss the current challenges and opportunities for implantable electrodes and the associated bioelectronic interfaces across the clinical landscape with a focus on emerging technologies and the obstacles of biofouling, microbial colonization, and the foreign body response. Overcoming these challenges is predicted to open the door for a new generation of implantable medical devices and significant associated clinical impact. STATEMENT OF SIGNIFICANCE: Implantable electrodes have been utilised for decades to stimulate, sense, or monitor a broad range of biological processes, with examples ranging from glucose monitoring devices to cochlear implants. Next-generation bioelectronic implantable medical devices promise an explosion of new applications that have until this point in time been impossible to achieve. However, there are several persistent biological challenges hindering the realisation of these new applications. We present a clinical perspective on how these biological challenges have shaped the device market and clinical trial landscape. Specifically, we present statistical breakdowns of current device applications and discuss biofouling, the foreign body response, and microbial colonisation as the main factors that need to be addressed before a new generation of devices can be explored.

Revealing the Fading Mechanism of Long-Term Cycling Performance of Graphite/Silicon Composite Anode for Lithium-Ion Batteries

Lithium-ion batteries (LIBs) have been employed across a diverse range of applications, spanning from small portable devices to large electric vehicles and stationary energy storage systems. With the growing market for electric devices, the demand for rechargeable batteries with higher energy densities than conventional LIBs has increased.Graphite (Gr), of which theoretical capacity is 372 mAh g-1, is utilized as anode material in current LIBs because of its cycle stability, low price, and high conductivity. Despite these advantages, the graphite anode has used its maximum utilization, which has reached its theoretical capacity. Therefore, silicon (Si), of which theoretical capacity is 3579 mAh g-1, has emerged to achieve more higher energy density than that of Gr. Silicon anode, however, undergoes extremely large volume expansion during alloying/dealloying process, leading to pulverization, loss of electrical contact, and excessive solid electrolyte interface (SEI) layer formation. Eventually, this large volume expansion reduces cell life. Despite intensive effort for Si-dominant electrodes, a real application of this strategy to battery industry is unsure. In this regard, gradual replacement of Gr to Si is adaptable in practical perspective. For the practical use of graphite/Si electrodes, the research on the long-term cycling performance of wide temperature range is highly important. However, most research has mainly focused on charge/discharge mechanisms in short cycles or conducted experiments with half cells, which do not represent the actual commercial battery systems. Therefore, research on the aging mechanism of composite anode under conditions similar to real operating environments is needed.To reveal the aging mechanism of composite anode, full cell configuration with high mass loading electrodes was used for the electrochemical performance test. Under wide temperature range, different cycling performance were observed. The cell reassembly experiment is conducted to figure out which electrodes is mainly contributed to the capacity loss of full cell during cycling. From this experiment, the anode degraded more rapidly. Through scanning electron microscopy (SEM) and transmission electron microscopy (TEM), we observed changes in the morphology of the electrodes with varying cycle numbers and temperatures. The composite anode is degraded during cycling, and notably, a peculiar structure of SEI was observed. Additionally, secondary-ion mass spectroscopy (SIMS), X-ray photoelectron spectroscopy (XPS) is conducted to analyze the SEI structure, which determines the cycle life of batteries. The deeper understanding of the mechanism of long-term cycling performance will provide as primary key for the commercialization of composite anode design.Figure 1. a Scheme of the capacity loss of anode and cathode harvested from full coin cell after long-term cycling performance. b Voltage profiles of lithium half cell with aged anode and pristine electrode. c Voltage profiles of lithium half cell with aged cathode and pristine electrode. Figure 1

Development of a High-Capacity MXene Electrode for All-Solid-State Batteries

The global market of energy storage devices is growing for the large-scale applications such as electric vehicles and stationary power supplies. Lithium-ion batteries (LIBs) now dominate the market owing to their large energy density and long cycle life. However, the flammable organic electrolytes of LIBs pose intrinsic risks of fire and explosion accidents. Replacing the organic electrolytes with nonflammable inorganic solid electrolytes should solve the safety issue of LIBs, which accelerates development of all-solid-state batteries (ASSBs).Conventional electrode materials show large volume changes upon (de)lithiation, causing interfacial failure between electrode materials and solid electrolytes in ASSBs.Consequently, lithium-ion flux is excessively concentrated on remaining solid-solid interfaces or loses accessibility to electrode materials. Although spinel-type Li4Ti5O12 shows a small volume change upon (de)lithiation, the specific capacity is not satisfactory (< 170 mAh g–1), which results in low energy densities. Therefore, electrode materials that show a small volume change with a large specific capacity is required to develop ASSBs with long cycle life and high energy density.Since the first report in 2011, layered transition-metal carbide/nitride (MXene) has been investigated as electrode materials for energy storage devices.1 MXene, which is represented with a general chemical formula M n +1X n T x (M = Ti, V, Nb, etc.; X = C and N; T = F, OH, O, etc.; n = 1–4), shows small volume change upon (de)lithiation with large specific capacities (~200 mAh g–1) at a low operation voltage (~1.0 V vs Li/Li+).2,3 The strain-free property of MXene is beneficial to improve the cycle life of all-solid-state batteries. In this presentation, we develop a high-capacity Ti2CT x MXene as an anode material for ASSBs. Li3PS4 glass is used as a solid electrolyte because its high ionic conductivity (~2×10–4 S cm–1) and high ductility.Ti2CT x was synthesized by removing Al layers from Ti2AlC using a LiF/HCl etchant. Li3PS4 glass electrolyte was synthesized by mechanochemical milling. The Ti2CT x |Li3PS4 glass electrode delivers a specific capacity of 340 mAh g–1 at a specific current of 20 mA g–1 in a voltage range from –0.6 to 2.4 V vs. InLi. After the 80th cycle, 74% of the first discharge capacity is retained (239 mAh g–1) with a coulombic efficiency of 99.4% (Fig. 1). Electrochemical impedance spectroscopy indicates that a stable solid-solid interface forms between Ti2CTx and Li3PS4 glass, which is beneficial for the long cycle life.Reference X. Wang, S. Kajiyama, H. Iinuma, E. Hosono, S. Oro, I. Moriguchi, M. Okubo, A. Yamada, Nat. Commun. 6, 6544 (2015).M. Okubo, A. Sugahara, S. Kajiyama, A. Atsuo, Acc. Chem. Rev. 51, 591–599 (2018).K. Kawai, M. Fujita, R. Iizuka, A. Yamada, M. Okubo, 2D Mater. 10, 014012 (2023). Figure 1

(Invited) Tracking Lithiation with Advanced Transmission Electron Microscopy

The primary advantages of Li ion batteries (LIBs) over traditional energy storage devices include high voltage, large capacity and stable cycling ability [1]. Despite their tremendous success in the market of portable devices and electric vehicles, people are developing next generation of batteries for large-scale energy storage or severe working environment, which demands LIBs with better cycling stability, safety and higher energy-density. Investigations on how Li ions transport through the components in a battery, such as anode, cathode, and electrolyte, would be helpful to understand the performances of LIBs, and therefore to realize reversible lithiation/delithiation during cycling.Transmission electron microscopy (TEM) is an indispensable tool in probing real-space local structures at atomic resolution. Recently, advanced TEM techniques have been applied into tracking the transportation of lithium ions in battery materials [2]. Emerging methods like ABF, e-ABF, iDPC, EELS and ptychography offer possibilities to atomically observe Li ions' occupations, identify their chemical environment, and track the dynamics of their insertion and extraction [3-6]. At present, cryo-TEM technique is a hot spot to study the solid-electrolyte interphase where Li contained organic or inorganic compounds are very beam sensitive [7]. In-situ TEM techniques have unparallel merits to track the migration of lithium ions or see the phase transmission of electrode materials [8-9]. In this talk, we introduce the techniques for direct observation of Li species and their research advances in LIB materials. Perspectives for the current challenges and future development to investigate Li-containing materials are discussed.

AESware: Developing AES-enabled low-power multicore processors leveraging open RISC-V cores with a shared lightweight AES accelerator

As open-source RISC-V cores continue to be released, the development of low-power multicore processors utilizing these cores is invigorating the edge/IoT device market. Nevertheless, comprehensive research on developing low-power multicore processors with integrated security features using existing open RISC-V cores remains limited. This study addresses this gap by introducing AESware, a dedicated lightweight hardware designed for energy-efficient AES (Advanced Encryption Standard) task execution, contributing to the development of AES-specific low-power RISC-V multicore processors. AESware supports variable key lengths and ensures minimal power consumption with a compact design. This standalone IP (Intellectual Property) is compatible with various open RISC-V cores, offering scalability and convenience. And importantly, we propose the most energy-efficient architecture for multicore processors equipped with AESware. Instead of assigning dedicated AESware to each core, we introduce a shared AESware architecture to maximize energy efficiency. We develop an operational algorithm for task scheduling in AESware, achieving maximum utilization and minimal latency while maintaining its lightweight nature. To evaluate our solution, we developed 24 processors into three groups: AESware-equipped, baseline, and those with an external AES accelerator per core. After FPGA (Field-Programmable Gate Array) prototyping for functional verification and power consumption analysis via 45 nm process technology synthesis, our findings revealed significant energy savings. AESware-equipped processors achieved up to 76%, 47%, and 33% energy savings at dual-, quad-, and octa-core configurations compared to baseline, respectively, and were more energy-efficient in running AES applications than those with individual accelerators.

Deployment of in-body wearable devices in healthcare and at work: closing the EU regulatory gap

Abstract Background In-body wearable devices can protect workers’ health and safety. Moreover, they might provide data that could be capitalized on in the context of the European Health Data Space (EHDS), which aims at fostering a single market for medical devices and high-risk AI systems. Yet, neither EU legislation nor national law regulates the use of in-body wearables at the workplace and the related data protection and safety issues. This regulatory gap impacts on workers’ rights. Methods The study explores whether the EU regulatory framework used in the healthcare sector for medical devices could fit the in-body wearables’ application in employment. The legal and policy analysis takes the perspective of workers’ rights and discusses the application of a key GDPR principle: lawfulness. The research discusses the potential transformations in the EU health data protection framework that could close the regulatory gap. Results The EU regulatory framework for medical devices (focused on product safety, performance, and quality) is not equipped to address the data protection challenges linked to the use of in-body wearables for occupational health and safety purposes. The GDPR’s principle of lawfulness and the related guidance by EU and national data protection authorities lack clarity on employers’ possibilities to apply in-body wearables for occupational health purposes. Filling the regulatory gap is conducive to appropriate qualification and risk-based classification of in-body wearables, which affect pre- and post-market requirements and impact on data protection. Conclusions a. The EU legislator could use its social policy competence to regulate the use of in-body wearables to protect workers’ health while safeguarding their data. b. EU authorities should clarify whether and how the data collected by in-body wearables at the workplace could be shared and (re)used within the EHDS. c. Further input by data protection authorities is needed to close the regulatory gap. Key messages • The EU should regulate the use of in-body wearables to protect workers’ health and safety. • Health data gathered through the application of in-body wearables at the workplace may be an asset for the EHDS.

Impact of in-silico technologies in the development of high-risk medical devices on healthcare

Abstract This study examines the impact of in-silico technologies (IST), such as virtual cohorts and digital twins, on the development of high-risk medical devices within the healthcare sector. An iterative empirical approach combining a literature review, exploratory and in-depth interviews with stakeholders from academia, industry, regulators, healthcare professionals, and focus groups with patients across Europe, Japan, and the USA was employed to gain insight into the implications of IST on healthcare. The findings indicate that IST can reduce the time to market for medical devices, thereby facilitating faster, broader, and more equitable access for patients. The implementation of extensive early testing, optimized study designs and increased sample sizes in trials can facilitate the achievement of enhanced safety. The early identification of adverse effects can enhance the safety of medical devices and improve patient outcomes. Furthermore, IST may facilitate the inclusion of underrepresented groups, such as children, in clinical trials, thereby enhancing their representation in medical research. The reduction in costs associated with IST may facilitate innovation cycles. However, the impact on prices is contingent on competition. Furthermore, IST have the potential to reduce the need for animal testing. Nevertheless, several uncertainties and potential adverse effects have been identified. Physician training on new devices remains a bottleneck, which may limit the benefits of new products. Despite the advancements, a complete replacement of traditional clinical and preclinical trials with IST is not seen to be feasible. From a policy perspective, it is crucial to promote regulatory clarity by providing guidance for the usage of IST, to offer incentives for the adoption of IST, and to foster competition. These findings demonstrate the multifaceted potential benefits and challenges of IST, including enhanced safety, accessibility, and innovation in healthcare. Key messages • In-silico technologies can reduce time-to market of medical devices up medical device and improve safety for patients. • Challenges like physician training and regulatory guidance must be addressed to fully realize benefits of in silico technologies.

Single-Use Technology in Purification of Monoclonal Antibiotics

The advent of Single-Use Technologies (SUT) has revolutionized biopharmaceutical manufacturing, offering a flexible and efficient alternative to traditional methods. This paper explores the diverse applications of SUT, focusing on therapeutic plasma filtration, clarifying processes, virus removal strategies, and chromatography solutions. Highlighting the advantages such as convenience, reduced contamination risk, and streamlined processes, the document delves into the economic and environmental impacts of adopting SUT. Despite challenges in scalability and automation, specific examples like Immusorba PH-350 and Pall Biotech's AllegroTM underscore the significant adsorption efficiency achieved with single-use systems. Anticoagulation strategies tailored for single-use plasma filtration contribute to optimal systemic performance. The dynamic market for disposable devices, featuring prominent manufacturers like Fresenius HemoCare, Kaneka, Medicap Clinic GmbH, Miltenyi Biotec, Toray Medical, and Biotex, reflects the widespread adoption of SUT across various medical applications. The ongoing innovation in overcoming scalability limitations and the commitment to standardization position SUT as a transformative force in modern biopharmaceutical manufacturing. In conclusion, the economic implications and positive environmental impact underscore SUT's potential to shape the future of the industry. Keywords: Single Use Technology, Reduced Contamination, Antibiotics, Biopharmaceutical, Good Manufacturing Practices, Mixing bag, Aseptic Connections, Single use Bioreactors, Disposable Chromatography Columns, Single use Filtration, Running Cost, Labour charges

Waterpipe size matters: the effect of waterpipe size on toxicant exposures and subjective experiences.

Waterpipe (WP) tobacco smoking remains popular among US young adults, yet specific regulations for WP devices are lacking. This study examines how WP device size (base volume and height) affects smoking behavior, toxicant exposures, and subjective experiences. Thirty-eight individuals who smoke WP aged 21 to 39 participated in a randomized crossover study. Each completed three 45-minute ad libitum smoking sessions using small, medium, and large WP sizes. Saliva nicotine and exhaled carbon monoxide (eCO) were measured before and after smoking. Puff topography was recorded during sessions, and subjective smoking experiences were collected afterward. Significant differences were observed in saliva nicotine between the three WP sizes, with higher concentrations for the small WP relative to larger sizes (Ps<0.05). Exhaled CO was significantly higher after smoking the large WP compared to smaller sizes (Ps<0.05). Puff topography revealed significant differences and followed a dose-response pattern, with larger size associated with longer puff duration, greater smoke volume inhaled, and larger puff volume (Ps<0.05). The large WP was associated with enhanced subjective experiences for satisfaction and concentration compared to the small WP (Ps<0.05). WP size substantially impacts smoking experiences and exposures. Regulation of WP size should be essential in comprehensive tobacco control policies aimed at curbing WP use among young adults. These findings will aid in developing of WP size-specific standards to regulate the marketing and sales of WP devices. Such regulations should aim to minimize toxicant exposure by controlling the dimensions and design of WP components, which can significantly influence smoking behavior and toxicant intake. This study underscores the critical role of waterpipe (WP) size in shaping smoking behavior, experiences, and exposures among young adults.

US FDA Advisory Panel Members’ Assessment of Premarket Approval Process and Suggestions for Improvement

The manufacturing and marketing of medical devices is regulated by the US Food and Drug Administration (FDA), and the FDA premarket approval (PMA) process evaluates the safety and effectiveness of medical devices. The PMA process includes a detailed scientific, regulatory and quality system review and is critical to ensure that novel devices are safe, effective, and meet the needs of patients. To survey current voting members serving on panels of the FDA's Medical Devices Advisory Committee to better characterize panel decision-making and identify steps for improvement. This qualitative survey study included 36 questions that were mailed to FDA device panelists regarding their opinions on the influence of sources of information, pivotal trial design, quality of evidence, panel composition and internal deliberative process, time allocation, and impartiality of the FDA. The survey was mailed to the members of all 18 FDA device panels in January and February 2017. Data were collected from January to May 2017 and analyzed from 2018 to 2019. Respondents read and returned the aforementioned paper survey, while nonrespondents did not. The main outcomes included panel members' perceptions, and their implications for process improvement. χ2 or Fisher exact tests were used to test differences between subgroups. Of 64 of 92 panel members who responded (69.6%), 38 of 64 (59.4%) were male, 3 of 63 (4.8%) were Black respondents, 46 of 63 (73.0%) were White respondents, and 36 of 60 (60.0%) were in academic practice. The mean (range) panel service was 6.8 (1-22) years with 3.9 (1-19) meetings attended. Overall, respondents considered information presented by the FDA unbiased, and 28 of 61 (45.9%) believed that pivotal trials were frequently well-designed, 55 of 62 respondents (88.7%) suggested FDA consult panel members preemptively regarding trial design and 54 of 64 (84.4%) regarding the device label. Most indicated that prior FDA approval of another device serving the same medical purpose (43 of 62 [69.4%]) or approval in other countries with comparable regulatory regimes, such as Canada and Europe (39 of 62 [62.9%]), would make them more likely to recommend approval. Respondents rated written information (50 of 60 [83.3%]), live presentations (43 of 58 [74.1%]), and prior professional knowledge (41 of 60 [68.3%]) as the most important sources of information in deciding whether to recommend approval. Additionally, 52 of 58 respondents (89.7%) recommended that a panel member-only executive session would allow more clarity and honesty in deliberations, and 33 of 59 (55.9%) believed a three-fourths majority appropriate for recommending approval, which would be a deviation from the current system in which an overall vote is reported without designation of a vote threshold. In this survey study of FDA device panel members, respondents wanted improved study designs, more relevant clinical data, including from other countries, involvement of panelists in study design and device label development, and inclusion of an executive session. Demographically, panels could be made more diverse.

CURRENT ISSUES OF IMPORT OF MEDICAL DEVICES AND EQUIPMENT TO THE RUSSIAN FEDERATION

The import of medical products remains an important topic at present, given the relevance of healthcare in connection with the sanctions policy of Western countries and the ambiguous situation with foreign supplies of medical products. The situation with the dominant share of imported medical products in the Russian market highlights the dependence on international supplies and technologies in the healthcare sector. The policies and sanctions imposed by the European Union and other countries regarding the supply of medical equipment to Russia cause certain restrictions and difficulties due to the current political situation. Although these goods are classified as vital and do not fall under sanctions, many companies from Europe and the United States have suspended deliveries due to the so-called «moral embargo». Lack of access to modern equipment and medicines can lead to a deterioration in the quality of medical care, an increase in waiting times for treatment, as well as possible complications and a deterioration in the prognosis of the disease in patients. The article analyzes the dynamics of the medical products market over the past few years, and identifies changes in the structure of the medical devices market. The share in the import of medical equipment to Russia was also studied. In addition, the prospects for the development of the medical industry are considered and the current situation is assessed. To solve the problem in the short term, the necessary measures have been proposed to include vital medical devices and equipment in the list of the Ministry of Industry and Trade for its import according to the rules of parallel import.

A deep learning approach for automated PCB defect detection: A comprehensive review

The ever-expanding market for electronic devices has significantly heightened the demand for high-quality printed circuit boards (PCBs). Even minor defects in PCBs can pose substantial safety risks for end-users. This article provides a comprehensive review on deep learning-based approaches for PCB defect detection. Our exploration covers various critical aspects, including the classification of PCB defects, automated vision inspection (AVI) techniques, object detection methodologies, and the widespread adoption of deep learning models. Specifically, we focus on the state-of-the-art approach known as region-based Fully Convolutional Network with Feature Pyramid Networks (FPN-RFCN). Additionally, we discuss effective data augmentation techniques and commonly used evaluation metrics in this domain. This review provides valuable insights for researchers, practitioners, and industry professionals engaged in PCB quality assurance.

Analysis the M&amp;A in Wearable Market: Evidence from Google purchase Fitbit

With the continuous progress of science and technology and the improvement of people's living standards, the wearable device market is gradually rising. These devices can be equipped with various sensors and have functions such as monitoring human health and statistical movement data, which have attracted the attention and favor of consumers. The content of this paper is a case analysis of Google's acquisition of Fitbit, which is mainly analyzed by comparing the financial data of the two companies before and after the acquisition. According to the evaluations, it is found that the acquisition is a success for both companies. For Google, operating income, net profit and total asset scale have increased significantly, which has a positive impact on the company, making the company's assets belong to an upward trend. For Fitbit, the acquisition has gradually reduced its loss and made its total assets more stable, with good development potential in the future.