Search Results (16)

Humanity stands at a pivotal moment of technological revolution, with artificial intelligence (AI) reshaping fields traditionally reliant on human cognitive abilities. This transition, driven by advancements in artificial neural networks, has transformed data processing and evaluation, creating opportunities for addressing complex and time-consuming tasks with AI solutions. Convolutional networks (CNNs) and the adoption of GPU technology have already revolutionized image recognition by enhancing computational efficiency and accuracy. In radiology, AI applications are particularly valuable for tasks involving pattern detection and classification; for example, AI tools have enhanced diagnostic accuracy and efficiency in detecting abnormalities across imaging modalities through automated feature extraction. Our analysis reveals that neuroimaging and chest imaging, as well as CT and MRI modalities, are the primary focus areas for AI products, reflecting their high clinical demand and complexity. AI tools are also used to target high-prevalence diseases, such as lung cancer, stroke, and breast cancer, underscoring AI’s alignment with impactful diagnostic needs. The regulatory landscape is a critical factor in AI product development, with the majority of products certified under the Medical Device Directive (MDD) and Medical Device Regulation (MDR) in Class IIa or Class I categories, indicating compliance with moderate-risk standards. A rapid increase in AI product development from 2017 to 2020, peaking in 2020 and followed by recent stabilization and saturation, was identified. In this work, the authors review the advancements in AI-based imaging applications, underscoring AI’s transformative potential for enhanced diagnostic support and focusing on the critical role of CNNs, regulatory challenges, and potential threats to human labor in the field of diagnostic imaging. Full article

Background: In vivo visualization of malignant tumors remains the main challenge during head and neck cancer surgery. This can result in inadequate tumor margin assessment and incomplete tumor resection, adversely affecting patient outcomes. Hyperspectral imaging (HSI) is a promising approach to address this issue. However, its application in surgery has been limited by the lack of medically approved HSI devices compliant with MDR regulations, as well as challenges regarding the integration into the surgical workflow. Methods: In this feasibility study, we employed endoscopic HSI during surgery to visualize the tumor sites of 12 head and neck cancer patients. We optimized the HSI workflow to minimize time required during surgery and to reduce the adaptation period needed for surgeons to adjust to the new workflow. Additionally, we implemented data processing to enable real-time classification and visualization of HSI within the intraoperative setting. HSI evaluation was conducted using principal component analysis and k-means clustering, with this clustering validated through comparison with expert annotations. Results: Our complete HSI workflow requires two to three minutes, with each HSI measurement—including evaluation and visualization—taking less than 10 s, achieving an accuracy of 79%, sensitivity of 72%, and specificity of 84%. Medical personnel became proficient with the HSI system after two surgeries. Conclusions: This study presents an HSI workflow for in vivo tissue differentiation during head and neck cancer surgery, providing accurate and visually accessible results within minimal time. This approach enhances the in vivo evaluation of tumor margins, leading to more clear margins and, consequently, improved patient outcomes. Full article

This work reports on an in vivo Raman-based endoscopy system, invaScope, enabling Raman measurements of healthy and tumor bladder tissue during an endoscopic procedure in the operating theatre. The presented study outlines the progression from the initial concept (validated through previously performed ex vivo studies) to the approval and implementation of a clinical investigational device according to the requirement within the framework of the European Medical Device Regulation (MDR2017/745). The study’s primary objective was to employ the invaScope Raman system within the bladder, capturing in vivo spectroscopic Raman data followed by standard histo- and cytopathological examinations of urological tissue (considered the gold standard). The collected data were analyzed and correlated with histopathological findings post-procedure. Additionally, the study aimed to assess the feasibility of using diagnostic equipment, probes, and software for application in a clinical setting, evaluating usability aspects that are important during surgical procedures. This research represents a pivotal step toward advancing Raman spectroscopy for routine clinical use in characterizing bladder lesions. Full article

The Medical Device Regulation (MDR) in Europe aims to improve patient safety by increasing requirements, particularly for the clinical evaluation of medical devices. Before the clinical evaluation is initiated, a first literature review of existing clinical knowledge is necessary to decide how to proceed. However, small and medium-sized enterprises (SMEs) lacking the required expertise and funds may disappear from the market. Automating searches for the first literature review is both possible and necessary to accelerate the process and reduce the required resources. As a contribution to the prevention of the disappearance of SMEs and respective medical devices, we developed and tested two automated search methods with two SMEs, leveraging Medical Subject Headings (MeSH) terms and Bidirectional Encoder Representations from Transformers (BERT). Both methods were tailored to the SMEs and evaluated through a newly developed workflow that incorporated feedback resource-efficiently. Via a second evaluation with the established CLEF 2018 eHealth TAR dataset, the more general suitability of the search methods for retrieving relevant data was tested. In the real-world use case setting, the BERT-based method performed better with an average precision of 73.3%, while in the CLEF 2018 eHealth TAR evaluation, the MeSH-based search method performed better with a recall of 86.4%. Results indicate the potential of automated searches to provide device-specific relevant data from multiple databases while screening fewer documents than in manual literature searches. Full article

The human hand is the most precise and versatile tool that nature has given man, and any deficits in this area affect the functional capabilities and quality of human life. Scientists, engineers and clinicians are constantly looking for solutions in the field of diagnosis, treatment, rehabilitation and care of patients with hand function deficits. One such solution is a hand exoskeleton. In the process of designing and testing the hand exoskeleton, emphasis should be placed on the full usability and comfort of the system; hence, the issues of personalization, matching and testing are crucial for the development of the discussed group of solutions. The aim of this paper is to present the possibilities of personalizing 3D-printed medical devicesbased on our own experience in functional user assessment andthe material selection, design, optimization using artificial intelligence and production and testing of several generations of different upper limb exoskeletons, incorporatingthe considerations of the Medical Device Regulation (MDR), ISO 13485 and ISO 10993 standards.The novelty and possible contribution of the proposed approach consist of the possibilities and limitations of the personalization of the upper limb exoskeleton discussed in the article as well as the directions of further development of significant scientific, technical and clinical importance. Full article

Cytocompatibility analyses of new implant materials or biomaterials are not only prescribed by the Medical Device Regulation (MDR), as defined in the DIN ISO Norm 10993-5 and -12, but are also increasingly replacing animal testing. In this context, jellyfish collagen has already been established as an alternative to mammalian collagen in different cell culture conditions, but a lack of knowledge exists about its applicability for cytocompatibility analyses of biomaterials. Thus, the present study was conducted to compare well plates coated with collagen type 0 derived from Rhizostoma pulmo with plates coated with bovine and porcine collagen. The coated well plates were analysed in vitro for their cytocompatibility, according to EN ISO 10993-5/−12, using both L929 fibroblasts and MC3T3 pre-osteoblasts. Thereby, the coated well plates were compared, using established materials as positive controls and a cytotoxic material, RM-A, as a negative control. L929 cells exhibited a significantly higher viability (#### p < 0.0001), proliferation (## p < 0.01), and a lower cytotoxicity (## p < 0.01 and # p < 0.05)) in the Jellagen® group compared to the bovine and porcine collagen groups. MC3T3 cells showed similar viability and acceptable proliferation and cytotoxicity in all collagen groups. The results of the present study revealed that the coating of well plates with collagen Type 0 derived from R. pulmo leads to comparable results to the case of well plates coated with mammalian collagens. Therefore, it is fully suitable for the in vitro analyses of the cytocompatibility of biomaterials or medical devices. Full article

Three-dimensional-printed medical devices are a separate group of medical devices necessary for the development of personalized medicine. The present article discusses a modern and specific group of medical devices and exoskeletons, which aims to present our own experiences in the selection of materials, design, artificial-intelligence optimization, production, and testing of several generations of various upper limb exoskeletons when considering the Medical Devices Regulation (MDR) and the ISO 13485 and ISO 10993 standards. Work is underway to maintain the methodological rigor inherent in medical devices and to develop new business models to achieve cost-effectiveness so that inadequate legislation does not stop the development of this group of technologies (3D scanning, 3D printing, and reverse engineering) in the healthcare system. The gap between research and engineering practice and clinical 3D printing should be bridged as quickly and as carefully as possible. This measure will ensure the transfer of proven solutions into clinical practice. The growing maturity of 3D printing technology will increasingly impact everyday clinical practice, so it is necessary to prepare medical specialists and strategic and organizational changes to realize the correct implementation based on the needs of patients and clinicians. Full article

Candida auris is a multi-drug-resistant fungal pathogen that can survive outside the host and can easily spread and colonize the healthcare environment, medical devices, and human skin. C. auris causes serious life-threatening infections (up to 60% mortality) in immunosuppressed patients staying in such contaminated healthcare facilities. Some isolates of C. auris are resistant to virtually all clinically available antifungal drugs. Therefore, alternative therapeutic approaches are urgently needed. Using in silico protein modeling and analysis, we identified a highly immunogenic and surface-exposed epitope that is conserved between C. albicans hyphal-regulated protein (Cal-Hyr1p) and Hyr1p/Iff-like proteins in C. auris (Cau-HILp). We generated monoclonal antibodies (MAb) against this Cal-Hyr1p epitope, which recognized several clinical isolates of C. auris representing all four clades. An anti-Hyr1p MAb prevented biofilm formation and enhanced opsonophagocytic killing of C. auris by macrophages. When tested for in vivo efficacy, anti-Hyr1p MAb protected 55% of mice against lethal systemic C. auris infection and showed significantly less fungal burden. Our study is highly clinically relevant and provides an effective alternative therapeutic option to treat infections due to MDR C. auris. Full article

The vast scope of 3D printing has ignited the production of tailored medical device (MD) development and catalyzed a paradigm shift in the health-care industry, particularly following the COVID pandemic. This review aims to provide an update on the current progress and emerging opportunities for additive manufacturing following the introduction of the new medical device regulation (MDR) within the EU. The advent of early-phase implementation of the Quality by Design (QbD) quality management framework in MD development is a focal point. The application of a regulatory supported QbD concept will ensure successful MD development, as well as pointing out the current challenges of 3D bioprinting. Utilizing a QbD scientific and risk-management approach ensures the acceleration of MD development in a more targeted way by building in all stakeholders’ expectations, namely those of the patients, the biomedical industry, and regulatory bodies. Full article

In Germany, the medical device industry constitutes a cornerstone of the health sector. In this study, we investigated the challenges and factors affecting the present-day performance of German SMEs concerned with medical devices. The research methodology adopted a cross-sectional and correlational research design, with simple random-sampling techniques, to data obtained from 110 mid-level and senior managers in German SMEs by means of an online structured survey in August 2022. We statistically validated our study data using exploratory factor analysis (EFA), Kaiser–Meyer–Olkin (KMO) testing, and Bartlett’s test, to assess the relationship between study variables and measure data adequacy using the R4.1.1(21) software, then carried out principal component analysis (PCA) with varimax factor loading and extracted six factors for use as research variables. The researchers also applied descriptive data analysis techniques using SPSS.21. The main study variables were: (1) the business performance of small and medium businesses (SMP); (2) their financial situation (SMEF); and (3) their implementation of new medical device industry regulations (MDR). By such statistical means, results confirmed poorer business performance and lower anticipated growth amongst SMEs affected by MDR, over and above the impacts of the present-day economic situation. The data can be used by management information systems (MIS) and decision system support professionals for planning and developing practical models about how to cope with current industry challenges. We recommend further research involving inferential analysis and triangulation of these data in the form of a semi-structured qualitative study in the larger scope of the population and different sectors. Full article

The recently adopted Medical Device Regulation (MDR) has finally entered into force on 26 May 2021. As innovation and especially the advent of customized prostheses has deeply modified many surgical procedures in our discipline, it is imperative for the contemporary surgeon to become aware of the impact that the MDR will have on many aspects, including the choice of the manufacturer, the evaluation of the devices, point-of-care 3D printing labs, and medical software. In this paper, the authors tried to identify the cultural gaps in clinical practice that the MDR is supposed to fill. To achieve this purpose, a task force of experts was reunited, including CMF surgeons with direct expertise in medical software and 3D printing, mechanical and material engineers, facing the topic of the MDR from a multidimensional perspective. In this article, surgeons and engineers review many crucial aspects concerning the points of the regulation that mostly affect the field of implantable devices for the cranio-maxillo-facial skeleton. The result of interdisciplinary research is a paper aiming to provide surgeons with the knowledge on the fundamental processes of additive manufacturing, increasing the clinician’s awareness on the evaluation of a customized implant before surgery and on the underlying regulatory framework. Full article

Within the healthcare environment, mobile health (mHealth) applications (apps) are becoming more and more important. The number of new mHealth apps has risen steadily in the last years. Especially the COVID-19 pandemic has led to an enormous amount of app releases. In most countries, mHealth applications have to be compliant with several regulatory aspects to be declared a “medical app”. However, the latest applicable medical device regulation (MDR) does not provide more details on the requirements for mHealth applications. When developing a medical app, it is essential that all contributors in an interdisciplinary team—especially software engineers—are aware of the specific regulatory requirements beforehand. The development process, however, should not be stalled due to integration of the MDR. Therefore, a developing framework that includes these aspects is required to facilitate a reliable and quick development process. The paper at hand introduces the creation of such a framework on the basis of the Corona Health and Corona Check apps. The relevant regulatory guidelines are listed and summarized as a guidance for medical app developments during the pandemic and beyond. In particular, the important stages and challenges faced that emerged during the entire development process are highlighted. Full article

New medical technologies can transform healthcare, and automation of processes is becoming increasingly ubiquitous within the patient care sector. Many innovative ideas arise from academia, but regulations need to be taken into account if they want to reach the market and create a real impact. This is particularly relevant for applied fields, such as prosthetics, which continuously generates cutting-edge solutions. However, it remains unclear how well the regulatory pathway is supported within universities. This study applied a data-driven assessment of available online information regarding support of medical device regulations within universities. A total of 109,200 URLs were screened for regulatory information associated with universities in the UK and the USA. The results show that based on available online data, 55% of the selected universities in the UK and 35% in the USA did not provide any support for medical device regulations. There is a big discrepancy between universities in terms of the available support, as well as the kind of information that is made accessible by the academic institutes. It is suggested that increasing support for regulatory strategies during the early phases of research and development will likely yield a better translation of technologies into clinical care. Universities can play a more active role in this. Full article

During the 20th century, metal alloys have assumed an important role as restorative materials. Among existing examples, cobalt–chromium (Co–Cr) alloys increasingly began to be used in medicine and especially in dentistry. Their success is mainly due to their mechanical properties such as stiffness, strength and corrosion resistance, thus allowing a high biocompatibility. There are quite meaningful data on the corrosion and toxicity of Co–Cr alloys for their use in restorative materials such as dental prostheses. Toxicological studies following Co and Cr exposures in the oral cavity are more difficult to conduct because there are many different situations leading to the release of metal ions and wear particles. Furthermore, the links between exposure and the appearance of local or systemic toxicity are not automatic. Since 2017, the European Union (EU) regulatory framework for Co–Cr alloys has been undergoing profound changes. A new EU Medical Devices Regulation (MDR) (2017/745) will be applied in May 2021 with the need to consider that Co metal is a new carcinogenic, mutagenic and toxic to reproduction (CMR) substance. On 18 February 2020, the 14th Adaptation to Technical Progress (ATP14) to the Classification, Labelling and Packaging (CLP) regulation was published, including the harmonised classification for Co metal as a CMR 1B substance. In this context, the use of Co might be forbidden if the medical devices are invasive and as soon as they include more than 0.1% (m/m) Co. This review provides a specific overview on Co–Cr dental alloys in terms of metal ions and wear particles release, toxicological risks, and the actual and new EU regulatory framework. Full article

In the Czech Republic, the medical device industry is an important sector with a strong tradition and has high added value and perspectives in demand under changing demographic and social structures. The aim of this article is to describe and analyze the complex issues of the new European Commission Medical Device Regulation (MDR) 2017/745 from the perspective of the strategic decisions of companies that have to comply with the requirements imposed on them by the new legislation and at the same time fulfill their own business needs and goals. The legislative changes significantly affect the standards, processes, and certifications in the medical device sector. The classification system of medical devices has been revised to more appropriately reflect the possible health risks associated with use of modern high-end technology in healthcare. The requirement is to categorize each device under the highest possible risk class, which means for the medical device manufacturers to carefully review the new rules and regulations and classify their devices accordingly. Full article