Nanomaterials (NMs) are having a huge impact in several domains, including the fabrication of medical devices (MDs). Hence, nanostructured MDs are becoming quite common; nevertheless, the associated risks must be carefully considered in order to demonstrate safety prior to their immission on the market. The biological effect of NMs requires the consideration of methodological issues since already established methods for, e.g., cytotoxicity can be subject to a loss of accuracy in the presence of certain NMs. The need for oversight of MDs containing NMs is reflected by the European Regulation 2017/745 on MDs, which states that MDs incorporating or consisting of NMs are in class III, at highest risk, unless the NM is encapsulated or bound in such a manner that the potential for its internal exposure is low or negligible (Rule 19). This study addresses the role of NMs in medical devices, highlighting the current applications and considering the regulatory requirements of such products.

Over the past decade, the use of telehealth has garnered increasing attention. The focus on quality aspects has seen significant growth in tandem with the telehealth expansion. Having useful indicators in this area is becoming increasingly strategic for fully integrating the technology into the health domain. These indicators can help monitor and evaluate the quality of telehealth services, guiding improvements and ensuring that these digital solutions meet the necessary standards for effective healthcare delivery. The purpose of this study is to analyze Key performance indicators (KPIs) in telehealth within institutional websites and the scientific dissemination world by means of a narrative review. A narrative review was proposed with these two specific points of view based on a standardized checklist and a quality control procedure for including scientific papers in the analysis. Results from scientific studies emphasize KPIs such as patient outcomes, operational efficiency, technical reliability, and cost-effectiveness. These include measures like improvements in condition management, patient satisfaction, consultation numbers, waiting times, and cost savings. Institutional documents from entities like the WHO also show diverse perspectives, focusing on equitable access, clinical excellence, patient prioritization, response times, and patient and staff satisfaction. The findings suggest that adopting a comprehensive set of KPIs and continuously monitoring and evaluating telehealth services can enhance their effectiveness, efficiency, and equity, ultimately improving healthcare outcomes and accessibility.

In the last two decades, a growing interest has been focused on gait and balance robot-assisted rehabilitation in children with neurological disabilities. Robotic devices allow the implementation of intensive, task-specific training fostering functional recovery and neuroplasticity phenomena. However, limited attention has been paid to the protocols used in this research framework. This systematic review aims to provide an overview of the existing literature on robotic systems for the rehabilitation of gait and balance in children with neurological disabilities and their rehabilitation applications. The literature search was carried out independently and synchronously by three authors on the following databases: MEDLINE, Cochrane Library, PeDro, Institute of Electrical and Electronics Engineers, ScienceDirect, and Google Scholar. The data collected included three subsections referring to clinical, technical, and regulatory aspects. Thirty-one articles out of 81 found on the primary literature search were included in the systematic review. Most studies involved children with cerebral palsy. Only one-third of the studies were randomized controlled trials. Overall, 17 devices (nine end-effector systems and eight exoskeletons) were investigated, among which only 4 (24%) were bore the CE mark. Studies differ on rehabilitation protocols duration, intensity, and outcome measures. Future research should improve both rehabilitation protocols’ and devices’ descriptions.

The expanding role of technology assessment in telemedicine is the focus of this study. An umbrella review has been proposed to delve into emerging themes within telemedicine technology assessment by scrutinizing systematic reviews gathered from PubMed and Scopus. The proposed approach was based on a standard narrative checklist and a qualification process. The selection process identified 20 systematic reviews. The main findings underscore the transformative potential of telemedicine, emphasizing technology assessments focused on systematic evaluations, stakeholder engagement, societal impact recognition, targeted interventions, and structured frameworks. While offering valuable insights, the current studies highlight certain limitations that require attention. There is a need for the following: (I) First of all, a more focused approach, primarily centered on a process-centric, multidomain, and generalizable technology assessment (TA). (II) A deeper analysis in specific healthcare areas, including a comprehensive examination of the cost–benefit ratio, peer-to-peer interactions, and a broader inclusion of diagnostic technologies. (III) Greater emphasis on the involved stakeholders, ranging from patients to stakeholders. In conclusion, this study contributes to a comprehensive and nuanced understanding of the continually evolving landscape in telemedicine technology assessment, offering valuable insights for practitioners, researchers, and policymakers alike. Researchers are encouraged to further explore both the established and emerging themes identified in this study.

The development of fetal cardiac surgery, considered the ultimate goal in the treatment of congenital cardiac malformations, needs to be supported by detailed knowledge of the blood circulation in the fetal cardiovascular system. The hemodynamic behavior in distal territories is usually inferred from vessel resistance indices, which give limited physiological information. This study presents a mathematical model of the human fetal global cardiovascular system, developed to clarify the relationships and differences existing between upper and lower body circulation. We modelled the heart with two time-varying capacitances, each representing the respective ventricle's pressure-volume relationship. The fetal vascular system was represented using two six-element Windkessel models, for the upper and lower body respectively. We obtained the identification of the set of circuital and elastance function parameters of the model using Genetic Algorithms (GAs), which follow the laws of evolutionary theory. We compared the results of our numerical study on the model identified with data collected from measurements and literature, to validate the proposed global cardiovascular system model of the human fetus. This model is intended as an instrument to investigate the differences in blood distribution between the different vascular districts in the upper and lower fetal body and the role of the aortic isthmus, the small tract of vessel connecting upper and lower fetal vascular beds; it may also represent a useful tool in the assessment of dynamic balance during mechanical assistance of circulation.

Background: The Telemechron project addresses critical needs in telemedicine by evaluating technology assessment frameworks and key performance indicators (KPIs), among other objectives. Effective frameworks and KPIs are crucial for assessing telemedicine services, especially in terms of their impact on patient outcomes and service efficiency. Methods: This study adopted a dual approach to assess the contributions of the Telemechron project. Firstly, it applied a technology assessment framework to quantitatively evaluate telemedicine services, focusing on measurable improvements and systematic analysis. Secondly, it investigated a set of predefined KPIs using specific metrics and parameters to evaluate their applicability and limitations in telemedicine settings. Results and Discussion: The technology assessment framework demonstrated significant utility by providing structured, quantifiable improvements across key aspects of telemedicine services. It was effective in evaluating the alignment of services with strategic goals and their integration with existing healthcare systems. The predefined KPIs, although not developed within this study and not directly used by the different operational units (OUs)—which established their own context-specific KPIs—still provided valuable insights into telemedicine performance. However, the study revealed that these KPIs highlighted a need for further customization to enhance their relevance across various contexts. While the KPIs may offer useful performance indicators, their general applicability necessitated adjustments to better address the specific needs of telemedicine applications. The analysis model for the KPI set, in terms of metrics and parameters, is exportable and generalizable to other national and international telemedicine contexts. Conclusions: The study confirms the effectiveness of the framework in delivering measurable improvements in telemedicine services and underscores the importance of adapting KPIs for specific contexts. Future research should focus on further applying and expanding the framework and metrics, refining KPI models, integrating new technologies, and conducting cross-national comparisons to enhance the applicability and effectiveness of telemedicine evaluations.