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Software problem resolution and change control processes are crucial for the performance, safety, and regulatory clearance of a medical device. Software changes are frequent throughout the whole life cycle of a product; therefore, iterative analysis and risk assessment are necessary to determine the impact of changes on the whole system. IEC standard 62304 clarifies software medical device life cycle processes including problem and modification analysis and requirements. The aim of this work is to describe a cost‐effective and fully customizable solution for software medical devices problem and modification management implemented in our group. Key features of the problem and modification management related to the software life cycle have been identified and taken into account. A digital commercial platform for software development and maintenance has been identified and used to implement an architecture satisfying the standard. The architecture solution (SWMA, software maintenance architecture) has been successfully developed and a description of how it addresses IEC 62304 standard requirements both in terms of problem resolution and in terms of change control has been provided. The presented system can be useful for manufacturers/groups to establish software maintenance plans that include activities and tasks related to software problem resolution and change control processes. The approach can be adopted for analyzing and resolving problems arising before and after the release of a medical device. [ABSTRACT FROM AUTHOR]

Background: Regulation is part of the technology innovation process and has a key role within the lifecycle of a medical device aiming at ensuring effectiveness and safety for users (1). Ever-increasing regulatory requirements (e.g., the Regulation MDR (EU) 2017/745) impact on the development of novel and already approved systems (2, 3). Debating and raising awareness is important since it can improve the transfer of knowledge and expertise among the relevant stakeholders. Thus, the implementation of a survey to explore knowledge and perception of the regulatory framework of medical devices for the assessment of vascular age can be helpful for the involved community. Methods: A multidisciplinary team including clinicians, researchers and developers from VascAgeNet was established to design and implement a digital questionnaire. A secure, open-source, two-factor authentication system for generation, distribution, and data collection of the survey supported by the European Commission (EUSurvey, https://ec. europa. eu/eusur vey) was adopted. Results: The questionnaire has received ethical clearance by National Council of Research, Italy (Notification 0063984/2021) and University College London (17999/002) Research Ethics Committees and is being distributed digitally (e.g., within VascAgeNet, Artery Society etc.). The anonymous questionnaire is available at https://ec. europa. eu/eusur vey/runner/REGUL ATORY Surve y2022 or by scanning the QR code below, it takes approximately 10 min to complete. Conclusions: A survey related to regulation and medical devices for vascular ageing assessment has been developed and is available for the community. The results could inspire concrete actions reducing gap between research and clinical practice. [ABSTRACT FROM AUTHOR]

Background: The intense exercise effect evaluation on the cardiovascular system can help to profile and reduce the risks (1-3). This work aims at assessing cardiovascular adaptation in runners by a multi-site non-invasive approach. Methods: 49 runners (A) trained for 8.5 ± 8.9 years, 3.9 ± 1.4 days/week and 15 sedentary (S) subjects matched by sex, age, BMI, baseline brachial pressures and heart rate underwent ultrasound semi-automatic assessment of the vascular system (arterial mean diameters, MD, and distensibility, DC, of abdominal aorta, common carotid, common femoral, brachial artery) and of cardiac parameters. Central pressurebased (applanation tonometry) hemodynamic properties according to the reservoir theory were derived. Results: Cardiac parameters related to dimensions, mass and volumes showed significantly higher values in A compared to S (A/S: Left Ventricular Internal diameter, 29 ± 3 mm/27 ± 3 mm; Left Ventricular Mass, 161 ± 31 g/141 ± 25 g; Aortic root size 30 ± 3 mm/27 ± 2 mm; Stroke Volume, 76 ± 13 mL/69 ± 16 mL; Arterial Elastance, 7 ± 1 mm HgmL-1/6 ± 1 mm HgmL-1). MD was greater in each large arterial site in A than in S reporting a trend in the carotid and significant differences in aorta and femoral artery (aorta: 16 ± 2 mm/13 ± 1 mm; femoral: 10 ± 1 mm/9 ± 1 mm). DC evidenced a lowering trend in A for each arterial site except for the brachial artery. Hemodynamic parameters showed higher reservoir pressure in A compared to S (Pressure reservoir integral, 14 ± 4/11 ± 3). Conclusions: Strenuous exercise induced a well-known cardiac remodeling which can be hypothesized to be slower in the arterial tree because of highly differentiated and complex mechanism aiming to heart protection. Accordingly, the increased reservoir pressure in runners could be interpreted as sentinel parameter of vascular "fatigue". [ABSTRACT FROM AUTHOR]

Due to its central role in immunosuppression and cellproliferationand due to its specific peptidyl-prolyl-isomerase (PPI) function,the FKBP protein family is at the crossroad of several important metabolicpathways. Members of this family, and notably FK506 binding protein(FKBP12), are thought to be involved in neurodegenerative diseasessuch as Alzheimer disease, Parkinson disease, multiple sclerosis,amyotrophic lateral sclerosis, as well as in proliferation disordersand cancer. Using an interdisciplinary approach based on computational,synthetic, and experimental techniques, we show that the best potentialbinders for FKBP proteins optimally expose the two contiguous carbonyloxygen in the proline-mimetic chain for FKBP docking and are characterizedby the abundance of rigid quasi-cyclic structuresstabilized in aqueous solution by intraligand hydrophobic interactionsmimicking the macrolide structure of the natural FKBP binders FK506and Rapamycin. These peculiar structural and chemical-physical featuresdefine at the same time an ElteX compound and the minimal pharmacorein the FKBP family, shedding new light on the isomerization mechanismof the PPI domain. On the basis of the above hypothesis, we have successfullydesigned and synthesized several nanomolar ElteX FKBP12 ligands. Amongthese, ElteN378 is a new low atomic weight ligand with affinity comparableto that of the macrolide Rapamycin. [ABSTRACT FROM AUTHOR]

Present environmental issues force the research to explore radically new concepts in sustainable and renewable energy production. In the present work, a functional fluid consisting of a stable colloidal suspension of maghemite magnetic nanoparticles in water was characterized from the points of view of thermoelectrical and optical properties, to evaluate its potential for direct electricity generation from thermoelectric effect enabled by the absorption of sunlight. These nanoparticles were found to be an excellent solar radiation absorber and simultaneously a thermoelectric power-output enhancer with only a very small volume fraction when the fluid was heated from the top. These findings demonstrate the investigated nanofluid's high promise as a heat transfer fluid for co-generating heat and power in brand new hybrid flat-plate solar thermal collectors where top-heating geometry is imposed. [ABSTRACT FROM AUTHOR]