Expert review of medical devices最新文献_第9页

The E-nside, multi-inner branch-based off-the-shelf stent graft for the treatment of thoracoabdominal aortic aneurysms. e- inside多内支支架用于胸腹主动脉瘤的治疗。

Expert review of medical devices Pub Date : 2025-03-01 Epub Date: 2025-02-24 DOI: 10.1080/17434440.2025.2465686

Paolo Calo, Miroslav Yordanov, Schäfers Johannes Frederik, Alexander Oberhuber

{"title":"The E-nside, multi-inner branch-based off-the-shelf stent graft for the treatment of thoracoabdominal aortic aneurysms.","authors":"Paolo Calo, Miroslav Yordanov, Schäfers Johannes Frederik, Alexander Oberhuber","doi":"10.1080/17434440.2025.2465686","DOIUrl":"10.1080/17434440.2025.2465686","url":null,"abstract":"Introduction: Endovascular repair for thoracoabdominal aortic aneurysms (TAAAs) has changed treatment paradigm over the past decades. However for urgent cases, there are not many options available. The E-nside (Artivion, Georgia, U.S.A.) endograft is one of the three off-the-shelf-aortic endografts available on the market. Its unique design with four inner branches and other special features offer more versatility, so more patients could be minimally invasively treated.Areas covered: We present a descriptive review based on market analysis on the available devices and a PubMed literature research on the E-nside endograft. The aim of this article is to present its unique structure, deployment method, and cannulation methods and discuss its applicability, indications, associated concerns and an overview of the available alternative devices.Expert opinion: The implantation of the E-nside endograft is a promising technique for treating not only TAAAs but also complex abdominal aortic aneurysm. Unlike FEVAR or BEVAR, which require precise planning and have the disadvantage of long manufacturing time. We think that with the off-the-shelf feature from E-nside endograft this can be obviated, and through its flexible planning along with its simple use, more patients could benefit and so favorable results can be achieve.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"177-185"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143426843","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Hematocrit and drug interference study of the new Arkray Glucocard S Onyx blood glucose meter meeting ISO 15197:2013 accuracy criteria - a contribution to patient safety. 符合ISO 15197:2013精度标准的新型arkray glucocard S onyx血糖仪的红细胞压积和药物干扰研究-对患者安全的贡献

Expert review of medical devices Pub Date : 2025-03-01 Epub Date: 2025-03-07 DOI: 10.1080/17434440.2025.2470295

Claudio Burrini, Beatrice Morrocchi, Nicola Giorgetti, Beate Saeger

{"title":"Hematocrit and drug interference study of the new Arkray Glucocard S Onyx blood glucose meter meeting ISO 15197:2013 accuracy criteria - a contribution to patient safety.","authors":"Claudio Burrini, Beatrice Morrocchi, Nicola Giorgetti, Beate Saeger","doi":"10.1080/17434440.2025.2470295","DOIUrl":"10.1080/17434440.2025.2470295","url":null,"abstract":"Introduction: Abnormal HCT levels and medications can cause inaccurate readings with blood glucose meters (BGM) in routine practice. The GLUCOCARD S onyx (ARKRAY Inc.) BGM was evaluated over a wide HCT range (20-70%) and its interaction with 27 common drug interferences, as per ISO15197:2013/EN ISO15197:2015, compared to clinical laboratory reference methods.Methods: Pooled venous blood samples from >200 participants were prepared with four HCT concentrations (20-70%) and three glucose concentrations (60-360 mg/dL). These were spiked with 27 potential interfering substances and tested using GLUCOCARD S onyx, Atellica CH (D-Glucose), and Sysmex XN-10 (HCT).Results: Stable performance meeting ISO15197:2013 criteria were observed at HCT concentrations of 20-25%, 42±2%, 55±2%, and 66-69% (Levene, one-way ANOVA, p>0.05). No significant differences in averages were found for most substances, except for Ascorbic acid (>6 mg/dL), Sodium (>180 mmol/L), and Xylose (>600 mg/dL). Ascorbic acid at 3 mg/dL and Sodium at 90 mmol/L showed no interference for normal to low glucose readings. .Conclusion: The GLUCOCARD S onyx BGM provided accurate glucose readings across a wide HCT range (20-70%) and under various medication conditions, enabling reliable diabetes management by patients and effective treatment by healthcare providers in complex clinical scenarios.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"253-260"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143545343","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Vigilance and medical devices: from theory to the field, the example of electroporation in atrial fibrillation. 警惕性与医疗器械：从理论到实际，心房颤动电穿孔的例子。

Expert review of medical devices Pub Date : 2025-03-01 Epub Date: 2025-02-11 DOI: 10.1080/17434440.2025.2463340

Cordélia Salomez-Ihl, Marvin Jacquet, Laura Quarteroni, Pascal Defaye, Delphine Schmitt, Philippe Py, Pierrick Bedouch

引用次数: 0

Investigation of the effectiveness of interactive telerehabilitation and transcutaneous electrical nerve stimulation on pain, functionality, disability and quality of life in patients with nonspecific chronic neck pain: a randomised controlled trial. 交互式远程康复和经皮神经电刺激对非特异性慢性颈痛患者疼痛、功能、残疾和生活质量的疗效研究：一项随机对照试验。

Expert review of medical devices Pub Date : 2025-03-01 Epub Date: 2025-02-26 DOI: 10.1080/17434440.2025.2471444

Musa Çankaya, Pariya PourİYamanesh, Sami Küçükşen

{"title":"Investigation of the effectiveness of interactive telerehabilitation and transcutaneous electrical nerve stimulation on pain, functionality, disability and quality of life in patients with nonspecific chronic neck pain: a randomised controlled trial.","authors":"Musa Çankaya, Pariya PourİYamanesh, Sami Küçükşen","doi":"10.1080/17434440.2025.2471444","DOIUrl":"10.1080/17434440.2025.2471444","url":null,"abstract":"Objectives: Despite the widespread use of TENS in the treatment of chronic nonspecific neck pain (CNNP), there are few studies on Telerehabilitation (TR), and no studies comparing their effectiveness compared to each other in this field. It was planned to investigate and compare the effectiveness of TENS and TR, which is an online rehabilitation tool.Methods: Forty-eight (female 45, male 3) patients with CNNP, aged 36.31 + 12.54 years, were randomized into TENS, TR or control groups. Pain severity was determined by Visual Analog Scale (VAS), Bournemouth Neck Questionnaire (NBQ), Neck Disability Index (NDI), Copenhagen Neck Functional Disability Scale (CNFDS), and World Health Organization Quality of Life Module (WHOQOL-BREF).Results: VAS, NBQ, NBI, CNFDS Time*Group interaction showed a significant positive change after treatment (p = 0.013, p = 0.007, p = 0.022, p = 0.005, respectively). The effect size of this difference over time was large (pη2 = 0.177, pη2 = 0.198, pη2 = 0.156, pη2 = 0.208, respectively). Post-treatment, the highest mean difference was found in VAS and NDI values in the TENS (MD:2.656, MD:7.000, p < 0.001), NBQ, CNFDS, WHOQOL-Bref in the TR (MD:13.187, MD:5.312, MD:-9.660, p < 0.001, respectively).Conclusion: VAS and NBQ in the TENS and NDI, CNFS, WHOQOL-Bref in the TR group were more effective after treatment than before treatment in patients with CNNP.Trial registration: The clinical trial registration number for this study was: NCT06206343 (ClinicalTrials.gov).","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"243-252"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143485190","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The use of predetermined change control plans to enable the release of new versions of software as a medical device. 使用预先确定的变更控制计划，以便作为医疗设备发布新版本的软件。

Expert review of medical devices Pub Date : 2025-03-01 Epub Date: 2025-02-28 DOI: 10.1080/17434440.2025.2468787

Jacques Andre DuPreez, Olivia McDermott

{"title":"The use of predetermined change control plans to enable the release of new versions of software as a medical device.","authors":"Jacques Andre DuPreez, Olivia McDermott","doi":"10.1080/17434440.2025.2468787","DOIUrl":"10.1080/17434440.2025.2468787","url":null,"abstract":"Objectives: This study investigates how Predetermined Change Control Plans (PCCPs) can support the Software Development Life Cycle (SDLC) of certain Software as a Medical Device (SaMD).Methods: Targeted surveys collected qualitative and quantitative data on the current regulatory change process for SaMD; the use of PCCPs; the potential parameters of PCCPs in terms of technical, clinical, usability, and administrative changes to SaMD; and whether PCCPs could be used more broadly for all SaMDs.Results: Results indicate that the current regulatory approach is not fit for purpose, specifically regarding fast-moving SaMD or continuous-learning AI SaMD. There was strong support for PCCPs to cover device technology, usability, and administrative changes, while clinical changes had limited support and required further investigation. The EU lags behind the US and now the UK in addressing these challenges and should look to legislate and implement PCCPs to ensure ongoing innovation and investment in digital health technologies.Conclusion: This work is novel in the gathering of meaningful input from experts, practitioners, and regulatory professionals within the SaMD industry located in the EU, UK, and US on the value and need for PCCPs. This study has implications for practice and policy as it can inform SaMD guidance and legislation.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"261-275"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143442967","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Smart clothing for human movement analysis: future application in sport and clinical practice. 用于人体运动分析的智能服装：未来在运动和临床实践中的应用。

Expert review of medical devices Pub Date : 2025-01-01 Epub Date: 2025-01-21 DOI: 10.1080/17434440.2025.2454933

Rachel Mason, Gill Barry, Rodrigo Vitorio, Oisin Lennon, Hugh Robinson, Ben O'Callaghan, Rosie Morris, Alan Godfrey, Samuel Stuart

引用次数: 0

Wearable technology in inflammatory bowel disease: current state and future direction. 炎症性肠病的可穿戴技术：现状和未来方向。

Expert review of medical devices Pub Date : 2025-01-01 Epub Date: 2025-01-15 DOI: 10.1080/17434440.2025.2453561

Sidharth Harindranath, Devendra Desai

{"title":"Wearable technology in inflammatory bowel disease: current state and future direction.","authors":"Sidharth Harindranath, Devendra Desai","doi":"10.1080/17434440.2025.2453561","DOIUrl":"10.1080/17434440.2025.2453561","url":null,"abstract":"Introduction: Wearables are electronic devices worn on the body to collect health data. These devices, like smartwatches and patches, use sensors to gather information on various health parameters. This review highlights the current use and the potential benefit of wearable technology in patients with inflammatory bowel disease (IBD).Areas covered: In this review, we explore the current use of wearable technology in healthcare and the studies applying this technology in patients with IBD. We also discuss the limitations of using digital health data in general and wearable technology in particular in the current clinical paradigm and predict a path forward in how to rationally and effectively apply this technology to improve the care of patients with IBD. A comprehensive search of all suitable studies was conducted using the databases of PubMed, MEDLINE, Embase, and Scopus from inception to August 2024.Expert opinion: Currently, wearable technology is applied to the monitoring of IBD and prediction of flares using devices and sensors. Future applications include early disease detection using biosensors, advanced data collection through ingestible devices, gut microbiome monitoring, and integration with machine learning. These advancements promise to revolutionize disease management, including IBD, by enabling early diagnosis, personalized treatment, and improved patient outcomes.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"121-126"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142967629","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Techniques in hybrid repair of aortic arch and thoracoabdominal aortic pathologies. 主动脉弓与胸腹主动脉病变混合修复技术。

Expert review of medical devices Pub Date : 2025-01-01 Epub Date: 2025-01-06 DOI: 10.1080/17434440.2024.2442483

Meena M Archie, Mark M Archie, Ali Khoynezhand

引用次数: 0

A retrospective study of reported adverse events associated with cardiac stents in Indian population. 对印度人群中与心脏支架相关的不良事件的回顾性研究。

Expert review of medical devices Pub Date : 2025-01-01 Epub Date: 2025-01-22 DOI: 10.1080/17434440.2025.2456526

Sandeep Mewada, Shatrunajay Shukla, Maneesh Soni, Meenakshi Dahiya, Vivekanandan Kalaiselvan, Pooja Reddy, Avinash Singh Mandloi, Vipin Dhote

{"title":"A retrospective study of reported adverse events associated with cardiac stents in Indian population.","authors":"Sandeep Mewada, Shatrunajay Shukla, Maneesh Soni, Meenakshi Dahiya, Vivekanandan Kalaiselvan, Pooja Reddy, Avinash Singh Mandloi, Vipin Dhote","doi":"10.1080/17434440.2025.2456526","DOIUrl":"10.1080/17434440.2025.2456526","url":null,"abstract":"Background: Cardiac stents are utilized to treat coronary artery diseases, a leading cause of death worldwide including in India. We investigated frequency and nature of adverse events (AEs) associated with cardiac stents in the Indian population.Methods: The source data was systematically collected by National Coordination Centre-Materiovigilance programme of India (NCC-MvPI), anonymized from 2020 to 2022. The database contained 10,542 reports of medical devices adverse events, with cardiac stents accounting for 2,075 of these events. These reports were meticulously collected, cleaned, segregated, and analyzed.Results: We observed that 93% AEs associated with cardiac stents were serious, with the most common being dissection followed by chest pain, thrombosis, and breathing difficulties. However, only 5% of reports resulted in death. Additionally, male patients experienced more AEs than female and elderly patients had a higher incidence of AEs after stent placement.Conclusion: The study highlights the need for continued research in this area to identify the root cause of AEs associated with cardiac stents and develop effective measures to reduce these incidences. Future studies can also focus on evaluating the long-term outcomes of patients with cardiac stents to gauge safety and effectiveness of different stent types.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"149-153"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143018831","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Amblyopia screening: the current state and opportunities for optimization. 弱视筛查：当前状态及优化机会。

Expert review of medical devices Pub Date : 2025-01-01 Epub Date: 2025-01-06 DOI: 10.1080/17434440.2024.2449490

Jonathan Morse, Julius T Oatts

{"title":"Amblyopia screening: the current state and opportunities for optimization.","authors":"Jonathan Morse, Julius T Oatts","doi":"10.1080/17434440.2024.2449490","DOIUrl":"10.1080/17434440.2024.2449490","url":null,"abstract":"Introduction: Amblyopia, the leading cause of monocular childhood vision loss, affects millions and is projected to increase. Early detection and treatment are crucial for preventing vision impairment.Areas covered: This commentary reviews the current state and opportunities for improvement in amblyopia screening strategy and technology focused primarily within the United States. A review of current guidelines from organizations and a literature review of innovations between 1999 and 2024 informed this commentary. Organizations recommend routine vision screening for children, starting in infancy and continuing through adolescence. However, the variations in screening devices, components, timelines, and requirements leave room for improving outcomes. An exploration of instrument-based screening which has emerged as an alternative to traditional optotype testing will be investigated, and the risks of these instruments with high sensitivity and varying specificity will be acknowledged. Finally, new approaches to directly identify amblyopia and search for innovative biomarkers that indicate amblyopia risk or amblyopia itself will be discussed.Expert opinion: Improving the treatment of amblyopia necessitates the reimagination of current practices in connecting patients to care. Technologies that incorporate novel diagnostic approaches, like the consideration of specific biomarkers or the use of artificial intelligence, hold promise to identify cases of amblyopia rather than its risk factors.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-4"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11750595/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142934167","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0