Expert review of medical devices最新文献

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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
{"title":"Smart clothing for human movement analysis: future application in sport and clinical practice.","authors":"Rachel Mason, Gill Barry, Rodrigo Vitorio, Oisin Lennon, Hugh Robinson, Ben O'Callaghan, Rosie Morris, Alan Godfrey, Samuel Stuart","doi":"10.1080/17434440.2025.2454933","DOIUrl":"10.1080/17434440.2025.2454933","url":null,"abstract":"","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"111-116"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143018833","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
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":"<p><strong>Introduction: </strong>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).</p><p><strong>Areas covered: </strong>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.</p><p><strong>Expert opinion: </strong>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.</p>","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
{"title":"Techniques in hybrid repair of aortic arch and thoracoabdominal aortic pathologies.","authors":"Meena M Archie, Mark M Archie, Ali Khoynezhand","doi":"10.1080/17434440.2024.2442483","DOIUrl":"10.1080/17434440.2024.2442483","url":null,"abstract":"<p><strong>Introduction: </strong>Since the mid-1900s, techniques in the repair of aortic arch and thoracoabdominal aortic pathologies have drastically evolved. Open aortic surgical repair was once the sole option for both simple and complex aneurysmal degeneration. Today, a number of minimally invasive and hybrid approaches are now available to assist both the surgeon and patient in tackling this challenging problem.</p><p><strong>Areas covered: </strong>In this review, we discuss the most current techniques in the repair of these complex pathologies as well as new advances. These include aortic arch and abdominal aortic debranching with endovascular repair, branched stent graft repair, parallel grafting techniques, fenestration techniques, and a hybrid approach to the aforementioned. In addition, we discuss comparative outcomes of these techniques spanning disciplines of both cardiac and vascular surgery.</p><p><strong>Expert opinion: </strong>The most vital part of the treatment of complex aortic aneurysms is the tailoring of the treatment plan to each patient's unique anatomic and physiologic attributes.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":"22 1","pages":"23-30"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143018868","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
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":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","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":"<p><strong>Introduction: </strong>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.</p><p><strong>Areas covered: </strong>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.</p><p><strong>Expert opinion: </strong>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.</p>","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
Virtual reality therapy combined with physiological monitoring provides effective treatment, with objective metrics, for post-traumatic stress disorder. 虚拟现实治疗与生理监测相结合,为创伤后应激障碍提供了客观指标的有效治疗。
Expert review of medical devices Pub Date : 2025-01-01 Epub Date: 2025-01-22 DOI: 10.1080/17434440.2025.2454930
Brenda K Wiederhold, Mark D Wiederhold
{"title":"Virtual reality therapy combined with physiological monitoring provides effective treatment, with objective metrics, for post-traumatic stress disorder.","authors":"Brenda K Wiederhold, Mark D Wiederhold","doi":"10.1080/17434440.2025.2454930","DOIUrl":"10.1080/17434440.2025.2454930","url":null,"abstract":"","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"117-119"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143018865","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
A new horizon for aortic arch disease: the promise of total endovascular repair with triple-branched endografts. 主动脉弓疾病的新视野:三支血管内移植修复的前景。
Expert review of medical devices Pub Date : 2025-01-01 Epub Date: 2025-01-22 DOI: 10.1080/17434440.2025.2457483
Zelin Niu, Long Cao, Hongpeng Zhang
{"title":"A new horizon for aortic arch disease: the promise of total endovascular repair with triple-branched endografts.","authors":"Zelin Niu, Long Cao, Hongpeng Zhang","doi":"10.1080/17434440.2025.2457483","DOIUrl":"10.1080/17434440.2025.2457483","url":null,"abstract":"","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"107-109"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143018829","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
Effects of elevated body mass index on the success of total knee and total hip arthroplasty: a comprehensive overview. 体重指数升高对全膝关节和全髋关节置换术成功的影响:全面概述。
Expert review of medical devices Pub Date : 2025-01-01 Epub Date: 2024-12-23 DOI: 10.1080/17434440.2024.2444408
Benjamin E Jevnikar, Michael S Ramos, Ignacio Pasqualini, Shujaa T Khan, Nicolas S Piuzzi
{"title":"Effects of elevated body mass index on the success of total knee and total hip arthroplasty: a comprehensive overview.","authors":"Benjamin E Jevnikar, Michael S Ramos, Ignacio Pasqualini, Shujaa T Khan, Nicolas S Piuzzi","doi":"10.1080/17434440.2024.2444408","DOIUrl":"10.1080/17434440.2024.2444408","url":null,"abstract":"<p><strong>Introduction: </strong>The average body mass index (BMI) in the United States has tripled over the last five decades despite concerted population-based efforts for weight management. Elevated BMI and, in particular, obesity are risk factors for osteoarthritis. This trend has led to increased demands for total knee (TKA) and total hip arthroplasty (THA), necessitating an in-depth understanding of how elevated BMI impacts TKA and THA.</p><p><strong>Areas covered: </strong>This paper reviews the literature investigating the effects of elevated BMI, primarily obesity, on TKA and THA, focusing on preoperative, intraoperative, and postoperative considerations. It describes the associated risks, economic implications, and ethical considerations of patients with high BMIs undergoing TKA or THA. To ensure all relevant literature was included, Ovid Medline and Google Scholar databases were searched for the following terms, 'body mass index,' 'obesity,' 'knee,' 'hip,' and 'arthroplasty' for articles published from January 2019 through July 2024.</p><p><strong>Expert opinion: </strong>Despite the challenges of high BMI in TKA and THA, a deeper understanding of obesity as a chronic illness, coupled with advances in surgical techniques, can improve patient outcomes. A multidisciplinary approach and further research will optimize the care of patients with elevated BMIs undergoing total joint arthroplasty (TJA).</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"75-87"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142879086","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
Two-year outcomes using fast-acting sub-perception therapy for spinal cord stimulation: results of a real-world multicenter study in the United States. 使用速效亚知觉治疗脊髓刺激的两年结果:美国一项真实世界多中心研究的结果。
Expert review of medical devices Pub Date : 2025-01-01 Epub Date: 2025-01-16 DOI: 10.1080/17434440.2025.2453554
Clark Metzger, Blake Hammond, Richard Ferro, James North, Stephen Pyles, Andy Kranenburg, Edward Washabaugh, Edward Goldberg
{"title":"Two-year outcomes using fast-acting sub-perception therapy for spinal cord stimulation: results of a real-world multicenter study in the United States.","authors":"Clark Metzger, Blake Hammond, Richard Ferro, James North, Stephen Pyles, Andy Kranenburg, Edward Washabaugh, Edward Goldberg","doi":"10.1080/17434440.2025.2453554","DOIUrl":"10.1080/17434440.2025.2453554","url":null,"abstract":"<p><strong>Background: </strong>Fast-acting Sub-perception Therapy (FAST) is a novel spinal cord stimulation (SCS) modality delivering paresthesia-free pain relief. Our study evaluated the longer-term, real-world impact of FAST on chronic pain.</p><p><strong>Research design and methods: </strong>As part of a multicenter, real-world, consecutive case series, we retrospectively identified patients who used FAST-SCS and analyzed their data. The numerical rating scale (NRS) was used to evaluate the overall pain.</p><p><strong>Results: </strong>Data from 315 patients were analyzed at baseline and their last available follow-up (median 6.8 months after SCS implantation). At the time of the analysis, 12-, 18-, and 24-month data were available for 112, 86, and 50 patients, respectively. At the last follow-up, NRS pain score was reduced by 5.5 ± 2.5 compared to baseline (from 7.8 ± 1.7 to 2.3 ± 2.0; <i>p</i> < 0.0001). Interim long-term analysis showed that results were sustained for up to 2 years, with 64% of patients reporting a minimal overall pain score (NRS ≤2/10).</p><p><strong>Conclusion: </strong>This ongoing, real-world, multicenter study showed that FAST-SCS achieved significant paresthesia-free pain relief, while long-term interim analysis suggests that outcomes could be sustained for up to 2 years. Our data provide preliminary insights into the potential utility of this low-frequency sub-perception SCS paradigm using a biphasic active recharge pulse shape.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov (CT.gov identifier: NCT01550575).</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"155-164"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143018859","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
Device profile of the Mobi-C artificial cervical disc: an overview of its safety and efficacy. Mobi-C人工颈椎间盘的器械概况:安全性和有效性综述
Expert review of medical devices Pub Date : 2025-01-01 Epub Date: 2025-01-06 DOI: 10.1080/17434440.2024.2449504
Kee D Kim, Katherine A Curran, Richard L Price, Safdar Khan
{"title":"Device profile of the Mobi-C artificial cervical disc: an overview of its safety and efficacy.","authors":"Kee D Kim, Katherine A Curran, Richard L Price, Safdar Khan","doi":"10.1080/17434440.2024.2449504","DOIUrl":"10.1080/17434440.2024.2449504","url":null,"abstract":"<p><strong>Introduction: </strong>The Mobi-C Cervical Disc Replacement is a motion preserving alternative to anterior cervical discectomy and fusion in properly indicated patients. In 2013, Mobi-C became the first cervical disc in the United States approved to treat more than one level of the cervical spine. The FDA determined Mobi-C to be statistically superior to fusion at two levels, based on the primary endpoint of a prospective, concurrently controlled and randomized multicenter clinical trial.</p><p><strong>Areas covered: </strong>The history of Mobi-C and cervical disc arthroplasty is discussed. The unique biomechanics and structure of Mobi-C, the clinical results, the long term follow-up, the disc's biomechanics, and cost-effectiveness research are described. The competitive landscape is overviewed.</p><p><strong>Expert opinion: </strong>The evidence in this article supports the use of the Mobi-C cervical disc prosthesis as a viable alternative to fusion surgery in selected patients. Mobi-C has a relatively long track record compared to most other cervical disc prostheses. Thus far, Mobi-C is a very good option for preserving cervical motion based on long term follow-up, for achieving favorable clinical outcomes, and for maintaining patient safety. The Mobi-C cervical disc prosthesis is generally viewed positively, supported by clinical experience and research findings.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"15-21"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142916692","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
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