Expert review of medical devices最新文献_第10页

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

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

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

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":"Introduction: 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.Areas covered: 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.Expert opinion: 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).","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

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":"Introduction: 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.Areas covered: 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.Expert opinion: 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.","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

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":"Background: 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.Research design and methods: 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.Results: 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; p < 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).Conclusion: 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.Trial registration: ClinicalTrials.gov (CT.gov identifier: NCT01550575).","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

Assessment of glaucoma with retinal nerve fiber layer optical density ratios from volumetric optical coherence tomography across various analytical radii. 通过不同分析半径的体积光学相干断层扫描评估视网膜神经纤维层光密度比对青光眼的影响。

Expert review of medical devices Pub Date : 2025-01-01 Epub Date: 2025-01-02 DOI: 10.1080/17434440.2024.2448337

Binyao Chen, Shirong Chen, Jianling Yang, Mingzhi Zhang

{"title":"Assessment of glaucoma with retinal nerve fiber layer optical density ratios from volumetric optical coherence tomography across various analytical radii.","authors":"Binyao Chen, Shirong Chen, Jianling Yang, Mingzhi Zhang","doi":"10.1080/17434440.2024.2448337","DOIUrl":"10.1080/17434440.2024.2448337","url":null,"abstract":"Objective: To explore the impact of glaucoma on the retinal nerve fiber layer (RNFL) optical density ratio (ODR) by volumetric optical coherence tomography (OCT) under different analytical radii.Methods: Twenty-five eyes identified as healthy and 57 eyes with a glaucoma diagnosis (23 mild and 34 moderate-advanced cases) underwent volumetric OCT scans centered at the optic nerve head. Cross-sectional images were obtained through 5 distinct analytical circles with varying radii. The distribution of RNFL ODRs was analysis and compared between normal eyes and glaucomatous eyes.Results: RNFL ODRs displayed significant variation in relation to their location across all examined eyes and respected the ISTN rule (inferior > superior > nasal > temporal, all p < 0.05). The ODRs differed significantly between normal and glaucomatous groups (all p < 0.001), decreasing as glaucoma progresses, both on average and in each quadrant of all analytical circles (all p < 0.001). The RNFL ODRs correlated significantly with the MD (R2 ranging from 0.553 to 0.585, all p < 0.001), with the most pronounced difference noted in the inferior-temporal sector between groups.Conclusions: RNFL ODRs by OCT imaging could serve as a valuable tool for detecting retinal nerve fiber defects in glaucomatous eyes.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"89-98"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142924309","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

Could one strategy fit all? A comparison of regulatory guidance from China, Europe, and the USA on medical device clinical evaluation throughout the total product lifecycle. 一种策略能适合所有人吗？中国、欧洲和美国医疗器械全生命周期临床评价监管指南的比较

Expert review of medical devices Pub Date : 2025-01-01 Epub Date: 2025-01-02 DOI: 10.1080/17434440.2024.2448848

Gui Su

{"title":"Could one strategy fit all? A comparison of regulatory guidance from China, Europe, and the USA on medical device clinical evaluation throughout the total product lifecycle.","authors":"Gui Su","doi":"10.1080/17434440.2024.2448848","DOIUrl":"10.1080/17434440.2024.2448848","url":null,"abstract":"Introduction: The China National Medical Product Administration (NMPA), European Commission, and United States Food and Drug Administration (FDA) follow similar principles to establish regulatory requirements for medical device clinical evaluations throughout the total product lifecycle (TPLC). However, critical differences in these requirements may have led to different regulatory clinical evaluation strategies in the three jurisdictions. A thorough understanding of these differences is crucial for developing effective global regulatory strategies.Areas covered: PubMed and Embase databases were searched for relevant articles published over the past 20 years. The common ground and unique regulatory requirements for TPLC clinical evaluation of the NMPA, European Commission, and FDA were analyzed, with a particular focus on three premarket clinical evaluation strategies: clinical data or evaluation exemption, using existing clinical data, and generating new clinical data by conducting a clinical trial.Expert opinion: Because of critical differences in regulatory requirements, the same clinical strategy may not be suitable for all three regulatory jurisdictions. When using the same premarket regulatory clinical evaluation approach, the time and cost investments for new product registration in the three regulatory jurisdictions could differ. A TPLC clinical evaluation strategy is critical for the time and cost assessment of a global regulatory strategy.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"5-13"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142924310","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

Comparison of 6-lead smartphone ECG and 12-lead ECG in athletes and a genetic heart disease population. 比较运动员和遗传性心脏病人群的 6 导联智能手机心电图和 12 导联心电图。

Expert review of medical devices Pub Date : 2025-01-01 Epub Date: 2024-12-17 DOI: 10.1080/17434440.2024.2443113

Angus J Davis, John W Orchard, Daniel McGhie, Daniel Broadbridge, Hariharan Raju, Andre La Gerche, Rajesh Puranik, Belinda Gray, Jennifer De Jongh, Tim Driscoll, Jessica J Orchard

{"title":"Comparison of 6-lead smartphone ECG and 12-lead ECG in athletes and a genetic heart disease population.","authors":"Angus J Davis, John W Orchard, Daniel McGhie, Daniel Broadbridge, Hariharan Raju, Andre La Gerche, Rajesh Puranik, Belinda Gray, Jennifer De Jongh, Tim Driscoll, Jessica J Orchard","doi":"10.1080/17434440.2024.2443113","DOIUrl":"10.1080/17434440.2024.2443113","url":null,"abstract":"Background: Smartphone electrocardiograms (iECGs) are an innovative method of capturing transient arrhythmias that are occasionally experienced by athletes. This study aimed to assess the accuracy of a 6-lead iECG compared with 12-lead ECG in athletes and those with known genetic heart disease (positive controls).Research design and methods: Each participant had a resting 12-lead ECG (supine) and a 30 s 6-lead iECG (seated) taken within 2 h. Manual measurements of heart rate, QTc, and PR intervals, and QRS duration were completed using digital calipers. Bland-Altman analysis was used to assess the quantitative agreement of measurements.Results: The 6-lead readings for heart rate were faster than the 12-lead in athletes (n = 233) and positive controls (n = 49). All other measurements were shorter in the 6-lead. QTc mean difference was smaller in the positive controls (4.7 ± 26.0 ms) than in athletes (12.5 ± 25.0 ms). The largest difference was in PR intervals, both in athletes (12.8 ± 17.7 ms) and positive controls (7.6 ± 18.9 ms). QRS duration had the smallest mean difference (0.6 ± 9.0 ms in athletes, 1.0 ± 12.7 ms in positive controls).Conclusions: The 6-lead readings had reasonable agreement with the 12-lead ECG. A 6-lead iECG is a reasonable option to opportunistically capture arrhythmias that may occur infrequently, but should not replace a 12-lead if available.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"99-105"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142819783","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 'Japanese paradox' of total hip arthroplasty: where are we going? 全髋关节置换术的“日本悖论”：我们将何去何从？

Expert review of medical devices Pub Date : 2025-01-01 Epub Date: 2025-01-02 DOI: 10.1080/17434440.2024.2448741

Kenichi Oe, Hirokazu Iida, Takanori Saito

{"title":"The 'Japanese paradox' of total hip arthroplasty: where are we going?","authors":"Kenichi Oe, Hirokazu Iida, Takanori Saito","doi":"10.1080/17434440.2024.2448741","DOIUrl":"10.1080/17434440.2024.2448741","url":null,"abstract":"Introduction: There is a worldwide trend toward 'revisiting' cemented total hip arthroplasty (THA). In Japan, however, cemented THAs accounts for 11%, and the percentage of cemented hemiarthroplasty is estimated to be less than 10%. This review was designed to reconsider the option of cemented THA and to encourage policy changes in Japan to support the best possible care for patients.Area covered: In this article, we reviewed the history of THA and the current situations of the world, based on past reports and nationwide registries. Merits and demerits of cemented THA were evaluated from various perspectives.Expert opinion: Cemented THA had great advantages, including establishment of the acetabular cup, diversity of the femoral stem, antibiotic-loaded acrylic cement, revision, low incidence of periprosthetic fracture, and hemiarthroplasty. In patients older than 75 years of age, cemented THA resulted in the lowest risk of revision. Guidelines for femoral neck fracture recommended the use of cemented hemiarthroplasty in many countries because of low incidence of periprosthetic fracture. Numerous contradictions regarding implant price and cost of operations have also been noted in Japan. For the patients, we need to rethink what is truth and what is fiction.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"31-48"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142924311","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