Expert review of medical devices最新文献_第2页

A comprehensive overview of real-world evidence in medical device approvals in the United States. 在美国医疗器械批准的真实世界证据的全面概述。

Expert review of medical devices Pub Date : 2025-07-01 Epub Date: 2025-05-28 DOI: 10.1080/17434440.2025.2512041

Swarnali Goswami, Prajakta P Masurkar, Aashrey Kaul

{"title":"A comprehensive overview of real-world evidence in medical device approvals in the United States.","authors":"Swarnali Goswami, Prajakta P Masurkar, Aashrey Kaul","doi":"10.1080/17434440.2025.2512041","DOIUrl":"10.1080/17434440.2025.2512041","url":null,"abstract":"Background: Despite the U.S. Food and Drug Administration (FDA)'s recognition of the value of real-world evidence (RWE) in the evaluation of medical devices, there is a lack of consensus among RWE stakeholders regarding the FDA's specific evidentiary requirements.Research design and methods: This paper reviews the publicly accessible FDA approval documents from January 2020 to July 2024 and describes the intended purpose of RWE incorporated into medical device approvals, i.e. to support claims of safety and/or effectiveness and its impact on the FDA's benefit-risk assessment.Results: Between January 2020 and July 2024, 117 medical devices included RWE in their submissions. Of these, 74 (63.25%) used RWE to support approval, while in 43 (36.75%) submissions, an RWE study was requested by the FDA. The most common submission types were 510(k) and Pre-Market Approval (PMA)-Panel Track (27.4%), followed by PMA-Original (21.9%) and De Novo (19.48%). RWE most frequently supported effectiveness (85.24%), safety (72.97%). Cardiovascular devices accounted for 44% of approvals incorporating RWE, with registry-based studies being the most common data source.Conclusions: This review highlights key areas of FDA feedback on RWE studies, including concerns related to methodology and data quality emphasizing the need for careful selection of real-world data and rigorous study design.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"767-773"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144164168","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

Four-step formula for the Siewert classification of adenocarcinomas of the esophagogastric junction: a computed tomography-based quantitative model. 食管胃交界腺癌Siewert分型的四步公式：基于计算机断层扫描的定量模型。

Expert review of medical devices Pub Date : 2025-07-01 Epub Date: 2025-06-09 DOI: 10.1080/17434440.2025.2510534

Yi-Ting Liu, Yong-Ai Li, Jia-Zheng Li, Yin-Kui Wang, Zi-Fan Chen, Wan-Ying Ji, Qin Feng, Shuang-Xi Li, Xiao-Ting Li, Fang-Jing Hou, Zhao-Bo Zhang, Kan Xue, Fei Shan, Lei Tang, Zi-Yu Li

{"title":"Four-step formula for the Siewert classification of adenocarcinomas of the esophagogastric junction: a computed tomography-based quantitative model.","authors":"Yi-Ting Liu, Yong-Ai Li, Jia-Zheng Li, Yin-Kui Wang, Zi-Fan Chen, Wan-Ying Ji, Qin Feng, Shuang-Xi Li, Xiao-Ting Li, Fang-Jing Hou, Zhao-Bo Zhang, Kan Xue, Fei Shan, Lei Tang, Zi-Yu Li","doi":"10.1080/17434440.2025.2510534","DOIUrl":"10.1080/17434440.2025.2510534","url":null,"abstract":"Objective: This study aimed to develop a novel quantitative methodology to classify the Siewert type on multiplanar reconstructed (MPR) computed tomography (CT) and subsequently guide the diagnosis of adenocarcinoma of the esophagogastric junction.Methods: Patients in the retrospective development and prospective validation cohort 1 were recruited from Peking University Cancer Hospital. Patients in prospective validation cohort 2 were recruited from Changzhi People's Hospital. A streamlined method determined axial/coronal CT slice numbers for the esophagogastric junction (EGJ) and tumor center; then using these slices formulated a Siewert classification system. The CT-based four-step formula for Siewert type (CT-FSFS) is: STEP 1: determining the axial level of the EGJ; STEP 2: distinguishing Type III from Type I/II; STEP 3: predicting Type III misclassified as II; STEP 4: correcting the misclassification using the deflection angle.Results: The CT-FSFS method demonstrated robust accuracy across all three cohorts: 89.5% in the development cohort, 91.0% in validation cohort 1 and 89.7% in validation cohort 2. In differentiating Type I/II from Type III, the formula demonstrated high specificity (96.9%) and positive predictive value (97.1%) in the development cohort.Conclusions: This study presents a reproducible, quantitative Siewert classification method on MPR CT, it may aid preoperative surgical planning.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"747-755"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144176198","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

Robotic assistance in total knee arthroplasty surgery: necessity or trend? 全膝关节置换术中机器人辅助：必要性还是趋势？

Expert review of medical devices Pub Date : 2025-07-01 Epub Date: 2025-05-27 DOI: 10.1080/17434440.2025.2512042

Vicente J León-Muñoz, Joaquín Moya-Angeler

引用次数: 0

A software-based lung function assessment tool: an interview with VoiceMed. 基于软件的肺功能评估工具：与VoiceMed的访谈。

Expert review of medical devices Pub Date : 2025-07-01 Epub Date: 2025-06-09 DOI: 10.1080/17434440.2025.2514006

Luca Panzarella

引用次数: 0

Advances in high-speed vitrectomy - surpassing the speed barrier in retinal surgery: a concise review. 高速玻璃体切除术的进展-超越视网膜手术的速度障碍：简要回顾。

Expert review of medical devices Pub Date : 2025-07-01 Epub Date: 2025-05-19 DOI: 10.1080/17434440.2025.2507969

Nitin Kumar Menia, Aniruddha Agarwal, Nicola Ghazi

{"title":"Advances in high-speed vitrectomy - surpassing the speed barrier in retinal surgery: a concise review.","authors":"Nitin Kumar Menia, Aniruddha Agarwal, Nicola Ghazi","doi":"10.1080/17434440.2025.2507969","DOIUrl":"10.1080/17434440.2025.2507969","url":null,"abstract":"Introduction: There has been a significant improvement in the technique and instrumentation for pars plana vitrectomy systems in the past decades. High-speed vitrectomy has emerged as a transformative advancement in retinal surgery. The use of advanced vitreous cutters operating at significantly higher speeds has revolutionized the approach to complex vitreoretinal procedures.Areas covered: This paper reviews the latest developments in high-speed vitrectomy, focusing on the technological innovations that have driven its evolution, management systems and visualization techniques. The integration of higher cut rates, now exceeding 10,000 cuts per minute, has substantially reduced vitreous traction, minimized iatrogenic retinal tears, and enhanced the safety profile of these surgeries. Clinical outcomes from recent studies demonstrate that high-speed vitrectomy not only reduces operating time but also improves patient recovery with fewer post-operative complications.Expert opinion: The continuous evolution of vitrectomy technology is setting new standards in retinal surgery, promising greater improvements in patient care. High-speed vitrectomy offers faster, safer, precise surgical outcomes, enhancing surgical success rates. Further research directions may include optimizing cutter design, exploring novel fluidics systems, and developing augmented reality tools to enhance surgeon performance and patient outcomes.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"667-673"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144083024","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

Indications and outcomes of revision total ankle arthroplasty. 改良全踝关节置换术的适应症和结果。

Expert review of medical devices Pub Date : 2025-07-01 Epub Date: 2025-05-23 DOI: 10.1080/17434440.2025.2509770

Kevin A Wu, Albert T Anastasio, Joshua A Wu, Julia Ralph, Crystal Jing, Alexandra N Krez, James K DeOrio

{"title":"Indications and outcomes of revision total ankle arthroplasty.","authors":"Kevin A Wu, Albert T Anastasio, Joshua A Wu, Julia Ralph, Crystal Jing, Alexandra N Krez, James K DeOrio","doi":"10.1080/17434440.2025.2509770","DOIUrl":"10.1080/17434440.2025.2509770","url":null,"abstract":"Introduction: Total ankle arthroplasty (TAA) has emerged as an alternative to ankle arthrodesis for managing end-stage ankle arthritis. However, the long-term survival of TAA remains inferior to that of hip and knee replacements, leading to a higher rate of revision TAA. Understanding the indications and outcomes of revision procedures is critical for orthopedic surgeons managing complex ankle pathology.Areas covered: This review explores the indications, surgical considerations, and outcomes associated with revision TAA. A structured literature search was conducted using PubMed and Scopus (January 2000-March 2024) with keywords including 'revision total ankle arthroplasty,' 'implant failure,' 'complications,' and 'biologic augmentation.'Expert opinion: Revision TAA presents unique surgical and biomechanical challenges that require individualized treatment approaches. While it offers pain relief and functional restoration for select patients, outcomes remain less favorable compared to primary TAA. Future advancements in implant technology may improve long-term success rates. Additionally, optimizing patient selection criteria and perioperative protocols will be essential to reducing complications and enhancing outcomes. Further research is needed to refine revision techniques and establish guidelines for managing failed TAA effectively.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"725-737"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144112910","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

Transcutaneous electric nerve stimulation in restless leg syndrome with cirrhosis: a pilot study. 经皮神经电刺激治疗不宁腿综合征伴肝硬化：一项初步研究。

Expert review of medical devices Pub Date : 2025-07-01 Epub Date: 2025-05-20 DOI: 10.1080/17434440.2025.2508872

Swansu Batra, Vimal Kumar Paliwal, Amit Goel, Ankit Gupta, Ravi V Krishna Kishore, Ajay Kumar Mishra, Sachin Garg, Prabhakar Mishra, Vishwas Kapoor

{"title":"Transcutaneous electric nerve stimulation in restless leg syndrome with cirrhosis: a pilot study.","authors":"Swansu Batra, Vimal Kumar Paliwal, Amit Goel, Ankit Gupta, Ravi V Krishna Kishore, Ajay Kumar Mishra, Sachin Garg, Prabhakar Mishra, Vishwas Kapoor","doi":"10.1080/17434440.2025.2508872","DOIUrl":"10.1080/17434440.2025.2508872","url":null,"abstract":"Background: The study aimed to evaluate the effect of transcutaneous electric nerve stimulation (TENS) on restless leg syndrome (RLS) severity, sleep, quality of life, anxiety, and depression in liver cirrhosis patients.Research design and methods: This was single-arm, open label, pilot study. Cirrhosis patients with RLS were evaluated with International RLS Score (IRLSS, scored 0-40 for severity) at baseline and 1, 2, 4, 6 weeks. Sleep quality, quality of life, depression, and anxiety were assessed using Pittsburg Sleep Quality Index (PSQI, 0-21 with poor sleep), RLS Quality of Life Questionnaire (RLSQoL, 18 items, 13 scored 0-15, higher score - good quality of life), Hamilton Depression Rating Scale (HAM-D, scored 0-53 with increasing depression), and Hamilton Anxiety Rating Scale (HAM-A, scored 0 to 56 with increasing anxiety) at baseline and 4 weeks of TENS.Results: Twenty-five patients (mean age 52 ± 9.1 years, 52% females) received TENS. Mean IRLSS improved from 22.28 ± 6.724 to 6.08 ± 5.590, 7.48 ± 7.206, 8.56 ± 6.715, 11.76 ± 5.456 after 1, 2, 4, and 6 weeks. Baseline sleep quality, quality of life, anxiety, and depression scores (9.6 ± 5.1, 73 ± 20.7, 25.4 ± 11.7, 19.2 ± 10.6) improved after 4 weeks of TENS (4.7 ± 3, 94.9 ± 12.5, 8.9 ± 5.7, 7.5 ± 5).Conclusion: Transcutaneous Electric Nerve Stimulation improved RLS symptoms, sleep quality, anxiety, depression, and overall quality of life in cirrhosis patients.Trial registration: Clinical Trial Registry of India - CTRI/2023/06/053734.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"757-765"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144112984","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

Statement of Retraction : Comparison of supraglottic airway device vs. endotracheal intubation for initial airway management in out-of-hospital cardiac arrest: a systematic review and meta-analysis. 缩回声明：院外心脏骤停初始气道管理中声门上气道装置与气管内插管的比较：系统回顾和荟萃分析。

Expert review of medical devices Pub Date : 2025-07-01 Epub Date: 2025-06-09 DOI: 10.1080/17434440.2025.2514920

引用次数: 0

Advantages of three-photon live imaging for deep tissue analysis. 三光子实时成像在深部组织分析中的优势。

Expert review of medical devices Pub Date : 2025-06-27 DOI: 10.1080/17434440.2025.2525497

Mary Ann Go, Mengke Yang, Simon R Schultz

{"title":"Advantages of three-photon live imaging for deep tissue analysis.","authors":"Mary Ann Go, Mengke Yang, Simon R Schultz","doi":"10.1080/17434440.2025.2525497","DOIUrl":"10.1080/17434440.2025.2525497","url":null,"abstract":"Introduction: Three-photon microscopy is an emerging tool for deep tissue imaging with superior spatial resolution. It enables imaging of portions of tissue beyond the typical depth limit of two-photon microscopy.Areas covered: In this review, we give an overview of widely used deep tissue imaging modalities. We highlight the advantages of three-photon microscopy and review its current applications in biomedical research as well as its potential pre-clinical and clinical applications. Finally, we assess the challenges in the widespread use of three-photon live imaging in biomedical research and in clinical translation.Expert opinion: Three-photon microscopy holds great promise as a biomedical research tool. It can uncover insights into the structure and function of tissues beyond what is accessible with two-photon microscopy. It also has promise to be a powerful clinical tool. Future clinical applications include optical biopsies with near instantaneous results and guided surgical resections. A multimodal strategy that combines three-photon technology with a large field of view, low resolution technique may be used to overcome the limited field of view of three-photon microscopy for macroscopic tissue assessment.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-5"},"PeriodicalIF":0.0,"publicationDate":"2025-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144487493","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

Tumor treating fields for glioblastoma: opportunities and drawbacks. 胶质母细胞瘤的肿瘤治疗领域：机遇与缺点。

Expert review of medical devices Pub Date : 2025-06-27 DOI: 10.1080/17434440.2025.2526679

Alessandro Pesce, Mauro Palmieri, Alessandro Frati, Antonio Santoro, Maurizio Salvati

引用次数: 0