Expert review of medical devices最新文献_第7页

RETRACTED ARTICLE : Comparison of supraglottic airway device vs. endotracheal intubation for initial airway management in out-of-hospital cardiac arrest: a systematic review and meta-analysis. 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：一项系统回顾和荟萃分析。

IF 2.7

Expert review of medical devices Pub Date : 2025-07-01 DOI: 10.1080/17434440.2024.2446384

Yan Tao, Juxia Zhang, Lei Feng

{"title":"RETRACTED ARTICLE : Comparison of supraglottic airway device vs. endotracheal intubation for initial airway management in out-of-hospital cardiac arrest: a systematic review and meta-analysis.","authors":"Yan Tao, Juxia Zhang, Lei Feng","doi":"10.1080/17434440.2024.2446384","DOIUrl":"10.1080/17434440.2024.2446384","url":null,"abstract":"Introduction: Out-of-hospital cardiac arrest (OHCA) is characterized by the cessation of mechanical cardiac activity and voluntary circulation occurring outside of a hospital setting, making it the leading cause of death worldwide. Recently, the optimal approach to airway management has been a subject of controversy.Methods: Follow PRISMA guidelines for systematic evaluation and meta-analysis. The primary outcome was survival assessed by four measures: Restoration of spontaneous circulation, survival to hospital or emergency department, evaluation of functional recovery after PCR (measured at both discharge and 3 months after PCR), and neurological function score at discharge.Results: A total of six RCTs (14,205 patients) were included in the systematic review, and four RCTs (13,053 patients) were included in the meta-analysis. Five studies (83.3%) of RCTs with ETI controls were notable for their high quality, with low risk of bias judged in all 7 domains of the risk assessment scale. Showed an advantage of SGA (compared to ETI) with potential for ROSC (95% CI [1.02 to 1.18], I2 = 48%, p = 0.01) and survival to hospital or emergency department (95% CI [1.01 to 1.17], I2 = 12%, p = 0.02).Conclusions: This systematic review and meta-analysis found a significant association between SGA and the possibility of obtaining ROSC and reaching the hospital or emergency department after CPR in OHCA.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"i-ix"},"PeriodicalIF":2.7,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142883760","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

Minimally invasive and robotic techniques for implantation of ventricular assist devices in patients with heart failure. 心力衰竭患者心室辅助装置植入的微创和机器人技术。

Expert review of medical devices Pub Date : 2025-07-01 Epub Date: 2025-06-15 DOI: 10.1080/17434440.2025.2505672

Nicholas R Hess, Martin Winter, Andrea Amabile, Faaz Ashraf, David J Kaczorowski, Johannes Bonatti

{"title":"Minimally invasive and robotic techniques for implantation of ventricular assist devices in patients with heart failure.","authors":"Nicholas R Hess, Martin Winter, Andrea Amabile, Faaz Ashraf, David J Kaczorowski, Johannes Bonatti","doi":"10.1080/17434440.2025.2505672","DOIUrl":"10.1080/17434440.2025.2505672","url":null,"abstract":"Introduction: Minimally invasive approaches to cardiac surgery have been developing over the last several decades, including less invasive strategies to implantation of durable left ventricular assist devices (LVAD). Less invasive approaches to LVAD insertion aim to reduce surgical trauma and promote shorter hospital stay and recovery times; and for those bridged to heart transplantation, they aim to facilitate later reentry.Areas covered: PubMed was searched from 1980 to present to identify existing literature regarding non-sternotomy approaches to LVAD insertion. This review outlines the history and early attempts of sternal sparing LVAD insertion, commonly utilized surgical approaches in contemporary practice, as well as the experience with concomitant procedures using these approaches. Additionally, a summary of postoperative outcomes described in the literature is provided. Lastly, this review describes the early use of robotic assistance in durable LVAD implantation.Expert opinion: Sternal sparing approaches to LVAD insertion are feasible, safe, and in multiple experiences, have been shown to reduce operative and postoperative blood loss, reoperation, right ventricular dysfunction, and hospital length of stay. The use of surgical robotics in LVAD implantation remains at its infancy but poses a promising avenue to a totally endoscopic approach to durable mechanical assist therapy.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"685-698"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144121799","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

Comments on: 'two-year outcomes using fast-acting sub-perception therapy for spinal cord stimulation: results of a real-world multicenter study in the United States'. 评论：“使用速效亚知觉疗法进行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 : 2025-07-01 Epub Date: 2025-05-14 DOI: 10.1080/17434440.2025.2504451

Qiji Zhou, Jinyu Guo

引用次数: 0

Device-based solutions supporting patients with swallowing problems. 基于设备的解决方案支持吞咽问题的患者。

Expert review of medical devices Pub Date : 2025-07-01 Epub Date: 2025-05-25 DOI: 10.1080/17434440.2025.2508452

Ayodele Sasegbon, Ivy Cheng, Meng Dai, Wanqi Li, Shaheen Hamdy

{"title":"Device-based solutions supporting patients with swallowing problems.","authors":"Ayodele Sasegbon, Ivy Cheng, Meng Dai, Wanqi Li, Shaheen Hamdy","doi":"10.1080/17434440.2025.2508452","DOIUrl":"10.1080/17434440.2025.2508452","url":null,"abstract":"Introduction: Swallowing is a highly complex activity requiring the coordination of numerous muscles within the head and neck through connections from multiple areas within the central nervous system. Dysphagia is common and has long been known to lead to significant adverse effects on morbidity, mortality, and quality of life. Classical approaches toward dysphagia management involve input by clinical deglutologists who teach rehabilitative exercises and recommend alteration of the consistency of food and fluids. However, the evidence base in support of some of these approaches is inconsistent and requires further and larger studies to support their widespread implementation.Areas covered: This paper shall explore some of these novel techniques and explore the evidence that they will alter the future of dysphagia care.Expert opinion: Medical devices form one aspect of these rehabilitation strategies, and over the past decade, numerous novel techniques targeting the complex swallowing sensorimotor pathway or swallowing associated musculature have come to prominence. These include interventions such as noninvasive brain stimulation, swallowing related biofeedback, and peripheral stimulation approaches, developed to bolster existing management methods. The evidence suggests that many of these approaches have the capability to enhance swallowing function and impact dysphagia recovery, however, more evidence is needed.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"699-709"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144096500","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

Home detection of atrial fibrillation using cardiac activity analysis: technologies available to the patient. 心房颤动的家庭检测使用心脏活动分析：技术提供给病人。

Expert review of medical devices Pub Date : 2025-07-01 Epub Date: 2025-05-26 DOI: 10.1080/17434440.2025.2510537

Federica Ricci, Eugenio Mattei, Giovanni Calcagnini, Federica Censi

{"title":"Home detection of atrial fibrillation using cardiac activity analysis: technologies available to the patient.","authors":"Federica Ricci, Eugenio Mattei, Giovanni Calcagnini, Federica Censi","doi":"10.1080/17434440.2025.2510537","DOIUrl":"10.1080/17434440.2025.2510537","url":null,"abstract":"Introduction: Atrial fibrillation (AF) is the most common cardiac arrhythmia, whose incidence and prevalence have increased over the last 20 years and will continue to increase over the next 30 years. It is characterized by irregular atrial activation, leading to complications as stroke and heart failure. Due to its intermittent and asymptomatic nature, diagnosing and monitoring AF is challenging but crucial for effective treatment and prevention of serious complications.Areas covered: This study reviews noninvasive medical devices available for home detection of AF by analyzing cardiac activity through ECG or photoplethysmography (PPG). The review covers the technologies underlying single-lead ECG acquisition and PPG sensors, and describes how these are used, also in combination, in home-use medical devices (including smartwatches and wristbands).Expert opinion: Single-lead ECG and PPG technologies in consumer electronics have revolutionized AF detection, making it more accessible and convenient for patients. Despite some limitations in signal quality and diagnostic scope, these devices offer significant benefits for early AF detection and management. The use of wearable devices, including smartwatches and wristbands, for heart activity monitoring represents a promising advancement in patient-lead healthcare, potentially leading to better outcomes through timely medical intervention and improved patient engagement in managing their condition.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"711-724"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144136525","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

Evaluation of clinical data and regulatory submission characteristics for neuromodulation devices approved via the 510(k) pathway (1996-2024). 通过510(k)途径批准的神经调节装置的临床数据和监管提交特征评估（1996-2024）。

Expert review of medical devices Pub Date : 2025-07-01 Epub Date: 2025-05-29 DOI: 10.1080/17434440.2025.2508869

Bassel Almarie, Felipe Fregni

{"title":"Evaluation of clinical data and regulatory submission characteristics for neuromodulation devices approved via the 510(k) pathway (1996-2024).","authors":"Bassel Almarie, Felipe Fregni","doi":"10.1080/17434440.2025.2508869","DOIUrl":"10.1080/17434440.2025.2508869","url":null,"abstract":"Objectives: The 510(k) pathway is prevalent for medical device approval, yet its integration of clinical data, especially in neuromodulation devices, remains underexplored.Methods: We evaluated neuromodulation devices approved via the 510(k) pathway from 1996 to 2024. Using Natural Language Processing, we traced predicate networks and analyzed clinical data inclusion. Published clinical data were also reviewed.Results: Among 715 medical devices, 31 neuromodulation devices were identified, with 30 having summary documents. The predicate network included 160-related 510(k) approvals; 48 devices (30%) included clinical data, mainly from randomized trials. Nearly 30% of files were untraceable or lacked an FDA summary. Most approvals were based on a single predicate. Seven percent were subject to recalls, all approved without clinical data. Median time-to-approval was significantly longer for devices with clinical data than those without (157 vs. 110 days, p = 0.008). Clinical data from 36 publications included 32 trials and 4 observational studies, with a median Cohen's d of 0.83 (0.27-1.71) and NNT of 4.8 (2.4-7.9). Trials with differing indications from predicates had larger sample sizes.Conclusions: A significant shift toward clinical data inclusion in the 510(k) pathway was observed, particularly for neuromodulation devices. Challenges include balancing safety standards while streamlining approval process.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"739-746"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144153027","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 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

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