Expert review of medical devices最新文献

Clinical trial design in FDA submissions for neuromodulation devices, 1960-2023: a systematic review and meta-analysis. 1960-2023年FDA提交的神经调节装置临床试验设计：系统回顾和荟萃分析。

Expert review of medical devices Pub Date : 2025-06-21 DOI: 10.1080/17434440.2025.2524450

Bassel Almarie, Kevin Pacheco-Barrios, Anna Carolyna Gianlorenco, Yasmin Eltawil, Alma Sanchez, Felipe Fregni

{"title":"Clinical trial design in FDA submissions for neuromodulation devices, 1960-2023: a systematic review and meta-analysis.","authors":"Bassel Almarie, Kevin Pacheco-Barrios, Anna Carolyna Gianlorenco, Yasmin Eltawil, Alma Sanchez, Felipe Fregni","doi":"10.1080/17434440.2025.2524450","DOIUrl":"https://doi.org/10.1080/17434440.2025.2524450","url":null,"abstract":"Introduction: Integration of clinical trials into FDA approval processes is essential for ensuring the safety and efficacy of neuromodulation devices.Methods: From 1960 to 2023, 125 FDA-approved neuromodulation records corresponding to 109 publications (64 randomized, 45 nonrandomized trials) were identified. Regulatory records and published trial characteristics were reviewed.Results: Safety outcomes were reported in 95.4% of randomized and 82.2% of nonrandomized trials, with serious adverse events in ~ 75% of studies. Efficacy analyses showed small Cohen's d effect sizes in 65.85% of outcomes, medium in 24.39%, and large in 9.76%, with a median NNT of 4.65. Industry funded 87.5% of randomized trials, and conflicts of interest were disclosed in 92.2% of publications. Approximately 20% of devices were recalled - exclusively invasive. Randomized trials had larger sample sizes (median 152 subjects) than nonrandomized studies (median 53; p < 0.001), and study duration varied significantly by indication (p < 0.001).Conclusions: Our findings reveal considerable heterogeneity in the evidence supporting neuromodulation devices, with trials showing systematic safety documentation but modest efficacy. Industry-funded trials dominate the evidence base, with recalls primarily limited to invasive technologies. Evidence gaps persist in minority representation and longitudinal data.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144340779","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

Unlocking the brain's secrets: the NeuroEXPLORER revolution in PET imaging. 解开大脑的秘密：PET成像中的神经探索者革命。

Expert review of medical devices Pub Date : 2025-06-19 DOI: 10.1080/17434440.2025.2522822

Luca Filippi, Roberta Danieli

引用次数: 0

Letter to the editor on 'the potential power of neuralink - how brain-machine interfaces can revolutionize medicine'. 给编辑的关于“神经连接的潜在力量——脑机接口如何革新医学”的信。

Expert review of medical devices Pub Date : 2025-06-17 DOI: 10.1080/17434440.2025.2521393

Dalmacito A Cordero

引用次数: 0

Artificial intelligence and machine learning-driven design of self-healing biomedical composites. 人工智能和机器学习驱动的自修复生物医学复合材料设计。

Expert review of medical devices Pub Date : 2025-06-17 DOI: 10.1080/17434440.2025.2520291

Senthil Maharaj Kennedy, Amudhan K, Padmapriya K, Jeen Robert Rb

{"title":"Artificial intelligence and machine learning-driven design of self-healing biomedical composites.","authors":"Senthil Maharaj Kennedy, Amudhan K, Padmapriya K, Jeen Robert Rb","doi":"10.1080/17434440.2025.2520291","DOIUrl":"10.1080/17434440.2025.2520291","url":null,"abstract":"Introduction: The integration of Artificial Intelligence (AI) and Machine Learning (ML) has significantly enhanced the development of self-healing composites, especially in biomedical fields including tissue engineering, medication delivery, and implantable devices. These materials are designed to self-repair damage, enhancing durability, patient safety, and operational reliability. Considering that traditional materials may deteriorate under physiological conditions, intelligent self-healing composites augmented by AI/ML offer a revolutionary alternative.Areas covered: This work examines current progress in AI- and ML-facilitated design, selection, and optimization of self-healing composites for biomedical applications. Attention is directed toward the application of supervised and unsupervised learning methodologies - such as Bayesian optimization, neural networks, and support vector machines to improve healing efficiency by 30-50%, decrease formulation time by approximately 40%, and achieve predictive accuracies of over 90% regarding failure or healing behavior in specific studies.Expert opinion: The research examines ethical aspects, encompassing data protection, algorithmic transparency, and adherence to regulatory standards such as FDA and ISO 10,993. The paper emphasizes the transformational potential of AI/ML in facilitating intelligent, responsive, and patient-specific composite designs, while also addressing possible issues such as dataset bias and algorithmic opacity. The results indicate that AI-enhanced self-healing systems will be pivotal in the future of customized medicine.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-19"},"PeriodicalIF":0.0,"publicationDate":"2025-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144304093","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

Response to letter to the editor on 'the potential power of Neuralink - how brain-machine interfaces can revolutionize medicine'. 回复给编辑的关于“神经连接的潜在力量——脑机接口如何彻底改变医学”的信。

Expert review of medical devices Pub Date : 2025-06-17 DOI: 10.1080/17434440.2025.2521399

Rahul Kumar, Ethan Waisberg, Joshua Ong, Andrew G Lee

引用次数: 0

Patient-specific plates for distal radius osteotomy: a review of the literature and a parametric plate design concept. 桡骨远端截骨的患者特异性钢板：文献回顾和参数化钢板设计概念。

Expert review of medical devices Pub Date : 2025-06-16 DOI: 10.1080/17434440.2025.2519477

Emilia Gryska, Dimitrios Zarkadas, Charlotte Stor Swinkels, Katleen Libberecht, Anders Björkman

{"title":"Patient-specific plates for distal radius osteotomy: a review of the literature and a parametric plate design concept.","authors":"Emilia Gryska, Dimitrios Zarkadas, Charlotte Stor Swinkels, Katleen Libberecht, Anders Björkman","doi":"10.1080/17434440.2025.2519477","DOIUrl":"10.1080/17434440.2025.2519477","url":null,"abstract":"Introduction: Distal radius fractures are the most common fractures in the body. While the majority heal well, some cases result in symptomatic malunion requiring surgical correction via osteotomy. Virtual surgical planning and patient-specific surgical guides are now widely used to improve precision over traditional two-dimensional planning and freehand osteotomy. However, these procedures almost exclusively use off-the-shelf plates that may not fit a patient's anatomy well. 3D-designed patient-specific plates (PSPs) provide a precise fit, overcoming the limitations of off-the-shelf plates.Areas covered: We summarized the literature on PSPs for correcting distal radius malunion available in May 2025 using PubMed, and reference and citation screening. We discussed the outcomes, design considerations, and cost. We further proposed a parametric plate design concept. Lastly, we discussed design requirements and regulatory aspects of PSPs.Expert opinion: PSPs eliminate the need to compromise the virtual surgical plan to match the off-the-shelf plate, leading to more accurate and stable corrections. The parametric approach offers a more cost-effective alternative to designing PSPs, but further research is needed. Successful integration of parametric PSPs into clinical routine will require investments from plate manufacturers. Future studies will likely compare outcomes with off-the-shelf plates and PSPs in patients and 3D-printed bone models.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-8"},"PeriodicalIF":0.0,"publicationDate":"2025-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144277051","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 : 2025-06-15 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":"1-14"},"PeriodicalIF":0.0,"publicationDate":"2025-06-15","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

Methodologies for the benefit-risk analysis of medical devices: a systematic review. 医疗器械收益-风险分析方法：系统综述。

Expert review of medical devices Pub Date : 2025-06-15 DOI: 10.1080/17434440.2025.2517168

Oscar Freyer, Fatemeh Jahed, Max Ostermann, Mirko Feig, Stephen Gilbert

{"title":"Methodologies for the benefit-risk analysis of medical devices: a systematic review.","authors":"Oscar Freyer, Fatemeh Jahed, Max Ostermann, Mirko Feig, Stephen Gilbert","doi":"10.1080/17434440.2025.2517168","DOIUrl":"10.1080/17434440.2025.2517168","url":null,"abstract":"Introduction: The use of medical devices (MDs) carries both benefits and risks. Regulatory frameworks mandate the weighing of both through a benefit-risk analysis (BRA). This review aims to identify existing BRA methodologies and evaluate their strengths and weaknesses to evaluate their sufficiency in guiding developers and regulators.Methods: A literature search following PRISMA-S was conducted in five databases. Peer-reviewed publications were included when they described BRA methodologies for MDs. Publications on unrelated technologies, pharmaceuticals, non-English publications, and with insufficient descriptions were excluded. The methods were summarized and assessed for their degree of objectivity and for the use of numerical calculations.Results: The search identified 918 records, with 17 meeting the inclusion criteria, describing 16 methods. The methods varied in their reliance on numerical calculations and their degree of objectivity, with a significant correlation between both.Conclusion: Our findings indicate that quantitative methods involve subjective decisions, particularly in endpoint identification and relevance assignment, which means they cannot eliminate the subjectivity and bias for which qualitative methods are criticized. The findings support previous observations of ambiguity in the regulatory process, amplified by technologies with hard-to-quantify risks, and suggest that current BRA methodologies are often limited and may be insufficient to guide developers and regulators.Protocol registration: https://doi.org/10.17605/OSF.IO/RT4SV, identifier is osf.io/rt4sv.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-14"},"PeriodicalIF":0.0,"publicationDate":"2025-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144259682","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

Integration of artificial intelligence into cardiac ultrasonography practice. 将人工智能融入心脏超声检查实践。

Expert review of medical devices Pub Date : 2025-06-11 DOI: 10.1080/17434440.2025.2517171

Shlomo Y Shaulian, Dhir Gala, Amgad N Makaryus

{"title":"Integration of artificial intelligence into cardiac ultrasonography practice.","authors":"Shlomo Y Shaulian, Dhir Gala, Amgad N Makaryus","doi":"10.1080/17434440.2025.2517171","DOIUrl":"10.1080/17434440.2025.2517171","url":null,"abstract":"Introduction: Over the last several decades, echocardiography has made numerous technological advancements, with one of the most significant being the integration of artificial intelligence (AI). AI algorithms assist novice operators to acquire diagnostic-quality images and automate complex analyses.Areas covered: This review explores the integration of AI into various echocardiographic modalities, including transthoracic, transesophageal, intracardiac, and point-of-care ultrasound. It examines how AI enhances image acquisition, streamlines analysis, and improves diagnostic performance across routine, critical care, and complex cardiac imaging. To conduct this review, PubMed was searched using targeted keywords aligned with each section of the paper, focusing primarily on peer-reviewed articles published from 2020 onward. Earlier studies were included when found to be foundational or frequently cited. The findings were organized thematically to highlight clinical relevance and practical applications.Expert opinion: Challenges persist in clinical application, including algorithmic bias, ethical concerns, and the need for clinician training and AI oversight. Despite these, AI's potential to revolutionize cardiovascular care through precision and accessibility remains unparalleled, with benefits likely to far outweigh obstacles if appropriately applied and implemented in cardiac ultrasonography.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-11"},"PeriodicalIF":0.0,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144251514","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 iTind temporary implantable nitinol device for benign prostatic hyperplasia. 用于良性前列腺增生的iTind临时植入式镍钛诺装置的装置简介。

Expert review of medical devices Pub Date : 2025-06-10 DOI: 10.1080/17434440.2025.2517173

Levi Godard, Hersh Trivedi, Gopal Narang, Connor M Forbes

引用次数: 0