Expert review of medical devices最新文献_第3页

Securing the internet of medical things in remote patient monitoring and the hospital at home: an interview with Stephen Gilbert. 在远程病人监控和家庭医院中保护医疗物联网：对斯蒂芬·吉尔伯特的采访。

IF 2.7

Expert review of medical devices Pub Date : 2025-09-25 DOI: 10.1080/17434440.2025.2566746

Stephen Gilbert

引用次数: 0

Teleophthalmology enabled devices: bridging the gap in rural eye care. 远程眼科设备：弥合农村眼科护理的差距。

IF 2.7

Expert review of medical devices Pub Date : 2025-09-24 DOI: 10.1080/17434440.2025.2566741

Bharat Gurnani, Kirandeep Kaur

{"title":"Teleophthalmology enabled devices: bridging the gap in rural eye care.","authors":"Bharat Gurnani, Kirandeep Kaur","doi":"10.1080/17434440.2025.2566741","DOIUrl":"https://doi.org/10.1080/17434440.2025.2566741","url":null,"abstract":"Introduction: Rural populations bear a disproportionate burden of preventable vision loss due to scant ophthalmic resources, long travel distances, and delayed diagnoses of vision threatening conditions such as diabetic retinopathy, glaucoma, and age-related macular degeneration. Teleophthalmology leveraging portable imaging devices, data connectivity, and remote interpretation, offers a critical solution by bringing diagnostic capabilities to underserved communities and enabling earlier intervention before irreversible vision loss occurs.Areas covered: This report reviews the evolution and performance of handheld fundus cameras and smartphone-based adapters for ophthalmic imaging, as well as portable and home-based OCT systems for high-resolution structural assessment. We summarize key studies validating device accuracy, and examine artificial-intelligence algorithms that autonomously grade retinal images with regulatory clearance. We also discuss implementation challenges including infrastructure gaps, image-quality limitations, cost-utility data and outline strategies such as hybrid AI - expert workflows, federated learning, and integration of tele-eye care into existing public health programs.Expert opinion: Teleophthalmology devices have matured into reliable tools that can democratize eye care. Their success depends on robust digital infrastructure, rigorous device and algorithm validation, and sustainable financing models. Investment in local training, community engagement, and interoperable referral networks is essential to translate technological advances into meaningful reductions in rural vision impairment.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145133104","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

Expert-involved continuous renal replacement therapy device development: addressing user needs through human factors engineering. 专家参与的持续肾替代治疗设备开发：通过人因工程解决用户需求。

IF 2.7

Expert review of medical devices Pub Date : 2025-09-23 DOI: 10.1080/17434440.2025.2561925

J Choi, C H Park, H Lim, S Kwon, T W Koo, Y Ryu, S Cho, S G Kim, S Lee, H Huh, D K Kim, S Lee, J C Lee

{"title":"Expert-involved continuous renal replacement therapy device development: addressing user needs through human factors engineering.","authors":"J Choi, C H Park, H Lim, S Kwon, T W Koo, Y Ryu, S Cho, S G Kim, S Lee, H Huh, D K Kim, S Lee, J C Lee","doi":"10.1080/17434440.2025.2561925","DOIUrl":"10.1080/17434440.2025.2561925","url":null,"abstract":"Background: Continuous renal replacement therapy (CRRT) devices are essential for critically ill patients but present significant usability challenges that create use-related risks affecting patient safety. This study applied expert-involved usability engineering to develop a user-centered CRRT device.Methods: A three-phase study engaged 233 experts: Phase 1 assessed user needs through an online survey (n = 204) identifying use-related risks. Phase 2 developed and iteratively refined a CRRT prototype through expert review (n = 8) and heuristic evaluation (n = 5). Phase 3 validated the final prototype with ICU nurses (n = 16) through task performance in simulated ICU environments. Main outcomes included user satisfaction scores and use error observations.Results: Phase 1 identified user needs and use-related risks, which were translated into user interface requirements. The initial prototype was developed and refined after iterative usability tests. The final prototype demonstrated high satisfaction scores: Overall User Experience 4.29 ± 0.53, Ease of Use 4.23 ± 0.50, and Comparative Assessment 3.56 ± 0.72. The validation test confirmed effective mitigation of use-related risks. Eight use errors and 48 use difficulties were identified for further refinement.Conclusions: Systematic expert involvement in usability engineering successfully developed a CRRT device that effectively mitigated use-related risks while achieving high user satisfaction, demonstrating the value of expert integration in medical device development.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-14"},"PeriodicalIF":2.7,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145071220","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: The impact of aerosol box on tracheal intubation during the COVID-19 pandemic: a systematic review. 撤回声明：2019冠状病毒病大流行期间气溶胶盒对气管插管的影响：一项系统综述。

IF 2.7

Expert review of medical devices Pub Date : 2025-09-23 DOI: 10.1080/17434440.2025.2563428

引用次数: 0

Visual standardisation of airway devices: can universal colour coding improve outcomes in time-critical settings? 气道设备的视觉标准化：通用颜色编码能否改善时间紧迫情况下的结果？

IF 2.7

Expert review of medical devices Pub Date : 2025-09-23 DOI: 10.1080/17434440.2025.2564356

Anju Gupta, Nitin Choudhary

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Sutureless versus transcatheter aortic valve replacement: propensity matched analysis. 无缝合与经导管主动脉瓣置换术：倾向匹配分析。

IF 2.7

Expert review of medical devices Pub Date : 2025-09-22 DOI: 10.1080/17434440.2025.2563619

Marie Lamberigts, Bert Sarrazin, Delphine Szecel, Filip Rega, Peter Verbrugghe, Christophe Dubois, Bart Meuris

{"title":"Sutureless versus transcatheter aortic valve replacement: propensity matched analysis.","authors":"Marie Lamberigts, Bert Sarrazin, Delphine Szecel, Filip Rega, Peter Verbrugghe, Christophe Dubois, Bart Meuris","doi":"10.1080/17434440.2025.2563619","DOIUrl":"10.1080/17434440.2025.2563619","url":null,"abstract":"Background: The goal of this study is to perform a propensity score matched analysis of sutureless AVR and TAVR to compare patient characteristics and postoperative outcomes including hemodynamic performance.Methods: Patients treated with either sutureless aortic valve replacement (SU-AVR) using PercevalTM or transcatheter aortic valve replacement between October 2017 and June 2022 were included. Propensity score matching (PSM) was used to limit the bias in a non-randomized study.Results: After PSM, 118 pairs of patients were obtained. The in-hospital mortality rate was 0% in SU-AVR and 4.2% in TAVR (p = 0.063). Postoperative complication rates including disabling stroke (0% vs 2.5%, p = 0.250), new need for dialysis (1.7% vs 0%, p = 0.500), and permanent pacemaker implantation at 30 days (5.9% vs 10.2%, p = 0.332) showed no statistical difference. At discharge, TAVR showed significantly lower peak and mean gradients, while paravalvular leakage higher than 1/4 was significantly higher in TAVR (11% vs 0%, p < 0.001).Conclusions: TAVR offers significantly better transprosthetic gradients, shorter ICU and hospital stays, and less need for postoperative dialysis. Surgery using a sutureless valve showed less paravalvular leakage.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-8"},"PeriodicalIF":2.7,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145088631","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}

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Focused transcranial ultrasound stimulation: a breakthrough approach to treating brain disorders. 聚焦经颅超声刺激：治疗脑部疾病的突破性方法。

IF 2.7

Expert review of medical devices Pub Date : 2025-09-18 DOI: 10.1080/17434440.2025.2563618

Sven Vanneste, John Reynolds, Dirk De Ridder

{"title":"Focused transcranial ultrasound stimulation: a breakthrough approach to treating brain disorders.","authors":"Sven Vanneste, John Reynolds, Dirk De Ridder","doi":"10.1080/17434440.2025.2563618","DOIUrl":"10.1080/17434440.2025.2563618","url":null,"abstract":"Introduction: Focused transcranial ultrasound stimulation (fTUS) has emerged as a novel noninvasive technique with promising therapeutic potential for various neurological and psychiatric conditions. The aim of this review is to evaluate current research on fTUS, examining its mechanisms, therapeutic applications, challenges, and future potential in neurological and psychiatric disorders.Area covered: High-intensity fTUS leads to heat-induced thermoablation, which has shown efficacy in treating essential tremor and tremor-dominant Parkinson's disease, with promising outcomes in clinical trials. fTUS has been explored for blood-brain barrier opening, facilitating drug delivery for conditions like glioblastoma and Alzheimer's disease. Low-intensity fTUS can also be used as a novel neuromodulation tool which has shown potential in alleviating chronic pain, depression, and cognitive decline.Expert opinion: Challenges remain, including technical refinements, standardization of parameters, and optimization of therapeutic protocols. Emerging approaches like hyperthermia therapy, sonodynamic therapy, and sonothrombolysis hold promise for future applications. With ongoing research and collaboration, the next decade holds immense potential for further advancements in fTUS technology and its clinical integration.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-12"},"PeriodicalIF":2.7,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145077064","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

Software as medical devices: requirements and regulatory landscape in the United States. 作为医疗设备的软件：美国的要求和监管环境。

IF 2.7

Expert review of medical devices Pub Date : 2025-09-14 DOI: 10.1080/17434440.2025.2561918

Shivani Shah, Priyanka Thakor, Aakash Shah, Om V Singh

{"title":"Software as medical devices: requirements and regulatory landscape in the United States.","authors":"Shivani Shah, Priyanka Thakor, Aakash Shah, Om V Singh","doi":"10.1080/17434440.2025.2561918","DOIUrl":"https://doi.org/10.1080/17434440.2025.2561918","url":null,"abstract":"Introduction: The integration of software into medical devices has profoundly transformed the healthcare landscape, enabling more precise diagnostics, personalized treatment plans, and remote patient monitoring. The rapid pace of software development - especially with emerging technologies like artificial intelligence (AI) and machine learning (ML) - demands specialized regulatory frameworks to ensure patient safety, clinical effectiveness, and product reliability.Areas covered: Software as a Medical Device (SaMD) refers to software intended for medical purposes that operates independently of a physical medical device. This article traces the historical development of regulatory approaches, deconstructs existing frameworks, analyzes key challenges and influencing factors, presents case studies, and anticipates future trends. A narrative literature search was conducted using PubMed, Google Scholar, FDA.gov, EUR-Lex and IMDRF.org, covering materials published between January 2013 and May 2025.Expert opinion: The Total Product Lifecycle (TPLC) framework is essential for managing the evolving performance and risks associated with AI/ML-based SaMD. AI/ML-powered SaMD is not merely transforming healthcare delivery, it is challenging and redefining the foundational assumptions of medical regulation. The regulatory systems must evolve ensuring transparency, maintaining public trust, addressing algorithmic bias, and promoting equitable access to the benefits of these advanced technologies. Innovation must be guided by a framework rooted in safety, integrity, and equity.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145066937","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

Locomotors disability assistive devices for frail persons: An update with focus on advancement in hybrid assistive devices. 为体弱人士设计的运动残疾辅助装置：一种专注于混合辅助装置进步的更新。

IF 2.7

Expert review of medical devices Pub Date : 2025-09-13 DOI: 10.1080/17434440.2025.2560660

Rohit Kumar, Janakarajan Ramkumar, Mohan Gurjar, Siddharth Rai

{"title":"Locomotors disability assistive devices for frail persons: An update with focus on advancement in hybrid assistive devices.","authors":"Rohit Kumar, Janakarajan Ramkumar, Mohan Gurjar, Siddharth Rai","doi":"10.1080/17434440.2025.2560660","DOIUrl":"10.1080/17434440.2025.2560660","url":null,"abstract":"Introduction: The World Health Organization (WHO) reported in 2023 that approximately 1.3 billion people, or 16% of the global population, are living with a disability. Among these, locomotor disabilities constitute a significant portion, underscoring the urgent need for devices that enhance mobility and support daily living. The growing demand for assistive devices highlights the critical importance of tools that foster independence and improve overall health and well-being for individuals with mobility impairments.Area covered: This review provides an update on the existing locomotor assistive devices (LADs), exploring their applications, benefits, limitations, and areas where further advancements are necessary. Special attention is given to hybrid assistive devices, a recent innovation that integrates mobility aids, transfer systems, and rehabilitation tools into a unified platform.Expert opinion: The LADs, particularly hybrid devices, not only promote user autonomy but also alleviate the caregiver demands. Additionally, this review also suggests areas for future research and development, focusing on improving the accessibility, usability, and affordability of LADs to enhance the quality of life for individuals with locomotor disabilities.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-15"},"PeriodicalIF":2.7,"publicationDate":"2025-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145034961","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 EVOQUE Eos system for transcatheter mitral valve replacement: a brief narrative review. EVOQUE Eos系统用于经导管二尖瓣置换术的设备概况：简要回顾。

IF 2.7

Expert review of medical devices Pub Date : 2025-09-12 DOI: 10.1080/17434440.2025.2561242

Michail Penteris, Konstantinos Lampropoulos

{"title":"Device profile of the EVOQUE Eos system for transcatheter mitral valve replacement: a brief narrative review.","authors":"Michail Penteris, Konstantinos Lampropoulos","doi":"10.1080/17434440.2025.2561242","DOIUrl":"10.1080/17434440.2025.2561242","url":null,"abstract":"Introduction: Severe mitral regurgitation (MR) poses significant therapeutic challenges, especially in patients at high surgical risk or unsuitable for transcatheter edge-to-edge repair (TEER). Transcatheter mitral valve replacement (TMVR) has emerged as a viable alternative, with the EVOQUE Eos system representing a next-generation, fully retrievable, transseptal TMVR platform tailored to address prior limitations in safety, anatomical fit, and procedural control.Areas covered: This review outlines the design features, procedural considerations, and early clinical performance of the EVOQUE Eos TMVR system, referencing results from the first-in-human experience and the ongoing MISCEND trial. Furthermore, the EVOQUE Eos is compared with other contemporary TMVR systems. Procedural challenges such as paravalvular leak, left ventricular outflow tract (LVOT) obstruction, bleeding, and hypoattenuated leaflet thickening (HALT) are discussed in context.Expert opinion: The EVOQUE Eos system marks a pivotal advancement in TMVR by offering fully percutaneous access, intuitive deployment, and retrievability. While early outcomes are encouraging, further data are needed to guide patient selection, antithrombotic management, and long-term valve durability. The system may play a central role in the expanding treatment landscape for MR, potentially transforming standard practice in the coming years.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-7"},"PeriodicalIF":2.7,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145034882","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