Expert review of medical devices最新文献

Exercise-based cardiac rehabilitation in patients with left ventricular assist devices: an updated systematic review and meta-analysis of randomized controlled trials.

Expert review of medical devices Pub Date : 2025-02-19 DOI: 10.1080/17434440.2025.2468788

Mohamed Abuelazm, Ahmed A Ibrahim, Ahmed Mazen Amin, Mahmoud Shaban, Ubaid Khan, Hazem Rezq, Hossam Elbenawi, Maha T Abuelazm, Mustafa Turkmani, Basel Abdelazeem, Christopher Bianco, Sudarshan Balla

{"title":"Exercise-based cardiac rehabilitation in patients with left ventricular assist devices: an updated systematic review and meta-analysis of randomized controlled trials.","authors":"Mohamed Abuelazm, Ahmed A Ibrahim, Ahmed Mazen Amin, Mahmoud Shaban, Ubaid Khan, Hazem Rezq, Hossam Elbenawi, Maha T Abuelazm, Mustafa Turkmani, Basel Abdelazeem, Christopher Bianco, Sudarshan Balla","doi":"10.1080/17434440.2025.2468788","DOIUrl":"https://doi.org/10.1080/17434440.2025.2468788","url":null,"abstract":"Background: Data on the efficacy and safety of exercise-based cardiac rehabilitation (EBCR) in patients with left ventricular assist devices (LVAD) remains limited. This study aims to pool evidence on EBCR's efficacy and safety in LVAD patients and compare high-intensity (HIIT) versus moderate-intensity (MIIT) regimens.Methods: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) from PubMed, Embase, Cochrane, Scopus, and Web of Science up to January 2024. A fixed-effects model reported dichotomous outcomes using risk ratio (RR) and continuous outcomes using standardized mean difference (SMD) with a 95% confidence interval (CI). The study was registered in PROSPERO under the identifier 'CRD42024506485.'Results: Six RCTs with 160 patients were included. No significant difference was found between EBCR and usual care for peak VO2 change [p = 0.22] and six-minute walk distance (6-MWD) change [p = 0.16]. Similarly, no significant difference was observed between HIIT and MICT for peak VO2 change [p = 0.52] and 6-MWD change [p = 0.61]. Moreover, there was no significant difference between EBCR and usual care regarding the incidence of adverse events [p = 0.09], and between HIIT and MICT exercise [p = 0.71].Conclusion: The evidence suggests EBCR does not improve functional capacity, measured by peak VO2 or 6-MWD, in LVAD patients. However, EBCR is safe, with similar adverse event rates compared to usual care.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143451254","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

Current status and prospects of robot-assisted spine surgery.

Expert review of medical devices Pub Date : 2025-02-17 DOI: 10.1080/17434440.2025.2467779

Zhang Qi, He Da, Fang Yanming, Fan Mingxing

{"title":"Current status and prospects of robot-assisted spine surgery.","authors":"Zhang Qi, He Da, Fang Yanming, Fan Mingxing","doi":"10.1080/17434440.2025.2467779","DOIUrl":"10.1080/17434440.2025.2467779","url":null,"abstract":"Introduction: Traditional spine surgery is frequently impeded by a number of challenges, including the complexity of the underlying anatomy, the depth of the surgical locations, and the limited visibility. These factors can collectively result in prolonged operation times and a reduction in the precision. The advent of robot-assisted spine surgery has brought about a transformative solution, particularly in the context of screw placement. Robot-assisted spine surgery has the potential to enhance accuracy and safety while minimizing soft tissue damage.Areas covered: This article presents a review of the current state of robot systems in spine surgery. The principal advantages of robot-assisted technology include high precision in screw placement, robust imaging capabilities, reduced surgeon fatigue, and the potential for remote operation, thereby addressing disparities in healthcare access. Clinical studies indicate that robot-assisted techniques significantly improve the accuracy of screw placement and may reduce the incidence of postoperative complications. Challenges such as cost, technology limitations, and the need for comprehensive clinical guidelines persist.Expert opinion: It is anticipated that future advancements in surgical navigation, artificial intelligence integration and the expansion of robot functions will further enhance the efficacy of robot-assisted spine surgery, with the potential to improve patient outcomes and facilitate broader adoption in clinical practice.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-6"},"PeriodicalIF":0.0,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143426840","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 use of predetermined change control plans to enable the release of new versions of software as a medical device.

Expert review of medical devices Pub Date : 2025-02-17 DOI: 10.1080/17434440.2025.2468787

Jacques Andre DuPreez, Olivia McDermott

{"title":"The use of predetermined change control plans to enable the release of new versions of software as a medical device.","authors":"Jacques Andre DuPreez, Olivia McDermott","doi":"10.1080/17434440.2025.2468787","DOIUrl":"https://doi.org/10.1080/17434440.2025.2468787","url":null,"abstract":"Objectives: This study investigates how Predetermined Change Control Plans (PCCPs) can support the Software Development Life Cycle (SDLC) of certain Software as a Medical Device (SaMDs).Methods: Targeted surveys collected qualitative and quantitative data on the current regulatory change process for SaMD; the use of PCCPs; the potential parameters of PCCPs in terms of technical, clinical, usability and administrative changes to SaMD; and whether PCCPs could be used more broadly for all SaMD.Results: Results indicate that the current regulatory approach is not fit for purpose, specifically regarding fast-moving SaMD or continuous-learning AI SaMD. There was strong support for PCCPs to cover device technology, usability, and administrative changes, while clinical changes had limited support and required further investigation. The EU lags behind the US and now the UK in addressing these challenges and should look to legislate and implement PCCPs to ensure ongoing innovation and investment in digital health technologies.Conclusion: This work is novel in the gathering of meaningful input from experts, practitioners, and regulatory professionals within the SaMD industry located in the EU, UK and US on the value and need for PCCPs. This study has implications for practice and policy as it can inform SaMD guidance and legislation.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143442967","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

Effectiveness of mental health chatbots in depression and anxiety for adolescents and young adults: a meta-analysis of randomized controlled trials.

Expert review of medical devices Pub Date : 2025-02-16 DOI: 10.1080/17434440.2025.2466742

Tzu Han Chen, Ginger Chu, Ren-Hao Pan, Wei-Fen Ma

{"title":"Effectiveness of mental health chatbots in depression and anxiety for adolescents and young adults: a meta-analysis of randomized controlled trials.","authors":"Tzu Han Chen, Ginger Chu, Ren-Hao Pan, Wei-Fen Ma","doi":"10.1080/17434440.2025.2466742","DOIUrl":"10.1080/17434440.2025.2466742","url":null,"abstract":"Background: The mental health chatbot is dedicated to providing assistance to individuals grappling with the complexities of depression and anxiety.Objective: The study aimed to evaluate the effectiveness of the mental health chatbot in alleviating symptoms of depression and anxiety among adolescents and young adults.Methods: A systematic review framework was employed with a protocol pre-registered on Prospero (CRD42023418877). Databases were systematically searched, including PubMed, ACM Digital Library, Embase, Cochrane and IEEE. Data synthesis was conducted narratively, and meta-analysis was performed by pooling data from the original studies.Results: Ten randomized controlled trials focused on an acute population, mainly females and university students. Chatbots designed for daily conversations and mood monitoring, using cognitive behavioral therapy techniques, showed efficacy in treating depression (95% CI = -1.09 to -0.23; p = .003). However, it is essential to highlight that these interventions utilizing chatbots for mental health were not found to be efficacious in managing symptoms of anxiety (95% CI = -0.56 to 0.4; p = .74).Conclusions: Evidence supports the effectiveness of mental health chatbots in treating depression, but further exploration and refinement are needed to optimize their efficacy in managing anxiety.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-9"},"PeriodicalIF":0.0,"publicationDate":"2025-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143400566","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 E-nside, multi- inner branch-based off-the-shelf stent graft for the treatment of thoracoabdominal aortic aneurysms.

Expert review of medical devices Pub Date : 2025-02-14 DOI: 10.1080/17434440.2025.2465686

Paolo Calo, Miroslav Yordanov, Schäfers Johannes Frederik, Alexander Oberhuber

{"title":"The E-nside, multi- inner branch-based off-the-shelf stent graft for the treatment of thoracoabdominal aortic aneurysms.","authors":"Paolo Calo, Miroslav Yordanov, Schäfers Johannes Frederik, Alexander Oberhuber","doi":"10.1080/17434440.2025.2465686","DOIUrl":"https://doi.org/10.1080/17434440.2025.2465686","url":null,"abstract":"Introduction: Endovascular repair for thoracoabdominal aortic aneurysms (TAAAs) has changed treatment paradigm over the past decades. However for urgent cases, there are not many options available. The E-nside (Artivion, Georgia, U.S.A.) endograft is one of the three off-the-shelf-aortic endografts available on the market. Its unique design with four inner branches and other special features offer more versatility, so more patients could be minimally invasively treated.Areas covered: We present a descriptive review based on market analysis on the available devices and a pubmed literature research on the E-nside endograft. The aim of this article is to present its unique structure, deployment method, cannulation methods and discuss its applicability, indications, associated concerns and an overview of the available alternative devices.Expert opinion: The implantation of the E-nside endograft is a promising technique for treating not only TAAAs but also complex abdominal aortic aneurysm. Unlike FEVAR or BEVAR, which require precise planning and have the disadvantage of long manufacturing time. We think that with the off-the-shelf feature from E-nside endograft this can be obviated, and through its flexible planning along with its simple use, more patients could benefit and so favorable results can be achieve.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143426843","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

Vigilance and medical devices: from theory to the field, the example of electroporation in atrial fibrillation.

Expert review of medical devices Pub Date : 2025-02-11 DOI: 10.1080/17434440.2025.2463340

Cordélia Salomez-Ihl, Marvin Jacquet, Laura Quarteroni, Pascal Defaye, Delphine Schmitt, Philippe Py, Pierrick Bedouch

引用次数: 0

Advancing flow diverter porosity assessment: what can it tell us about occlusion rates?

Expert review of medical devices Pub Date : 2025-02-10 DOI: 10.1080/17434440.2025.2464177

Santiago Estevez-Areco, Laura Obradó, Romina Muñoz, Ignacio Larrabide

引用次数: 0

Is there a role for continuous glucose monitoring beyond diabetes? Emerging applications in new populations.

Expert review of medical devices Pub Date : 2025-02-05 DOI: 10.1080/17434440.2025.2463339

Kevin Cowart, Kevin Olson, Nicholas W Carris

引用次数: 0

Smart clothing for human movement analysis: future application in sport and clinical practice. 用于人体运动分析的智能服装：未来在运动和临床实践中的应用。

Expert review of medical devices Pub Date : 2025-01-01 Epub Date: 2025-01-21 DOI: 10.1080/17434440.2025.2454933

Rachel Mason, Gill Barry, Rodrigo Vitorio, Oisin Lennon, Hugh Robinson, Ben O'Callaghan, Rosie Morris, Alan Godfrey, Samuel Stuart

引用次数: 0

Wearable technology in inflammatory bowel disease: current state and future direction. 炎症性肠病的可穿戴技术：现状和未来方向。

Expert review of medical devices Pub Date : 2025-01-01 Epub Date: 2025-01-15 DOI: 10.1080/17434440.2025.2453561

Sidharth Harindranath, Devendra Desai

{"title":"Wearable technology in inflammatory bowel disease: current state and future direction.","authors":"Sidharth Harindranath, Devendra Desai","doi":"10.1080/17434440.2025.2453561","DOIUrl":"10.1080/17434440.2025.2453561","url":null,"abstract":"Introduction: Wearables are electronic devices worn on the body to collect health data. These devices, like smartwatches and patches, use sensors to gather information on various health parameters. This review highlights the current use and the potential benefit of wearable technology in patients with inflammatory bowel disease (IBD).Areas covered: In this review, we explore the current use of wearable technology in healthcare and the studies applying this technology in patients with IBD. We also discuss the limitations of using digital health data in general and wearable technology in particular in the current clinical paradigm and predict a path forward in how to rationally and effectively apply this technology to improve the care of patients with IBD. A comprehensive search of all suitable studies was conducted using the databases of PubMed, MEDLINE, Embase, and Scopus from inception to August 2024.Expert opinion: Currently, wearable technology is applied to the monitoring of IBD and prediction of flares using devices and sensors. Future applications include early disease detection using biosensors, advanced data collection through ingestible devices, gut microbiome monitoring, and integration with machine learning. These advancements promise to revolutionize disease management, including IBD, by enabling early diagnosis, personalized treatment, and improved patient outcomes.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"121-126"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142967629","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