Expert review of medical devices最新文献_第4页

Promoting the widespread adoption of videolaryngoscopy: addressing resistance to change. 促进视频喉镜的广泛应用：应对变革阻力。

Expert review of medical devices Pub Date : 2024-08-01 Epub Date: 2024-07-24 DOI: 10.1080/17434440.2024.2383376

Manuel Ángel Gómez-Ríos, Teresa López, Alfredo Abad-Gurumeta, José A Sastre

引用次数: 0

Mixed reality in interventional radiology: a focus on first clinical use of XR90 augmented reality-based visualization and navigation platform. 介入放射学中的混合现实技术：聚焦 XR90 增强现实可视化和导航平台的首次临床应用。

Expert review of medical devices Pub Date : 2024-08-01 Epub Date: 2024-07-25 DOI: 10.1080/17434440.2024.2379925

Kyle Finos, Sanjit Datta, Art Sedrakyan, Jeffrey W Milsom, Bradley B Pua

{"title":"Mixed reality in interventional radiology: a focus on first clinical use of XR90 augmented reality-based visualization and navigation platform.","authors":"Kyle Finos, Sanjit Datta, Art Sedrakyan, Jeffrey W Milsom, Bradley B Pua","doi":"10.1080/17434440.2024.2379925","DOIUrl":"10.1080/17434440.2024.2379925","url":null,"abstract":"Introduction: Augmented reality (AR) and virtual reality (VR) are emerging tools in interventional radiology (IR), enhancing IR education, preprocedural planning, and intraprocedural guidance.Areas covered: This review identifies current applications of AR/VR in IR, with a focus on studies that assess the clinical impact of AR/VR. We outline the relevant technology and assess current limitations and future directions in this space. We found that the use of AR in IR lags other surgical fields, and the majority of the data exists in case series or small-scale studies. Educational use of AR/VR improves learning anatomy, procedure steps, and procedural learning curves. Preprocedural use of AR/VR decreases procedure times, especially in complex procedures. Intraprocedural AR for live tracking is accurate within 5 mm live patients and has up to 0.75 mm in phantoms, offering decreased procedure time and radiation exposure. Challenges include cost, ergonomics, rapid segmentation, and organ motion.Expert opinion: The use of AR/VR in interventional radiology may lead to safer and more efficient procedures. However, more data from larger studies is needed to better understand where AR/VR is confers the most benefit in interventional radiology clinical practice.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141763486","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

Evaluations of medical device usability during clinical investigations: a scoping review of clinical study protocols. 临床研究期间的医疗设备可用性评估：临床研究协议的范围审查。

Expert review of medical devices Pub Date : 2024-08-01 Epub Date: 2024-07-09 DOI: 10.1080/17434440.2024.2378093

Laura Douze, Jessica Schiro, Louise Heyndels, Lionel Pazart, Sylvia Pelayo

{"title":"Evaluations of medical device usability during clinical investigations: a scoping review of clinical study protocols.","authors":"Laura Douze, Jessica Schiro, Louise Heyndels, Lionel Pazart, Sylvia Pelayo","doi":"10.1080/17434440.2024.2378093","DOIUrl":"10.1080/17434440.2024.2378093","url":null,"abstract":"Objective: Combining clinical investigations with usability studies provides valuable information for medical devices evaluation. But both types of study are very different in terms of objectives and methodologies. How are usability studies integrated into clinical investigations in practice?Methods: We searched the ClinicalTrials.gov database for clinical investigation protocols that included usability outcome(s) and analyzed them.Results: 77 study protocols were identified for the analysis, including 102 outcomes related to usability in total. The most frequently assessed outcomes were satisfaction (53/102) and ease of use (33/102). The questionnaire was the most frequently planned technique (85/102) followed by interviews (24/102). Other methods were used, such as observation (9/102), mostly when the end users was a healthcare professional, and diary (6/102), mostly with patients.Conclusion: Our study results showed that the collection of usability data can be included in a clinical investigation, with various levels of investment. Resource-light, rapid integration via a questionnaire will enable the collection of subjective data on the users' perceptions. When more resources are available, observation in accessible environments can be set up (especially during use by healthcare professionals in hospital) or interviews and/or diaries for home-based environments (especially by patients).","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141565409","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

Thoracic endovascular aortic repair completion following frozen elephant trunk: how it's done and device selection. 冷冻大象躯干后完成胸腔内血管主动脉修补术：手术方法和器械选择。

Expert review of medical devices Pub Date : 2024-08-01 Epub Date: 2024-07-31 DOI: 10.1080/17434440.2024.2380801

André N Capitain, Bartosz Rylski, Tim Berger, Stoyan Kondov, Philipp Discher, Tim Walter, Nikola Batinkov, Magdalena Bork, Matthias D'Inka, Martin Czerny, Maximilian Kreibich

{"title":"Thoracic endovascular aortic repair completion following frozen elephant trunk: how it's done and device selection.","authors":"André N Capitain, Bartosz Rylski, Tim Berger, Stoyan Kondov, Philipp Discher, Tim Walter, Nikola Batinkov, Magdalena Bork, Matthias D'Inka, Martin Czerny, Maximilian Kreibich","doi":"10.1080/17434440.2024.2380801","DOIUrl":"10.1080/17434440.2024.2380801","url":null,"abstract":"Introduction: Since its introduction in the mid-1990s the frozen elephant trunk (FET) technique has quickly evolved into an effective hybrid treatment option for patients with various thoracic aortic pathologies, acute and chronic. However, a notable incidence of and risk for distal aortic reinterventions persists after the implementation of the FET device. In this review, the authors analyze the indications and outcomes of thoracic endovascular aortic repair completion following FET.Areas covered: For this review, we looked not only at our own data but also searched PubMed for relevant studies, comments, and current recommendations of the European Association for Cardio-Thoracic Surgery (EACTS) and the European Society for Vascular Surgery (ESVS). Additionally, we outline our approach in this 2-stage-treatment plan.Expert opinion: The treatment of acute or chronic aortic pathologies involving the aortic arch frequently requires a 2-stage treatment approach. Sometimes, a tertiary procedure is needed to fix the entire aortic pathology. Thoracic endovascular aortic repair completion following FET requires careful planning to achieve the excellent clinical outcomes that we and numerous other aortic centers have shown. Only a dedicated aortic clinic provides the long-term continuous follow-up required to identify the few patients in need of a tertiary procedure.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141794288","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

Advancing clinical understanding of surface electromyography biofeedback: bridging research, teaching, and commercial applications. 促进对表面肌电图生物反馈的临床理解：连接研究、教学和商业应用。

Expert review of medical devices Pub Date : 2024-08-01 Epub Date: 2024-07-12 DOI: 10.1080/17434440.2024.2376699

Mazen M Yassin, Mohamed N Saad, Ayman M Khalifa, Ashraf M Said

{"title":"Advancing clinical understanding of surface electromyography biofeedback: bridging research, teaching, and commercial applications.","authors":"Mazen M Yassin, Mohamed N Saad, Ayman M Khalifa, Ashraf M Said","doi":"10.1080/17434440.2024.2376699","DOIUrl":"10.1080/17434440.2024.2376699","url":null,"abstract":"Introduction: Expanding the use of surface electromyography-biofeedback (EMG-BF) devices in different therapeutic settings highlights the gradually evolving role of visualizing muscle activity in the rehabilitation process. This review evaluates their concepts, uses, and trends, combining evidence-based research.Areas covered: This review dissects the anatomy of EMG-BF systems, emphasizing their transformative integration with machine-learning (ML) and deep-learning (DL) paradigms. Advances such as the application of sophisticated DL architectures for high-density EMG data interpretation, optimization techniques for heightened DL model performance, and the fusion of EMG with electroencephalogram (EEG) signals have been spotlighted for enhancing biomechanical analyses in rehabilitation. The literature survey also categorizes EMG-BF devices based on functionality and clinical usage, supported by insights from commercial sectors.Expert opinion: The current landscape of EMG-BF is rapidly evolving, chiefly propelled by innovations in artificial intelligence (AI). The incorporation of ML and DL into EMG-BF systems augments their accuracy, reliability, and scope, marking a leap in patient care. Despite challenges in model interpretability and signal noise, ongoing research promises to address these complexities, refining biofeedback modalities. The integration of AI not only predicts patient-specific recovery timelines but also tailors therapeutic interventions, heralding a new era of personalized medicine in rehabilitation and emotional detection.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141536256","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 review: artificial intelligence in image-guided spinal surgery. 综述：人工智能在图像引导脊柱手术中的应用。

Expert review of medical devices Pub Date : 2024-08-01 Epub Date: 2024-08-08 DOI: 10.1080/17434440.2024.2384541

Jiahang Zeng, Qiang Fu

引用次数: 0

MetaHealth: unlocking metaverse technologies in digital healthcare. MetaaHealth：在数字医疗中释放元宇宙技术。

Expert review of medical devices Pub Date : 2024-08-01 Epub Date: 2024-07-22 DOI: 10.1080/17434440.2024.2382233

Smrithy Girijakumari Sreekantan Nair, Balaji Chandrasekaran

{"title":"MetaHealth: unlocking metaverse technologies in digital healthcare.","authors":"Smrithy Girijakumari Sreekantan Nair, Balaji Chandrasekaran","doi":"10.1080/17434440.2024.2382233","DOIUrl":"10.1080/17434440.2024.2382233","url":null,"abstract":"Introduction: The metaverse is a new digital world powered by cutting-edge technologies that offers tremendous potential for healthcare. The metaverse is anticipated to experience enormous growth and adoption with a rising need for digital healthcare over the next decade. This article offers a comprehensive analysis of the integration of metaverse technologies into healthcare.Areas covered: This article delves into the multifaceted realm of metaverse technologies within healthcare, offering insights into its diverse contexts. Central to its exploration are the significant contributions, such as examining the current landscape of metaverse technologies in healthcare, offering a nuanced understanding of their applications. The article meticulously explores the array of tools and platforms available for surgical procedures, highlighting their efficacy and it also delves into how these technologies illuminate the evolving landscape of healthcare delivery. Through thorough analysis, this article elucidates the transformative potential of metaverse technologies in revolutionizing healthcare practices.Expert opinion: The integration of metaverse technologies in healthcare signifies a transformative shift in service delivery. The metaverse, driven by advanced technology, promises substantial changes, enhances medical education, patient care, and research through immersive experiences. This article aims to explore its various contexts heralding a new era in healthcare.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141750098","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

Advancing robot-guided techniques in lumbar spine surgery: a systematic review and meta-analysis. 推进腰椎手术中的机器人引导技术：系统回顾和荟萃分析。

Expert review of medical devices Pub Date : 2024-08-01 Epub Date: 2024-07-15 DOI: 10.1080/17434440.2024.2378080

Temitope Emmanuel Komolafe, Liang Zhou, Wenlong Zhao, Jiachen Guo, Zongdao Li, Zhiping Fan, Blessing Funmi Komolafe, Wang Wei, Oluwarotimi Williams Samuel

{"title":"Advancing robot-guided techniques in lumbar spine surgery: a systematic review and meta-analysis.","authors":"Temitope Emmanuel Komolafe, Liang Zhou, Wenlong Zhao, Jiachen Guo, Zongdao Li, Zhiping Fan, Blessing Funmi Komolafe, Wang Wei, Oluwarotimi Williams Samuel","doi":"10.1080/17434440.2024.2378080","DOIUrl":"10.1080/17434440.2024.2378080","url":null,"abstract":"Background: Lumbar spine surgery is a crucial intervention for addressing spinal injuries or conditions affecting the spine, often involving lumbar fusion through pedicle screw (PS) insertion. The precision of PS placement is pivotal in orthopedic surgery. This systematic review compares the accuracy of robot-guided (RG) surgery with free-hand fluoroscopy-guided (FFG), free-hand without fluoroscopy-guided (FHG), and computed tomography image-guided (CTG) techniques for PS insertion.Methods: A systematic search of various databases from 1 January 2013 to 30 December 2023 was conducted following PRISMA guidelines. Primary outcomes, including PS insertion accuracy and breach rate, were analyzed using a random-effects model. Risk of bias was assessed using the Newcastle-Ottawa Scale.Results: The overall accuracy of PS insertion using RG, based on 37 studies involving 3,837 patients and 22,117 PS, is 97.9%, with a breach rate of 0.021. RG demonstrated superior accuracy compared to FHG and CTG, with breach rates of 3.4 and 0.015 respectively for RG versus FHG, and 3.8 and 0.026 for RG versus CTG. Additionally, RG was associated with reduced mean estimated blood loss compared to CTG, indicating improved safety.Conclusions: The RG is associated with enhanced accuracy of PS insertion and reduced breach rates over other methods. However, additional randomized controlled trials comparing these modalities are needed for further validation.Prospero registration: CRD42023483997.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141617792","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 crucial role of fecal management systems in intensive care. 粪便管理系统在重症监护中的关键作用。

Expert review of medical devices Pub Date : 2024-08-01 Epub Date: 2024-07-30 DOI: 10.1080/17434440.2024.2382881

Tobias Gutting, Andreas Pfützner

{"title":"The crucial role of fecal management systems in intensive care.","authors":"Tobias Gutting, Andreas Pfützner","doi":"10.1080/17434440.2024.2382881","DOIUrl":"10.1080/17434440.2024.2382881","url":null,"abstract":"Introduction: Patients in intensive care units (ICUs) frequently lose control over their fecal continence leading to fecal incontinence (FI). We provide an overview of existing medical devices, which are supposed to alleviate FI-related problems.Areas covered: Fecal management systems (FMS) prevent infections and complications. They reduce the risk of pressure ulcers and fecal incontinence. The systems enhance patient comfort and mitigate emotional distress during illness. Furthermore, FMS facilitate nursing care by reducing the incontinence-related workload. Finally, these systems can help minimize treatment costs by preventing complications, and reduction of extended hospital stays and additional treatments. Several well accepted systems made of silicone are on the market. A polyurethane-based soft balloon FMS (hygh-tec® basic-plus) has also been introduced, offering more comfort to the patient, safer handling for the healthcare professionals, and provides reliable leakproof access to the patient's colon. In addition to contamination-free fecal diversion, the trans-anal sealing mechanism of the device also allows for irrigation and delivery of medication into the colon.Expert opinion: FMS in ICUs are integral to patient care and dignity. Recognizing and prioritizing the importance of these systems is essential for providing the highest standard of care to critically ill patients in the ICU.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141794287","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

Is there a best choice of equipment for colorectal endoscopic submucosal dissection? 结直肠内镜黏膜下剥离术有最佳设备选择吗？

Expert review of medical devices Pub Date : 2024-07-01 Epub Date: 2024-06-04 DOI: 10.1080/17434440.2024.2364022

Francesco Cocomazzi, Sonia Carparelli, Nunzia Labarile, Antonio Capogreco, Marco Gentile, Roberta Maselli, Jahnvi Dhar, Jayanta Samanta, Alessandro Repici, Cesare Hassan, Francesco Perri, Antonio Facciorusso

{"title":"Is there a best choice of equipment for colorectal endoscopic submucosal dissection?","authors":"Francesco Cocomazzi, Sonia Carparelli, Nunzia Labarile, Antonio Capogreco, Marco Gentile, Roberta Maselli, Jahnvi Dhar, Jayanta Samanta, Alessandro Repici, Cesare Hassan, Francesco Perri, Antonio Facciorusso","doi":"10.1080/17434440.2024.2364022","DOIUrl":"10.1080/17434440.2024.2364022","url":null,"abstract":"Introduction: Endoscopic submucosal dissection (ESD) is a widely used technique to remove early neoplastic lesions. It was primarily used in the initial days to treat gastric lesions, but recently, the horizon of this endoscopic procedure has expanded, which has allowed us to manage other technically more complex locations, such as the colorectum.Areas covered: There has been an exponential growth regarding the wide range of devices available in the market for performing colorectal ESD. As a result, the aim of this review is to highlight the indication of this endoscopic technique, which device is best suited for which indication, as well as future trajectories in this field.Expert opinion: Although some devices have proven to be more advantageous than others in this area, very often the choice is still subjective, which is commonly attributed to individual preferences and experience. However, an accurate knowledge of the available tools and their functioning, with their pros and cons, is fundamental for any endoscopist venturing into the field of third space endoscopy. In this way, one can choose which device best suits a particular situation, along with simultaneously having the wealth of knowledge related to therapeutic armamentarium at our disposal in the endoscopy suite.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141201620","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