Expert review of medical devices最新文献_第10页

¹⁸F-FDG PET/CT technology for the assessment of brown adipose tissue: an updated review. 18F-FDG PET/CT技术评估棕色脂肪组织:最新综述

Expert review of medical devices Pub Date : 2023-07-01 Epub Date: 2023-11-24 DOI: 10.1080/17434440.2023.2283618

Maria Ricci, Maria Silvia De Feo, Giorgia Maria Granese, Viviana Frantellizzi, Bruno Carabellese, Ennio Lubrano, Andrea Cimini

{"title":"18F-FDG PET/CT technology for the assessment of brown adipose tissue: an updated review.","authors":"Maria Ricci, Maria Silvia De Feo, Giorgia Maria Granese, Viviana Frantellizzi, Bruno Carabellese, Ennio Lubrano, Andrea Cimini","doi":"10.1080/17434440.2023.2283618","DOIUrl":"10.1080/17434440.2023.2283618","url":null,"abstract":"Introduction: This review provides an update of 18 F-fluorodeoxyglucose ([18F] FDG) for Brown adipose tissue (BAT) activity quantification, whose role is not completely understood.Areas covered: We conducted an unstructured search of the literature for any studies employing the [18F] FDG PET in BAT assessment. We explored BAT quantification both in healthy individuals and in different pathologies, after cold exposure and as a metabolic biomarker. The assessment of possible BAT modulators by using [18F] FDG PET is shown. Further PET tracers and novel developments for BAT assessments are also described.Expert opinion: Further PET tracers and imaging modalities are under investigation, but the [18F] FDG PET is currently the method of choice for the evaluation of BAT and further multicentric trials are needed for a better understanding of the BAT physiopathology, also after cold stimuli. The modulation of BAT activity, assessed by [18F] FDG PET imaging, seems a promising tool for the management of conditions such as obesity and type 2 diabetes. Moreover, an interesting possible correlation of BAT activation with prognostic [18F] FDG PET indices in cancer patients should be assessed with further multicentric trials.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"107593107","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

Preliminary study of 3D printing technology for extracorporeal positioning guide assisted ultrasound-guided microwave ablation of the liver. 三维打印技术用于体外定位引导辅助超声引导微波消融肝脏的初步研究。

Expert review of medical devices Pub Date : 2023-07-01 Epub Date: 2023-11-24 DOI: 10.1080/17434440.2023.2277233

Yu Zhang, Ming-Yue Wang, Li-Kui Wang, Sha Zhang, Hong Sun, Jun Liu

{"title":"Preliminary study of 3D printing technology for extracorporeal positioning guide assisted ultrasound-guided microwave ablation of the liver.","authors":"Yu Zhang, Ming-Yue Wang, Li-Kui Wang, Sha Zhang, Hong Sun, Jun Liu","doi":"10.1080/17434440.2023.2277233","DOIUrl":"10.1080/17434440.2023.2277233","url":null,"abstract":"Background: We designed a 3D-printed extracorporeal positioning guide for assisting ultrasound-guided microwave ablation of the liver and observed its effectiveness.Research design and methods: 13 patients with liver cancer were selected, and their CT data were obtained. The CT data is reconstructed in 3D by computer software Mimics to create a 3D model. The 3D-printed in vitro positioning guides were designed by 3-Matic and fabricated using 3D printing technology. Finally, it is applied to the clinic, and its effect is observed.Results: The preliminary design of a 3D printed extracorporeal positioning guide was applied to the clinic, and the efficiency of assisted ultrasound positioning was 76.92% (10/13), with three patients requiring repositioning. The efficiency of the 3D printed extracorporeal positioning guide technique was 76.92%, a CT examination was performed one month after surgery, and three patients had residual lesions.Conclusions: 3D-printed extracorporeal positioning guides can assist ultrasound in localizing tumors during liver microwave ablation and reduce repeated punctures. It makes percutaneous microwave ablation of the liver more precise and safe. However, the current study sample is small, there are still apparent shortcomings, and long-term clinical studies are needed to prove its effectiveness.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"61567075","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

Recent advances in devices and technologies that might prove revolutionary for colonoscopy procedures. 设备和技术的最新进展可能对结肠镜检查程序具有革命性意义。

Expert review of medical devices Pub Date : 2023-07-01 Epub Date: 2023-11-24 DOI: 10.1080/17434440.2023.2280773

Jonathan S Galati, Kevin Lin, Seth A Gross

{"title":"Recent advances in devices and technologies that might prove revolutionary for colonoscopy procedures.","authors":"Jonathan S Galati, Kevin Lin, Seth A Gross","doi":"10.1080/17434440.2023.2280773","DOIUrl":"10.1080/17434440.2023.2280773","url":null,"abstract":"Introduction: Colorectal cancer (CRC) is the third most common malignancy and second leading cause of cancer-related mortality in the world. Adenoma detection rate (ADR), a quality indicator for colonoscopy, has gained prominence as it is inversely related to CRC incidence and mortality. As such, recent efforts have focused on developing novel colonoscopy devices and technologies to improve ADR.Areas covered: The main objective of this paper is to provide an overview of advancements in the fields of colonoscopy mechanical attachments, artificial intelligence-assisted colonoscopy, and colonoscopy optical enhancements with respect to ADR. We accomplished this by performing a comprehensive search of multiple electronic databases from inception to September 2023. This review is intended to be an introduction to colonoscopy devices and technologies.Expert opinion: Numerous mechanical attachments and optical enhancements have been developed that have the potential to improve ADR and AI has gone from being an inaccessible concept to a feasible means for improving ADR. While these advances are exciting and portend a change in what will be considered standard colonoscopy, they continue to require refinement. Future studies should focus on combining modalities to further improve ADR and exploring the use of these technologies in other facets of colonoscopy.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71490420","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

Clinical benefit of transcutaneous afferent patterned stimulation (TAPS) in essential tremor patients with high unmet need: a secondary analysis of TAPS studies. 经皮传入模式刺激对高未满足需求的特发性震颤患者的临床益处:对TAPS研究的二次分析

Expert review of medical devices Pub Date : 2023-07-01 Epub Date: 2023-11-24 DOI: 10.1080/17434440.2023.2274604

Stuart H Isaacson, Rajesh Pahwa, Salima Brillman, Chiahao Lu, Alexander R Kent

{"title":"Clinical benefit of transcutaneous afferent patterned stimulation (TAPS) in essential tremor patients with high unmet need: a secondary analysis of TAPS studies.","authors":"Stuart H Isaacson, Rajesh Pahwa, Salima Brillman, Chiahao Lu, Alexander R Kent","doi":"10.1080/17434440.2023.2274604","DOIUrl":"10.1080/17434440.2023.2274604","url":null,"abstract":"Background: Transcutaneous afferent patterned stimulation (TAPS) is a noninvasive neuromodulation therapy that improves hand tremor in essential tremor (ET) patients. The benefits of TAPS in ET patients with high unmet need (severe tremor, non-responsive to medication, age ≥65 years) and early responders (substantial TAPS tremor improvement in the first month) remains unknown.Research design and methods: Literature was surveyed for TAPS studies to assess the response in the high unmet need subgroup and early responders. Analyses were performed using previously collected Tremor Research Group Essential Tremor Rating Scale (TETRAS) scores, Bain & Findley activities of daily living (BF-ADL) scores, and tremor power.Results: Significant differences in BF-ADL and TETRAS improvement were observed with TAPS over sham for the high unmet need subgroup in a randomized controlled study (P<0.03). During a 3-month open-label study, the high unmet need subgroup and early responders showed significant improvements in BF-ADL, TETRAS, and tremor power (P<0.001). Analysis of previous real-world evidence demonstrated that early responders maintained effectiveness and usage at 3 and 12 months (P<0.001).Conclusions: TAPS showed comparable improvements in ET with high unmet need as reported in the original studies, and greater efficacy in early responders. These findings inform patient selection and the trial process for identifying TAPS responders.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"50159572","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

Test-retest reliability of pain extent and pain location using a novel pain drawing analysis software application, on patients with shoulder pain. 使用一种新的疼痛绘图分析软件应用程序，在肩部疼痛患者身上测试疼痛程度和疼痛位置的重新测试可靠性。

Expert review of medical devices Pub Date : 2023-07-01 Epub Date: 2023-11-24 DOI: 10.1080/17434440.2023.2277226

Marios Tragoudas, Zacharias Dimitriadis, Adriana Koufogianni, Asimakis Kanellopoulos, Konstantinos Vassis, Panagiotis Gkrilias, Savvas Spanos, Ioannis Poulis

{"title":"Test-retest reliability of pain extent and pain location using a novel pain drawing analysis software application, on patients with shoulder pain.","authors":"Marios Tragoudas, Zacharias Dimitriadis, Adriana Koufogianni, Asimakis Kanellopoulos, Konstantinos Vassis, Panagiotis Gkrilias, Savvas Spanos, Ioannis Poulis","doi":"10.1080/17434440.2023.2277226","DOIUrl":"10.1080/17434440.2023.2277226","url":null,"abstract":"Objectives: A method of pain assessment is the drawing of pain on a specially designed manikin where the patients color the area representing their pain distribution. In recent years, software applications have been developed for the purpose of digital pain drawing data acquisition and processing. Although such specific software applications have already been released, they have been built with obsolete programming tools. The purpose of the study was to investigate the test - retest reliability of a new pain drawing analysis software, in a sample of patients with shoulder pain.Methods: Data collected from 31 subjects with shoulder pain. Participants were asked twice to color their pain distribution in the painting environment of a tablet software application called 'Pain Distribution.'Results: The reliability of pain extent was found to be good (ICC = 0.80). The Jaccard index for the reliability of pain location was found to be moderate, equal to 42.02 ± 19.13%.Conclusion: The results demonstrated good reliability of pain extent and moderate reliability of pain location using the new pain distribution analysis application 'Pain Distribution.' This pain drawing software application could be a reliable, inexpensive, and clinically usable solution for assessing the distribution of pain in patients with shoulder pain.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"61567076","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 orofacial force-related measures using a novel measuring device: explanation of associations with speech rate in dysarthria. 使用一种新型测量设备评估与口面力相关的测量：解释构音障碍患者的言语频率。

Expert review of medical devices Pub Date : 2023-07-01 Epub Date: 2023-11-24 DOI: 10.1080/17434440.2023.2282178

Omid Mohamadi, Farhad Torabinezhad, Mohammad Ali Sanjari, Nazanin Razazian, Abbas Ebadi

{"title":"Evaluation of orofacial force-related measures using a novel measuring device: explanation of associations with speech rate in dysarthria.","authors":"Omid Mohamadi, Farhad Torabinezhad, Mohammad Ali Sanjari, Nazanin Razazian, Abbas Ebadi","doi":"10.1080/17434440.2023.2282178","DOIUrl":"10.1080/17434440.2023.2282178","url":null,"abstract":"Background: The aim of this study was to examine the potential associations between orofacial force-related measures and speech rate in matched groups of 23 adults with dysarthria, and 69 healthy adults.Research design and methods: A novel piezoresistive sensor-based device was utilized to obtain the orofacial maximum forces (OMFs) and rate of force development (RFD) measures. The study computed alternating motion rates (AMRs), sequential motion rates (SMRs), and articulation rate (AR) for all participants. The analysis included between-group comparisons and correlation analyses. The study also examined the reliability of the OMFs and RFD measures.Results: Individuals with dysarthria exhibited significantly slower speech rates (approximately 41.89% to 56.53% slower) compared to the control group. Except for a few exceptions in the jaw, the dysarthria group demonstrated significantly lower OMFs and RFD measures. The correlation analysis revealed that OMFs were weakly to moderately correlated (r = .488-.674) and RFD measures were very weak to moderately correlated (r = .047-.578) with speech rate measures.Conclusions: The findings suggest that reduced OMFs and RFD measures may contribute to the slowed speech rate observed in adults with dysarthria. The study also highlights that OMFs are significantly more reliable (day-to-day) than RFD measures.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71523947","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 value of hip and knee arthroplasty registries. 髋关节和膝关节置换术登记的价值。

Expert review of medical devices Pub Date : 2023-07-01 Epub Date: 2023-11-24 DOI: 10.1080/17434440.2023.2282747

B G Pijls

引用次数: 0

Regulation, approval, and access of spinal implants in low-middle-income countries: a narrative review and case study. 中低收入国家脊柱植入物的监管、批准和使用：叙述性综述和案例研究。

Expert review of medical devices Pub Date : 2023-07-01 Epub Date: 2023-11-24 DOI: 10.1080/17434440.2023.2264767

Chibuikem A Ikwuegbuenyi, Laura-Nanna Lohkamp, Joel Maruthanal, Kassim O Kassim, Hamisi Shabani, Roger Härtl

{"title":"Regulation, approval, and access of spinal implants in low-middle-income countries: a narrative review and case study.","authors":"Chibuikem A Ikwuegbuenyi, Laura-Nanna Lohkamp, Joel Maruthanal, Kassim O Kassim, Hamisi Shabani, Roger Härtl","doi":"10.1080/17434440.2023.2264767","DOIUrl":"10.1080/17434440.2023.2264767","url":null,"abstract":"Introduction: Spinal implants play a vital role in healthcare delivery, and regulations are necessary to ensure their quality, approval, access, and use. In this article, we examine the current state of regulation and approval procedures for medical devices in low- and middle-income countries (LMICs), emphasizing the situation in Tanzania.Areas covered: We conducted a systematic literature search and interviewed a local spine implant representative to investigate the approval, availability, and access of surgical and spinal implants in LMICs, particularly in Africa. Out of the 18 included articles, six referred to African regulations, with no mention of spinal implants. Our analysis revealed that LMICs face challenges in accessing implants due to affordability, poor supply chain, and lack of expertise for their application. However, surgeons have found alternative solutions, such as using lower-cost implants from Turkish manufacturers. The Tanzania Medical Devices and Drugs Authority oversees the local regulatory and approval process for implants.Expert opinion: Regulation and accessibility of spinal implants in LMICs, particularly in Africa, are limited and negatively impact patient care and best medical practice. Potential solutions include capacity building within and collaboration among regulatory organizations to improve regulatory processes and allocating financial resources to qualitative and quantitative implant access.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41125945","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

Hydrus microstent for the treatment of primary open-angle glaucoma: overview of its safety and efficacy. Hydrus微型支架治疗原发性开角型青光眼：安全性和疗效综述。

Expert review of medical devices Pub Date : 2023-07-01 Epub Date: 2023-11-24 DOI: 10.1080/17434440.2023.2259788

Antonio M Fea, Federico Ricardi, Rossella Cariola, Alessandro Rossi

{"title":"Hydrus microstent for the treatment of primary open-angle glaucoma: overview of its safety and efficacy.","authors":"Antonio M Fea, Federico Ricardi, Rossella Cariola, Alessandro Rossi","doi":"10.1080/17434440.2023.2259788","DOIUrl":"10.1080/17434440.2023.2259788","url":null,"abstract":"Introduction: Minimally invasive glaucoma surgeries (MIGS) are now a consolidated reality in many surgical units. The Hydrus Microstent is one of several MIGS devices bypassing trabecular outflow and had excellent results over the years. This article aims to review the key features of the Hydrus Microstent in terms of design, efficacy, and safety.Areas covered: The present review analyses the main characteristics of the device by evaluating the technical and physical details of its functioning. The evidence that supports a clinical decision summarizes the most influential clinical trials and the most accurate systematic reviews.Expert opinion: The Hydrus device has been extensively studied regarding biocompatibility and outflow potential. The subsequent clinical studies have been well-built and proved that the device effectively reduces intraocular pressure (IOP) and the eyedrop load. The device covers almost a quarter of Schlemm's canal circumference, offering at least two advantages: cannulating the Schlemm's canal provides evidence that the device has been implanted correctly; covering a larger area potentially allows to target multiple collector channels or at least areas of active outflow. This scaffold may prove more effective in naïve patients or subjects who used antiglaucoma eyedrops for a limited period, as the prolonged use of hypotonic medications has been associated with the surgical failure of ab interno microhook trabeculotomy.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41160038","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

Advances in deep brain stimulation for the treatment of post-traumatic stress disorder. 脑深部刺激治疗创伤后应激障碍的研究进展。

Expert review of medical devices Pub Date : 2023-07-01 Epub Date: 2023-11-24 DOI: 10.1080/17434440.2023.2280023

Sean M Nestor, Peter Giacobbe, Agessandro Abrahao, Benjamin Davidson, Jennifer S Rabin, Nir Lipsman, Clement Hamani

引用次数: 0