Expert review of medical devices最新文献_第2页

How can we develop transcranial direct current stimulation into an effective at-home treatment tool for depression? 如何将经颅直流电刺激发展成一种有效的居家抑郁症治疗工具？

Expert review of medical devices Pub Date : 2024-10-01 Epub Date: 2024-09-26 DOI: 10.1080/17434440.2024.2409767

Ulrike Vogelmann, Giuseppina Pilloni, Andre R Brunoni, Leigh Charvet

引用次数: 0

Evaluation and management of coronary artery disease in transcatheter aortic valve implantation candidates with severe aortic stenosis and coronary artery disease: technology and techniques. 对患有严重主动脉瓣狭窄和冠状动脉疾病的经导管主动脉瓣植入术候选者的冠状动脉疾病进行评估和管理：技术和技巧。

Expert review of medical devices Pub Date : 2024-10-01 Epub Date: 2024-09-13 DOI: 10.1080/17434440.2024.2401492

Giulia Laterra, Orazio Strazzieri, Claudia Reddavid, Lorenzo Scalia, Federica Agnello, Salvatore Lavalle, Marco Barbanti

{"title":"Evaluation and management of coronary artery disease in transcatheter aortic valve implantation candidates with severe aortic stenosis and coronary artery disease: technology and techniques.","authors":"Giulia Laterra, Orazio Strazzieri, Claudia Reddavid, Lorenzo Scalia, Federica Agnello, Salvatore Lavalle, Marco Barbanti","doi":"10.1080/17434440.2024.2401492","DOIUrl":"10.1080/17434440.2024.2401492","url":null,"abstract":"Introduction: Patients with severe aortic stenosis referred for transcatheter aortic valve implantation (TAVI) often present with concomitant coronary artery disease (CAD). The management of CAD in these patients remains a topic of debate, encompassing the evaluation and timing of percutaneous coronary intervention (PCI).Areas covered: This review article aims to offer an overview of the role of coronary revascularization in TAVI patients, highlighting the advantages and disadvantages of different strategies: PCI before, concomitant with, and after TAVI. Considering that TAVI indications are expanding and patients with low surgical risk are now being referred for TAVI, the rate of PCI among patients undergoing TAVI is expected to increase. Historically, PCI was performed before TAVI. However, there is now a growing trend to defer PCI until after TAVI.Expert opinion: It is plausible that in the future, there will be an increase in PCI after TAVI due to several factors: first, multiple studies have shown the safety of TAVI even in patients with severe untreated CAD; second, improvements in TAVI device implantation techniques, such as commissural alignment and patient-specific device selection, have improved access to the coronary arteries post-TAVI.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142157046","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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Atrial flow regulators for the treatment of pulmonary arterial hypertension: what does the future hold? 用于治疗肺动脉高压的心房血流调节器：前景如何？

Expert review of medical devices Pub Date : 2024-10-01 Epub Date: 2024-10-04 DOI: 10.1080/17434440.2024.2409769

Oliver E Aregullin, Reda E Girgis, Sheila Krishnan

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Delivery systems for transcatheter therapies of congenital heart disease. 先天性心脏病经导管疗法的输送系统。

Expert review of medical devices Pub Date : 2024-10-01 Epub Date: 2024-09-13 DOI: 10.1080/17434440.2024.2402034

Ralf J Holzer, Ziyad M Hijazi

{"title":"Delivery systems for transcatheter therapies of congenital heart disease.","authors":"Ralf J Holzer, Ziyad M Hijazi","doi":"10.1080/17434440.2024.2402034","DOIUrl":"10.1080/17434440.2024.2402034","url":null,"abstract":"Introduction: Delivery systems are crucially important for the implantation of medical devices in patients with congenital heart disease. However, very little data is available comparing the advantages and disadvantages of the various delivery systems.Areas covered: This article describes the delivery systems and methods used for delivery of atrial septal occluder devices, ventricular septal occluder devices, devices to occlude patent arterial ducts, and transcatheter pulmonary valves. Delivery systems are compared relating to prepping and loading, positioning of the delivery sheath/catheter, deployment, ability to recapture and reposition, as well as device release.Expert opinion: For most ASD/VSD/PDA occluder devices, the basic delivery mechanism has changed very little over the preceding 20 years. Future modifications may focus on meaningful modifications to the cable systems that reduce stiffness and improve angulation at the connection to the device. Over the next 5-10 years, it is expected to see significant changes to delivery systems used for transcatheter pulmonary valve implantation, that result in improvements in the ability to recapture and reposition self-expandable transcatheter valves during the deployment process, combined with kink resistant sheaths that facilitate easy tracking across often complex right ventricular outflow tracts.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142157045","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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Correlations among parameters of pentacam, iTrace, and LOCS III in assessing lens opacity. 评估晶状体混浊的 pentacam、iTrace 和 LOCS III 参数之间的相关性。

Expert review of medical devices Pub Date : 2024-10-01 Epub Date: 2024-09-04 DOI: 10.1080/17434440.2024.2355294

Liu Li, Ying-Jie Li, Miao Liu, Yu Jin

{"title":"Correlations among parameters of pentacam, iTrace, and LOCS III in assessing lens opacity.","authors":"Liu Li, Ying-Jie Li, Miao Liu, Yu Jin","doi":"10.1080/17434440.2024.2355294","DOIUrl":"10.1080/17434440.2024.2355294","url":null,"abstract":"Objectives: To investigate the diagnostic value of iTrace visual function analyzer, Pentacam 3D anterior segment analysis system and Lens Opacities Classification System III (LOCS III) in assessing lens opacity in patients with age-related cataract (ARC).Methods: A total of 129 patients with ARC admitted to Anonymized from May 2019 to April 2021 were selected as the research objects. The degree of lens opacity was evaluated by LOCS III classification, iTrace and anterior segment analysis.Results: The Pentacam nucleus staging (PNS) grade was strongly correlated with nuclear color (NC) (r = 0.537, p < 0.05) and moderately correlated with nuclear opalescence (NO) (r = 0.473, p < 0.05). The integrated density (IntDen) in 3-mm nuclear region was strongly correlated with NC (r = 0.548, p < 0.05) and NO (r = 0.539, p < 0.05). The dysfunctional lens index (DLI) in 3-mm area was negatively correlated with NC (r=-0.252, p < 0.05), NO (r=-0.239, p < 0.05) and posterior subcapsular cataract (r=-0.271, p < 0.05). PNS was weakly negatively correlated with the DLI in 3-mm area (r=-0.219, p < 0.05), and IntDen in 3-mm core area was weakly negatively correlated with the DLI in 3-mm area (r=-0.291, p < 0.05).Conclusion: A combination of iTrace, anterior segment analysis and LOCS III may be beneficial in objectively assessing the opacity of different regions of the lens.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142134891","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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Closed-loop systems: recent advancements and lived experiences. 闭环系统：最新进展和生活经验。

Expert review of medical devices Pub Date : 2024-10-01 Epub Date: 2024-10-10 DOI: 10.1080/17434440.2024.2406901

Nithya Kadiyala, Roman Hovorka, Charlotte K Boughton

{"title":"Closed-loop systems: recent advancements and lived experiences.","authors":"Nithya Kadiyala, Roman Hovorka, Charlotte K Boughton","doi":"10.1080/17434440.2024.2406901","DOIUrl":"10.1080/17434440.2024.2406901","url":null,"abstract":"Introduction: Hybrid closed loop systems are now commercially available for people with type 1 diabetes and are increasingly being adopted into clinical practice. Real-world data reflect both the glycemic and quality of life benefits reported in trials.Areas covered: In this review, we summarize the key clinical efficacy and safety evidence for hybrid closed-loop systems, and the lived experience of users with type 1 diabetes across different age groups and during pregnancy. We comment on recent and emerging advancements addressing performance limitations and user experience, as well as the use of closed-loop systems in other types of diabetes.Expert opinion: Emerging technological developments in closed-loop systems focus on improving performance and increasing automation to further optimize glycemic outcomes and improve quality of life for users. Workforce developments are now urgently required to ensure widespread equitable access to this life-changing technology. Future applications of closed-loop technology are expected to expand into other types of diabetes including type 2 diabetes.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11493052/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142402467","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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Transcranial magnetic stimulation for the rehabilitation of patients with addiction: current status and future prospects. 经颅磁刺激用于成瘾患者的康复：现状与前景。

Expert review of medical devices Pub Date : 2024-10-01 Epub Date: 2024-09-25 DOI: 10.1080/17434440.2024.2404962

Victor M Tang, Daniel M Blumberger

{"title":"Transcranial magnetic stimulation for the rehabilitation of patients with addiction: current status and future prospects.","authors":"Victor M Tang, Daniel M Blumberger","doi":"10.1080/17434440.2024.2404962","DOIUrl":"10.1080/17434440.2024.2404962","url":null,"abstract":"Introduction: Substance use disorders (SUDs) are severe conditions that remain extremely challenging to treat in clinical practice. With high rates of non-response to current treatment options and several SUDs with no approved interventions, novel therapies are needed. Repetitive transcranial magnetic stimulation (rTMS) can non-invasively modulate the neurocircuitry of brain-based disorders, and investigation into its therapeutic potential for SUDs is growing rapidly.Areas covered: In this review, we summarize the clinical research to date evaluating its safety and efficacy for various SUDs. We highlight the investigations comparing different stimulation parameters to present our current understanding on optimal stimulation parameters. Additionally, we cover key research avenues in the use of neuroimaging to guide treatment, cue-induction paradigms, and adjunctive or combination treatments that may optimize outcomes.Expert opinion: Evidence of rTMS as an effective treatment for certain SUDs has emerged and is preliminary for others. There are a growing number of studies showing benefit and meta-analyses suggesting that rTMS can significantly reduce substance craving and consumption. However, the optimal approach has not been determined, and there is a great deal of heterogeneity in rTMS protocols and mixed outcomes. Further research into strategies for enhancing precision will be crucial in moving the field forward.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142335165","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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Digital colposcopy image analysis techniques requirements and their role in clinical diagnosis: a systematic review. 数字阴道镜图像分析技术要求及其在临床诊断中的作用：系统综述。

Expert review of medical devices Pub Date : 2024-10-01 Epub Date: 2024-10-06 DOI: 10.1080/17434440.2024.2407549

Parimala Tamang, Mousumi Gupta, Annet Thatal

{"title":"Digital colposcopy image analysis techniques requirements and their role in clinical diagnosis: a systematic review.","authors":"Parimala Tamang, Mousumi Gupta, Annet Thatal","doi":"10.1080/17434440.2024.2407549","DOIUrl":"10.1080/17434440.2024.2407549","url":null,"abstract":"Introduction: Colposcopy is a medical procedure for detecting cervical lesions. Access to devices required for colposcopy procedures is limited in low- and middle-income countries. However, various existing digital imaging techniques based on artificial intelligence offer solutions to analyze colposcopy images and address accessibility challenges.Methods: We systematically searched PubMed, National Library of Medicine, and Crossref, which met our inclusion criteria for our study. Various methods and research gaps are addressed, including how variability in images and sample size affect the accuracy of the methods. The quality and risk of each study were assessed following the QUADAS-2 guidelines.Results: Development of image analysis and compression algorithms, and their efficiency are analyzed. Most of the studied algorithms have attained specificity, sensitivity, and accuracy which range from 86% to 95%, 75%-100%, and 100%, respectively, and these results were validated by the clinician to analyze the images quickly and thus minimize biases among the clinicians.Conclusion: This systematic review provides a comprehensive study on colposcopy image analysis stages and the advantages of utilizing digital imaging techniques to enhance image analysis and diagnostic procedures and ensure prompt consultations. Furthermore, compression techniques can be applied to send medical images over media for further analysis among periphery hospitals.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142383048","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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Transforming medical education: the impact of innovations in technology and medical devices. 改革医学教育：技术和医疗设备创新的影响。

Expert review of medical devices Pub Date : 2024-09-01 Epub Date: 2024-09-05 DOI: 10.1080/17434440.2024.2400153

Levent Altintas, Melike Sahiner

{"title":"Transforming medical education: the impact of innovations in technology and medical devices.","authors":"Levent Altintas, Melike Sahiner","doi":"10.1080/17434440.2024.2400153","DOIUrl":"10.1080/17434440.2024.2400153","url":null,"abstract":"Introduction: The rapid advancement of technology and the integration of innovative medical devices are significantly transforming medical education. This review examines the impact of these changes and the importance of adapting educational strategies to leverage these advancements.Areas covered: This narrative review employs a qualitative approach. From an initial pool of 294 articles, researchers conducted independent screenings and identified 134 studies relevant to innovations in technology and their impact on medical education. Following a comprehensive review and consensus, studies deemed to be of low relevance were excluded, resulting in a final selection of 74 articles. An expert panel discussion was held, and the study concludes with a final section that presents the findings and offers brief, clear recommendations.Expert opinion: This study indicates that the utilization of Innovative medical technologies has the potential to enhance learning outcomes. The use of simulations allows students to engage in hands-on practice without risking patient harm. Mobile devices afford students uninterrupted access to educational resources, thereby enabling efficient learning. Artificial intelligence (AI) has the potential to personalize education, enhance diagnostic skills, and foster critical thinking. Further research in this field has the potential to yield significant insights.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142134892","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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Medical device similarity analysis: a promising approach to medical device equivalence regulation. 医疗器械相似性分析：医疗器械等效性监管的可行方法。

Expert review of medical devices Pub Date : 2024-09-01 Epub Date: 2024-09-19 DOI: 10.1080/17434440.2024.2402027

Jan Sündermann, Joaquin Delgado Fernandez, Rupert Kellner, Theodor Doll, Ulrich P Froriep, Annette Bitsch

{"title":"Medical device similarity analysis: a promising approach to medical device equivalence regulation.","authors":"Jan Sündermann, Joaquin Delgado Fernandez, Rupert Kellner, Theodor Doll, Ulrich P Froriep, Annette Bitsch","doi":"10.1080/17434440.2024.2402027","DOIUrl":"10.1080/17434440.2024.2402027","url":null,"abstract":"Background: This study aims to facilitate the identification of similar devices for both, the European Medical Device Regulation (MDR) and the US 510(k) equivalence pathway by leveraging existing data. Both are related to the regulatory pathway of read across for chemicals, where toxicological data from a known substance is transferred to one under investigation, as they aim to streamline the accreditation process for new devices and chemicals.Research design and methods: This study employs latent semantic analysis to generate similarity values, harnessing the US Food and Drug Administration 510k-database, utilizing their 'Device Descriptions' and 'Intended Use' statements.Results: For the representative inhaler cluster, similarity values up to 0.999 were generated for devices within a 510(k)-predicate tree, whereas values up to 0.124 were gathered for devices outside this group.Conclusion: Traditionally, MDR equivalence involves manual review of many devices, which is laborious. However, our results suggest that the automated calculation of similarity coefficients streamlines this process, thus reducing regulatory effort, which can be beneficial for patients needing medical devices. Although this study is focused on the European perspective, it can find application within 510(k) equivalence regulation. The conceptual approach is reminiscent of chemical fingerprint similarity analysis employed in read-across.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142304652","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