Expert review of medical devices最新文献_第7页

Single-pulse transcranial magnetic stimulation for assessment of motor development in infants with early brain injury. 单脉冲经颅磁刺激用于评估早期脑损伤婴儿的运动发育。

Expert review of medical devices Pub Date : 2024-03-01 Epub Date: 2024-01-03 DOI: 10.1080/17434440.2023.2299310

Ellen N Sutter, Cameron P Casey, Bernadette T Gillick

{"title":"Single-pulse transcranial magnetic stimulation for assessment of motor development in infants with early brain injury.","authors":"Ellen N Sutter, Cameron P Casey, Bernadette T Gillick","doi":"10.1080/17434440.2023.2299310","DOIUrl":"10.1080/17434440.2023.2299310","url":null,"abstract":"Introduction: Single-pulse transcranial magnetic stimulation (TMS) has many applications for pediatric clinical populations, including infants with perinatal brain injury. As a noninvasive neuromodulation tool, single-pulse TMS has been used safely in infants and children to assess corticospinal integrity and circuitry patterns. TMS may have important applications in early detection of atypical motor development or cerebral palsy.Areas covered: The authors identified and summarized relevant studies incorporating TMS in infants, including findings related to corticospinal development and circuitry, motor cortex localization and mapping, and safety. This special report also describes methodologies and safety considerations related to TMS assessment in infants, and discusses potential applications related to diagnosis of cerebral palsy and early intervention.Expert opinion: Single-pulse TMS has demonstrated safety and feasibility in infants with perinatal brain injury and may provide insight into neuromotor development and potential cerebral palsy diagnosis. Additional research in larger sample sizes will more fully evaluate the utility of TMS biomarkers in early diagnosis and intervention. Methodological challenges to performing TMS in infants and technical/equipment limitations require additional consideration and innovation toward clinical implementation. Future research may explore use of noninvasive neuromodulation techniques as an intervention in younger children with perinatal brain injury to improve motor outcomes.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10947901/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139081178","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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Hydrophilic biomaterial intravenous hydrogel catheter for complication reduction in PICC and midline catheters. 用于减少 PICC 和中线导管并发症的亲水性生物材料静脉注射水凝胶导管。

Expert review of medical devices Pub Date : 2024-03-01 Epub Date: 2024-03-06 DOI: 10.1080/17434440.2024.2324885

Nancy Moureau

{"title":"Hydrophilic biomaterial intravenous hydrogel catheter for complication reduction in PICC and midline catheters.","authors":"Nancy Moureau","doi":"10.1080/17434440.2024.2324885","DOIUrl":"10.1080/17434440.2024.2324885","url":null,"abstract":"Introduction: More than 30% of peripherally inserted central catheters (PICCs) and midline catheters experience complications. Most complications are related to thrombotic cellular adherence to catheter materials.Areas covered: This manuscript outlines PICC and midline catheter complications, the need to reduce complications and how hydrogel catheters may provide a solution to address these unmet needs based on available evidence.Expert opinion: Patients commonly require PICC or midline catheters for treatment to establish a reliable form of intravenous access. Catheters, while reliable in most cases, are not without complications, including occlusion, thrombosis and infection, each related to cellular adherence to the catheter material. Hydrophilic catheter coatings and composites have been developed to mitigate these thrombotic complications, reduce adherence of blood and bacterial cells to catheters and provide greater patient safety with these devices. Hydrogel materials are highly biocompatible and have been effective in reducing cellular adherence and the formation of biofilms on surfaces. Smooth hydrophilic catheter surfaces are potentially more comfortable for the patient, with reduced friction during insertion and removal. A catheter constructed of hydrophilic biomaterial, a hydrogel composite material, may minimize thrombotic complications in PICC and midline catheters, improving catheter performance and outcomes for patients.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140041185","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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Towards an evaluation framework for medical device-integrated electronic medical record. 医疗设备集成电子病历的评估框架。

Expert review of medical devices Pub Date : 2024-03-01 Epub Date: 2024-02-13 DOI: 10.1080/17434440.2024.2315024

Aeshah Alhammad, Maryati Mohd Yusof, Dian Indrayani Jambari

{"title":"Towards an evaluation framework for medical device-integrated electronic medical record.","authors":"Aeshah Alhammad, Maryati Mohd Yusof, Dian Indrayani Jambari","doi":"10.1080/17434440.2024.2315024","DOIUrl":"10.1080/17434440.2024.2315024","url":null,"abstract":"Introduction: Medical device (MD)-integrated (I) electronic medical record (EMR) (MDI-EMR) poses cyber threats that undermine patient safety, and thus, they require effective control mechanisms. We reviewed the related literature, including existing EMR and MD risk assessment approaches, to identify MDI-EMR comprehensive evaluation dimensions and measures.Areas covered: We searched multiple databases, including PubMed, Web of Knowledge, Scopus, ACM, Embase, IEEE and Ingenta. We explored various evaluation aspects of MD and EMR to gain a better understanding of their complex integration. We reviewed numerous risk management and assessment frameworks related to MD and EMR security aspects and mitigation controls and then identified their common evaluation aspects. Our review indicated that previous evaluation frameworks assessed MD and EMR independently. To address this gap, we proposed an evaluation framework based on the sociotechnical dimensions of health information systems and risk assessment approaches for MDs to evaluate MDI-EMR integratively.Expert opinion: The emergence of MDI-EMR cyber threats requires appropriate evaluation tools to ensure the safe development and application of MDI-EMR. Consequently, our proposed framework will continue to evolve through subsequent validations and refinements. This process aims to establish its applicability in informing stakeholders of the safety level and assessing its effectiveness in mitigating risks for future improvements.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139693719","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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Correction. 更正。

Expert review of medical devices Pub Date : 2024-01-10 DOI: 10.1080/17434440.2023.2300226

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Wearable devices for gait and posture monitoring via telemedicine in people with movement disorders and multiple sclerosis: a systematic review. 通过远程医疗监测运动障碍和多发性硬化症患者步态和姿势的可穿戴设备：系统综述。

Expert review of medical devices Pub Date : 2024-01-01 Epub Date: 2024-02-04 DOI: 10.1080/17434440.2023.2298342

Francesca Salaorni, Giulia Bonardi, Federico Schena, Michele Tinazzi, Marialuisa Gandolfi

{"title":"Wearable devices for gait and posture monitoring via telemedicine in people with movement disorders and multiple sclerosis: a systematic review.","authors":"Francesca Salaorni, Giulia Bonardi, Federico Schena, Michele Tinazzi, Marialuisa Gandolfi","doi":"10.1080/17434440.2023.2298342","DOIUrl":"10.1080/17434440.2023.2298342","url":null,"abstract":"Introduction: Wearable devices and telemedicine are increasingly used to track health-related parameters across patient populations. Since gait and postural control deficits contribute to mobility deficits in persons with movement disorders and multiple sclerosis, we thought it interesting to evaluate devices in telemedicine for gait and posture monitoring in such patients.Methods: For this systematic review, we searched the electronic databases MEDLINE (PubMed), SCOPUS, Cochrane Library, and SPORTDiscus. Of the 452 records retrieved, 12 met the inclusion/exclusion criteria. Data about (1) study characteristics and clinical aspects, (2) technical, and (3) telemonitoring and teleconsulting were retrieved, The studies were quality assessed.Results: All studies involved patients with Parkinson's disease; most used triaxial accelerometers for general assessment (n = 4), assessment of motor fluctuation (n = 3), falls (n = 2), and turning (n = 3). Sensor placement and count varied widely across studies. Nine used lab-validated algorithms for data analysis. Only one discussed synchronous patient feedback and asynchronous teleconsultation.Conclusions: Wearable devices enable real-world patient monitoring and suggest biomarkers for symptoms and behaviors related to underlying gait disorders. thus enriching clinical assessment and personalized treatment plans. As digital healthcare evolves, further research is needed to enhance device accuracy, assess user acceptability, and integrate these tools into telemedicine infrastructure.Prospero registration: CRD42022355460.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138833699","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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The current use of tissue expanders in breast reconstruction: device design, features, and technical considerations. 组织扩张器在乳房重建中的当前应用:设备设计、特点和技术考虑。

Expert review of medical devices Pub Date : 2024-01-01 Epub Date: 2024-02-04 DOI: 10.1080/17434440.2023.2288911

Min-Jeong Cho, Rana V Farhadi, David W Nash, Joseph Kaleeny, Stephen P Povoski, Albert H Chao

{"title":"The current use of tissue expanders in breast reconstruction: device design, features, and technical considerations.","authors":"Min-Jeong Cho, Rana V Farhadi, David W Nash, Joseph Kaleeny, Stephen P Povoski, Albert H Chao","doi":"10.1080/17434440.2023.2288911","DOIUrl":"10.1080/17434440.2023.2288911","url":null,"abstract":"Introduction: The use of tissue expanders (TE) in post-mastectomy breast reconstruction is a widely accepted practice, especially in patients desiring implant-based breast reconstruction. It has become the standard of care to perform a two-staged breast reconstruction using tissue expanders for the past 50 years due to its reliability, safety, cost-effectiveness, and versatility. Due to its popularity, there are numerous types and features of breast tissue expanders and various surgical approaches available for plastic surgeons.Areas covered: In this article, we will review the role of tissue expanders in breast reconstruction, the types and features of breast tissue expanders, and technical considerations.Expert opinion: The use of tissue expanders in breast reconstruction offers significant advantages of preserving the breast skin envelope and reestablishing the breast mound. With evolving approaches to breast reconstruction, tissue expander design, and application underwent several refinements and modifications. Due to these advances, studies on its long-term efficacy and safety profile typically fall behind and more studies with higher levels of evidence are needed to better evaluate the efficacy and safety profile of tissue expanders. With increased understanding, reconstructive surgeons can minimize complications and maximize reconstructive, aesthetic outcomes with high patient satisfaction.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138465157","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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Assessment of the carpal tunnel and associated neural structures with superb microvascular imaging: a scoping review. 评价腕管及相关神经结构与精湛的微血管成像:一个范围审查。

Expert review of medical devices Pub Date : 2024-01-01 Epub Date: 2024-02-04 DOI: 10.1080/17434440.2023.2285856

Ting-Yu Lin, Peng-Chieh Shen, Ke-Vin Chang, Wei-Ting Wu, Levent Özçakar

{"title":"Assessment of the carpal tunnel and associated neural structures with superb microvascular imaging: a scoping review.","authors":"Ting-Yu Lin, Peng-Chieh Shen, Ke-Vin Chang, Wei-Ting Wu, Levent Özçakar","doi":"10.1080/17434440.2023.2285856","DOIUrl":"10.1080/17434440.2023.2285856","url":null,"abstract":"Introduction: Superb microvascular imaging (SMI) is an advanced ultrasound technique that portrays microcirculation. Its clinical applications have been studied in various diseases, including carpal tunnel syndrome (CTS) i.e. the most common entrapment neuropathy. This scoping review explores the role of SMI in diagnosing CTS or the assessment of relevant neural structures.Methods: We conducted a comprehensive search of electronic databases (PubMed, Embase and Web of Science) up to 26 September 2023. Two independent authors conducted the literature search, quality assessment, and data extraction.Results: This review includes seven studies comprising 385 wrists. SMI consistently revealed increased intraneural vascularity in the median nerves of patients with CTS compared to healthy individuals. While SMI demonstrated higher sensitivity than traditional Doppler methods for detecting CTS, its specificity was somewhat lower. Combining SMI with B-mode ultrasound appears to enhance the diagnostic accuracy for CTS. However, the relationship between SMI findings and CTS severity remains unclear.Conclusions: This review highlighted the ability of SMI to provide detailed vascular structures in both healthy wrists and those with CTS. Additional research is crucial to determine the typical SMI findings of the carpal tunnel and within that context, tailor more precise diagnostic/therapeutic applications for the CTS population.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136400811","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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Technology assistance in primary total knee replacement: hype or hope? 初级全膝关节置换术的技术援助:炒作还是希望?

Expert review of medical devices Pub Date : 2024-01-01 Epub Date: 2024-02-04 DOI: 10.1080/17434440.2023.2287576

Bart G Pijls

{"title":"Technology assistance in primary total knee replacement: hype or hope?","authors":"Bart G Pijls","doi":"10.1080/17434440.2023.2287576","DOIUrl":"10.1080/17434440.2023.2287576","url":null,"abstract":"Introduction: Total knee replacement (TKR) reduces pain, it increases quality of life and it generally lasts a long time with revision rates of less than 5% at 10 years. Some authors have suggested that outcomes may be further improved by technology assistance.Areas covered: Technology assistance in primary TKR includes technologies such as navigated TKR, patient specific instrumentation TKR and robotic TKR.Expert opinion: In general, technology assistance results in higher accuracy of component positioning and alignment, but this is likely not clinically relevant as no clinically important difference in clinical outcomes, quality of life and complications such as revisions has been demonstrated in meta-analyses of randomized controlled trials. As technology assistance in primary TKR is increasingly used to capture patient and surgeon data, surgeons have an increasingly important role in protecting their patients' data and their own data. Real world evidence of implant registries has shown that TKR without technologically assistance can achieve perfectly acceptable outcomes. Although there is a genuine hope that technology-assisted TKR may further improve these outcomes, this hope is based on promises rather than solid evidence. At the same time, technology assisted TKR is heavily promoted including direct patient marketing, which are aspects of a hype.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138296840","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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Transcatheter aortic valve durability, predictors of bioprosthetic valve dysfunction, longer-term outcomes - a review. 经导管主动脉瓣耐久性，生物瓣膜功能障碍的预测因素，长期结果综述。

Expert review of medical devices Pub Date : 2024-01-01 Epub Date: 2024-02-04 DOI: 10.1080/17434440.2023.2288275

Abigail Johanna Šolc, Hana Línková, Petr Toušek

{"title":"Transcatheter aortic valve durability, predictors of bioprosthetic valve dysfunction, longer-term outcomes - a review.","authors":"Abigail Johanna Šolc, Hana Línková, Petr Toušek","doi":"10.1080/17434440.2023.2288275","DOIUrl":"10.1080/17434440.2023.2288275","url":null,"abstract":"Introduction: Transcatheter aortic valve implantation (TAVI) is one of the most significant inventions in cardiology, as it provides a viable minimally invasive treatment option for patients with aortic stenosis, the most common valvular disease in the developed world and one with a poor prognosis when left untreated. Using data available to date, this review aims to discuss and identify possible predictors of TAVI valve durability - an essential requirement for the device's wide-spread use, especially in younger patients.Areas covered: This article explores the main causes of bioprosthetic valve dysfunction (BVD) based on pathophysiology and available data, and reviews possible predictors of BVD including prosthesis-related, procedure-related, and patient-related factors. An emphasis is made on affectable predictors, which could potentially be targeted with prevention management and improve valve durability. A literature search of online medical databases was conducted using relevant key words and dates; significant clinical trials were identified. A brief overview of important randomized controlled trials with mid to long-term follow-up is included in this article.Expert opinion: Identifying modifiable predictors of valve dysfunction presents an opportunity to enhance and predict valve durability - a necessity as patients with longer life-expectancies are being considered for the procedure.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138465158","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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Devices for osteoarthritis symptoms treatment: a patent review. 骨关节炎症状治疗设备：专利回顾。

Expert review of medical devices Pub Date : 2024-01-01 Epub Date: 2024-02-04 DOI: 10.1080/17434440.2023.2298729

Mariana Mendonça Santos, Anamaria Mendonça Santos, José Adão Carvalho Nascimento, Cláudio Carvalho Santana, Ana Maria Santos Oliveira, Silvia Vitoria Silva Cezar, Alcimary Bispo Santos, Luiza Abrahão Frank, Mairim Russo Serafini

{"title":"Devices for osteoarthritis symptoms treatment: a patent review.","authors":"Mariana Mendonça Santos, Anamaria Mendonça Santos, José Adão Carvalho Nascimento, Cláudio Carvalho Santana, Ana Maria Santos Oliveira, Silvia Vitoria Silva Cezar, Alcimary Bispo Santos, Luiza Abrahão Frank, Mairim Russo Serafini","doi":"10.1080/17434440.2023.2298729","DOIUrl":"10.1080/17434440.2023.2298729","url":null,"abstract":"Introduction: Osteoarthritis is a musculoskeletal disease that can lead to the loss and inability of those affected to perform normal daily functions, which leads to a decrease in quality of life. The main symptoms of osteoarthritis are tenderness, joint pain, stiffness, crepitus, limited movement, and local inflammation.Areas covered: The selected patents were deposited from 2010 to April 2022 involving 57 documents that were in line with the study objective in the final selection. The patents were classified in years, country, and applicants. Also, the therapeutic fields that presented the most documents were electrical stimulation, phototherapy, and ultrasound, followed by magnetic, electromagnetic, and thermotherapy. Therefore, the most current therapies used in the documents are already on the market.Expert opinion: Although the OA is cureless, non-surgical treatments are classified as the primary management approach for this disease. The pharmacological and non-pharmacological therapies are employed to reduce its prevalence and ensure the effectiveness of treatments. A strategy for relieving OA symptoms is non-pharmacological treatment, which can be based on exercise and patient education, combined with other alternative therapies. These therapies are used as supplements to the main OA treatments, enhancing the effectiveness of treatment outcomes.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139379033","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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