Expert review of medical devices最新文献_第5页

Target temperature management: a review and new prospect of cooling methods and devices. 目标温度管理：冷却方法和装置的回顾与新展望。

IF 2.7

Expert review of medical devices Pub Date : 2025-09-01 Epub Date: 2025-07-23 DOI: 10.1080/17434440.2025.2537393

Yiping Wang, Yangfan Liang, Halidan Abudu, Ziying Wang, Haojun Fan, Chuanlong Li

{"title":"Target temperature management: a review and new prospect of cooling methods and devices.","authors":"Yiping Wang, Yangfan Liang, Halidan Abudu, Ziying Wang, Haojun Fan, Chuanlong Li","doi":"10.1080/17434440.2025.2537393","DOIUrl":"10.1080/17434440.2025.2537393","url":null,"abstract":"Introduction: Targeted temperature management (TTM) is a well-established neuroprotective intervention for patients following cardiac arrest (CA), ischemic stroke, traumatic brain injury, and related conditions.Areas covered: With the continued development of cooling technology, there is an increasing variety of TTM devices and cooling methods. Related application scenarios have also expanded to pre-hospital and in-hospital Settings. This paper provides a systematic review of existing TTM devices and strategies, offering a comprehensive comparative analysis of various TTM methodologies employed in cardiopulmonary resuscitation (CPR) on the basis of their underlying cooling mechanisms.Expert opinion: The paper further explores current developmental trends and ongoing controversies surrounding the implementation of TTM. TTM devices are advancing toward selective, minimally invasive, and intelligent designs. With the increasing portability and miniaturization of these devices, TTM strategies are transitioning toward phased and integrated approaches.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1009-1020"},"PeriodicalIF":2.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144692828","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 trial design in FDA submissions for neuromodulation devices, 1960-2023: a systematic review and meta-analysis. 1960-2023年FDA提交的神经调节装置临床试验设计：系统回顾和荟萃分析。

IF 2.7

Expert review of medical devices Pub Date : 2025-09-01 Epub Date: 2025-07-06 DOI: 10.1080/17434440.2025.2524450

Bassel Almarie, Kevin Pacheco-Barrios, Anna Carolyna Gianlorenco, Yasmin Eltawil, Alma Sanchez, Felipe Fregni

{"title":"Clinical trial design in FDA submissions for neuromodulation devices, 1960-2023: a systematic review and meta-analysis.","authors":"Bassel Almarie, Kevin Pacheco-Barrios, Anna Carolyna Gianlorenco, Yasmin Eltawil, Alma Sanchez, Felipe Fregni","doi":"10.1080/17434440.2025.2524450","DOIUrl":"10.1080/17434440.2025.2524450","url":null,"abstract":"Introduction: Integration of clinical trials into FDA approval processes is essential for ensuring the safety and efficacy of neuromodulation devices.Methods: From 1960 to 2023, 125 FDA-approved neuromodulation records corresponding to 109 publications (64 randomized, 45 nonrandomized trials) were identified. Regulatory records and published trial characteristics were reviewed.Results: Safety outcomes were reported in 95.4% of randomized and 82.2% of nonrandomized trials, with serious adverse events in ~ 75% of the studies. Efficacy analyses showed small Cohen's d effect sizes in 65.85% of outcomes, medium in 24.39%, and large in 9.76%, with a median NNT of 4.65. Industry funded 87.5% of randomized trials, and conflicts of interest were disclosed in 92.2% of publications. Approximately, 20% of devices were recalled - exclusively invasive. Randomized trials had larger sample sizes (median 152 subjects) than nonrandomized studies (median 53; p < 0.001), and study duration varied significantly by indication (p < 0.001).Conclusions: Our findings reveal considerable heterogeneity in the evidence supporting neuromodulation devices, with trials showing systematic safety documentation but modest efficacy. Industry-funded trials dominate the evidence base, with recalls primarily limited to invasive technologies. Evidence gaps persist in minority representation and longitudinal data.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1027-1050"},"PeriodicalIF":2.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144340779","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 of transcranial pulse stimulation: innovations in neuromodulation. 经颅脉冲刺激：神经调节的创新。

IF 2.7

Expert review of medical devices Pub Date : 2025-09-01 Epub Date: 2025-07-09 DOI: 10.1080/17434440.2025.2530119

Sze Ting Joanna Ngan, Pak Wing Calvin Cheng

{"title":"A review of transcranial pulse stimulation: innovations in neuromodulation.","authors":"Sze Ting Joanna Ngan, Pak Wing Calvin Cheng","doi":"10.1080/17434440.2025.2530119","DOIUrl":"10.1080/17434440.2025.2530119","url":null,"abstract":"Introduction: Non-invasive brain stimulations (NIBS), such as transcranial magnetic stimulation, transcranial direct current stimulation, transcranial alternating current stimulation, transcranial focused ultrasound, and transcranial pulse stimulation (TPS), employ electric currents or acoustic waves to induce and modulate neuroplasticity in humans. Thus, NIBS have the capacity to modify pathological plasticity while promoting plasticity in neuropsychiatric disorders, helping to ameliorate symptoms and enhance rehabilitation.Areas covered: The efficacy of TPS in treating neuropsychiatric disorders is still unknown; hence, this article reviews the currently available clinical studies on the therapeutic effectiveness of TPS on symptom reduction in the clinical population to inform future neuropsychiatric treatments and research directions.Expert opinion: The emerging NIBS treatment modality TPS demonstrates promising evidence in modulating symptoms in clinical population of neurocognitive disorders, common mental disorders, and neurodevelopmental disorders. It has been well tolerated across age groups, from adolescents to older adults. Thus, it is essential to encourage future research to investigate the underlying neurophysiological and biochemical effects of TPS, as well as its sustainability, by incorporating high-quality randomized controlled trials with larger sample sizes to strengthen the validation of its effects.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"979-988"},"PeriodicalIF":2.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144556205","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

Liver metastases in breast cancer: [¹⁸F]FDG and radioembolization as strategies for diagnosis and treatment. 乳腺癌肝转移：[18F]FDG和放射栓塞作为诊断和治疗策略。

IF 2.7

Expert review of medical devices Pub Date : 2025-09-01 Epub Date: 2025-06-30 DOI: 10.1080/17434440.2025.2526682

Priscilla Guglielmo, Michela Olivieri, Luca Filippi, Katia Marzo, Jelena Jandric, Marcello Rodari, Manuela Marenco, Laura Evangelista

{"title":"Liver metastases in breast cancer: [18F]FDG and radioembolization as strategies for diagnosis and treatment.","authors":"Priscilla Guglielmo, Michela Olivieri, Luca Filippi, Katia Marzo, Jelena Jandric, Marcello Rodari, Manuela Marenco, Laura Evangelista","doi":"10.1080/17434440.2025.2526682","DOIUrl":"10.1080/17434440.2025.2526682","url":null,"abstract":"Introduction: This review aims to analyze the role of [18F]FDG PET/CT and transarterial radioembolization (TARE) in managing liver metastases (LM) in breast cancer (BC), from metabolic characterization to treatment, to assess their impact on patient outcomes.Areas covered: A systematic search in PubMed and Embase (up to October 2024) identified studies on [18F]FDG PET imaging for LM in BC. Filters excluded reviews, case reports, and abstracts. Twenty-seven papers were selected, 19 were relative to the accuracy of [18F]FDG PET/CT and 8 to TARE. [18F]FDG PET/CT detected distant metastases in 10-100% of cases and LM in 0.3-38%. In most studies, PET/CT outperformed ceCT in detecting LM, though one study reported higher detection with ceCT (30.3% vs. 21.1%). The overall response rate to TARE was superior to 60%, while the overall survival ranged from 6.1 to 35.4 months, with minor severe adverse events.Expert opinion: [18F]FDG PET/CT has a high accuracy in LM detection, and TARE has a high therapeutic potential in metastatic BC. Indeed, the optimization of imaging and personalized treatment strategies may enhance patient outcomes, also by considering the future perspectives.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"999-1008"},"PeriodicalIF":2.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144531944","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

Magnetic resonance-guided ultrasound thalamotomy for essential tremor: a review. 磁共振引导下的超声丘脑切开术治疗特发性震颤：综述。

IF 2.7

Expert review of medical devices Pub Date : 2025-09-01 Epub Date: 2025-07-11 DOI: 10.1080/17434440.2025.2530765

Emmanuel De Schlichting, Ying Meng, Yuexi Huang, Ryan M Jones, Kullervo Hynynen, Clément Hamani, Agessandro Abrahao, Benjamin Davidson, Nir Lipsman

{"title":"Magnetic resonance-guided ultrasound thalamotomy for essential tremor: a review.","authors":"Emmanuel De Schlichting, Ying Meng, Yuexi Huang, Ryan M Jones, Kullervo Hynynen, Clément Hamani, Agessandro Abrahao, Benjamin Davidson, Nir Lipsman","doi":"10.1080/17434440.2025.2530765","DOIUrl":"10.1080/17434440.2025.2530765","url":null,"abstract":"Introduction: Essential tremor (ET) is a common neurological disorder characterized by involuntary, rhythmic shaking, primarily of the hands. While not life-threatening, ET significantly impairs quality of life. Pharmacological treatments, like beta-blockers or anticonvulsants, often have limited efficacy, leading patients to more aggressive alternatives such as surgical intervention. Recently, magnetic resonance-guided focused ultrasound has emerged as an alternative to surgical procedures, offering incisionless lesioning of the thalamus, resulting in immediate and sustained tremor reduction.Areas covered: This review explores the MRgFUS technique in the treatment of ET, reviewing clinical efficacy, safety, and procedural advances. A literature search was conducted using PubMed for articles published between January 2015 and March 2024, with the terms: 'MRgFUS,' 'essential tremor,' 'focused ultrasound thalamotomy,' and 'bilateral thalamotomy.' Key points such as patient selection, skull density ratio, monitoring, thermal effects and tractography are discussed.Expert opinion: MRgFUS has transformed the treatment of ET by providing a precise, incisionless alternative now included in clinical guidelines. Challenges such as SDR limitations or restricted approved-indications limit its extended use. Advances in targeting, thermometry and other biological effects such as histotripsy could expand accessibility and indications. By 2035, MRgFUS could become a standard outpatient procedure for ET and other brain disorders.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"989-997"},"PeriodicalIF":2.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144577418","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

Letter to the editor on 'the potential power of neuralink - how brain-machine interfaces can revolutionize medicine'. 给编辑的关于“神经连接的潜在力量——脑机接口如何革新医学”的信。

IF 2.7

Expert review of medical devices Pub Date : 2025-08-01 Epub Date: 2025-06-17 DOI: 10.1080/17434440.2025.2521393

Dalmacito A Cordero

引用次数: 0

Integration of artificial intelligence into cardiac ultrasonography practice. 将人工智能融入心脏超声检查实践。

IF 2.7

Expert review of medical devices Pub Date : 2025-08-01 Epub Date: 2025-06-11 DOI: 10.1080/17434440.2025.2517171

Shlomo Y Shaulian, Dhir Gala, Amgad N Makaryus

{"title":"Integration of artificial intelligence into cardiac ultrasonography practice.","authors":"Shlomo Y Shaulian, Dhir Gala, Amgad N Makaryus","doi":"10.1080/17434440.2025.2517171","DOIUrl":"10.1080/17434440.2025.2517171","url":null,"abstract":"Introduction: Over the last several decades, echocardiography has made numerous technological advancements, with one of the most significant being the integration of artificial intelligence (AI). AI algorithms assist novice operators to acquire diagnostic-quality images and automate complex analyses.Areas covered: This review explores the integration of AI into various echocardiographic modalities, including transthoracic, transesophageal, intracardiac, and point-of-care ultrasound. It examines how AI enhances image acquisition, streamlines analysis, and improves diagnostic performance across routine, critical care, and complex cardiac imaging. To conduct this review, PubMed was searched using targeted keywords aligned with each section of the paper, focusing primarily on peer-reviewed articles published from 2020 onward. Earlier studies were included when found to be foundational or frequently cited. The findings were organized thematically to highlight clinical relevance and practical applications.Expert opinion: Challenges persist in clinical application, including algorithmic bias, ethical concerns, and the need for clinician training and AI oversight. Despite these, AI's potential to revolutionize cardiovascular care through precision and accessibility remains unparalleled, with benefits likely to far outweigh obstacles if appropriately applied and implemented in cardiac ultrasonography.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"869-879"},"PeriodicalIF":2.7,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144251514","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

Device profile of the iTind temporary implantable nitinol device for benign prostatic hyperplasia. 用于良性前列腺增生的iTind临时植入式镍钛诺装置的装置简介。

IF 2.7

Expert review of medical devices Pub Date : 2025-08-01 Epub Date: 2025-06-10 DOI: 10.1080/17434440.2025.2517173

Levi Godard, Hersh Trivedi, Gopal Narang, Connor M Forbes

引用次数: 0

Diagnostic value of 24-hour Holter monitoring and conventional electrocardiogram in arrhythmia. 24小时动态心电图与常规心电图对心律失常的诊断价值。

IF 2.7

Expert review of medical devices Pub Date : 2025-08-01 Epub Date: 2025-06-04 DOI: 10.1080/17434440.2025.2514008

Juan Liu, Yang Li, Yuzhan Wang

{"title":"Diagnostic value of 24-hour Holter monitoring and conventional electrocardiogram in arrhythmia.","authors":"Juan Liu, Yang Li, Yuzhan Wang","doi":"10.1080/17434440.2025.2514008","DOIUrl":"10.1080/17434440.2025.2514008","url":null,"abstract":"Objective: This paper aims to compare the diagnostic value of 24-hour Holter monitoring and conventional electrocardiogram (ECG) in arrhythmia.Methods: The diagnostic results of 24-hour Holter monitoring and conventional ECG for these patients were compared. The diagnostic efficacy, including sensitivity, specificity, and accuracy, of the two types of ECGs was compared. Additionally, the detection rates of ventricular premature contractions in bigeminy and trigeminy, paired ventricular premature contractions, atrial premature contractions in bigeminy and trigeminy, paired atrial premature contractions, and atrioventricular conduction block by both methods were compared. Patient satisfaction with the diagnostic results of two methods was also compared.Results: Compared to the conventional ECG, 24-hour Holter monitoring exhibited higher sensitivity, specificity, and accuracy; higher detection rates of ventricular premature contractions in bigeminy and trigeminy, paired ventricular premature contractions, atrial premature contractions in bigeminy and trigeminy, paired atrial premature contractions, and atrioventricular conduction block; higher patient satisfaction.Conclusion: The 24-hour Holter monitoring demonstrates superior sensitivity, specificity, accuracy, and detection rate in diagnosing arrhythmia compared to conventional ECG. Additionally, it offers higher patient satisfaction, making it more valuable for clinical application.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"903-907"},"PeriodicalIF":2.7,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144176239","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

Functional electrical stimulation as a tool to restore motor control after spinal cord injury: translation to clinical practice. 功能性电刺激作为恢复脊髓损伤后运动控制的工具：转化为临床实践。

IF 2.7

Expert review of medical devices Pub Date : 2025-08-01 Epub Date: 2025-06-10 DOI: 10.1080/17434440.2025.2517169

Kristin E Musselman, Hope Jervis-Rademeyer, Elina Nezon

{"title":"Functional electrical stimulation as a tool to restore motor control after spinal cord injury: translation to clinical practice.","authors":"Kristin E Musselman, Hope Jervis-Rademeyer, Elina Nezon","doi":"10.1080/17434440.2025.2517169","DOIUrl":"10.1080/17434440.2025.2517169","url":null,"abstract":"Introduction: Functional electrical stimulation (FES) is a therapeutic tool that may augment motor recovery after spinal cord injury/disease (SCI). It involves applying an electrical current to muscles and/or peripheral nerves to facilitate functional movements, such as walking and reaching. Despite the potential therapeutic benefits of FES, and the considerable investment into its research and development, FES is not widely used in clinical practice.Areas covered: In this narrative review, we examine this research-to-practice gap. PubMed and Google Scholar were searched using keywords related to the population, constructs and context of interest. We provide an orientation to SCI and summarize how FES may facilitate motor recovery. Using the Knowledge-to-Action Framework as a guide, we demonstrate how co-design and implementation strategies can be incorporated into FES device development and research to aid clinical translation in SCI rehabilitation. Based on prior literature, we provide recommendations for researchers and technology developers: 1) collaborate with implementation scientists, 2) adopt participatory methods, 3) use a knowledge translation framework as a guide, 4) thoroughly understand implementation barriers and facilitators, and 5) budget time for implementation.Expert opinion: Greater focus on clinical implementation is needed in the FES research field to address the current research-to-practice gap.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"845-856"},"PeriodicalIF":2.7,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144228056","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