Expert review of medical devices最新文献_第6页

Unlocking the brain's secrets: the NeuroEXPLORER revolution in PET imaging. 解开大脑的秘密：PET成像中的神经探索者革命。

IF 2.7

Expert review of medical devices Pub Date : 2025-08-01 Epub Date: 2025-06-19 DOI: 10.1080/17434440.2025.2522822

Luca Filippi, Roberta Danieli

引用次数: 0

Consumer-facing and professional medical devices in cardiology: monitoring and evaluation of big data and the implications for the practice of cardiology. 心脏病学中面向消费者和专业的医疗设备：大数据的监测和评估及其对心脏病学实践的影响。

IF 2.7

Expert review of medical devices Pub Date : 2025-08-01 Epub Date: 2025-06-03 DOI: 10.1080/17434440.2025.2514005

Sri Nuvvula, Amgad N Makaryus

{"title":"Consumer-facing and professional medical devices in cardiology: monitoring and evaluation of big data and the implications for the practice of cardiology.","authors":"Sri Nuvvula, Amgad N Makaryus","doi":"10.1080/17434440.2025.2514005","DOIUrl":"10.1080/17434440.2025.2514005","url":null,"abstract":"Introduction: With the ever-expanding increase in the availability of electronic devices that can monitor everything from a patient's daily step count to more detailed devices that can measure or estimate pulmonary artery pressures in patients with heart failure, the amount of data measured by these devices produces mountains of information.Areas covered: Our review will examine the various options and developments of both consumer-facing and professional medical devices. We discuss provider-facing cardiac devices including pacemakers, implantable cardioverter-defibrillators, Holter monitors, implantable loop recorders, left ventricular assist devices, patch monitors, and pulmonary artery pressure sensors, as well as consumer-facing cardiac medical devices including the Apple Watch and the Fitbit wearable device. We searched through the available studies on the PubMed, Cochrane Library, and Embase databases for information on these devices. The role of artificial intelligence in the analysis and interpretation of data currently and in the future is also discussed.Expert opinion: We expect future consumer-facing cardiac medical devices to focus on ventricular arrhythmias especially given their clinical impact. We also expect clinical data and patient-specific information to play a larger role as artificial intelligence advances, and it becomes more capable of drawing conclusions using multiple variables from a single patient.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"857-868"},"PeriodicalIF":2.7,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144183092","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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Differentiating between hepatocellular carcinoma and its mimickers using contrast-enhanced ultrasound with perflubutane microbubbles. 全氟丁烷微泡造影增强超声鉴别肝细胞癌及其模拟癌。

IF 2.7

Expert review of medical devices Pub Date : 2025-08-01 Epub Date: 2025-05-29 DOI: 10.1080/17434440.2025.2481223

Yasunori Minami, Katsutoshi Sugimoto, Hidekatus Kuroda, Naohisa Kamiyama, Chikara Ogawa, Masatoshi Kudo

{"title":"Differentiating between hepatocellular carcinoma and its mimickers using contrast-enhanced ultrasound with perflubutane microbubbles.","authors":"Yasunori Minami, Katsutoshi Sugimoto, Hidekatus Kuroda, Naohisa Kamiyama, Chikara Ogawa, Masatoshi Kudo","doi":"10.1080/17434440.2025.2481223","DOIUrl":"10.1080/17434440.2025.2481223","url":null,"abstract":"Introduction: Contrast-enhanced ultrasound (CEUS) is performed to non-invasively confirm a diagnosis of hepatocellular carcinoma (HCC) in high-risk patients. Typical imaging characteristics for HCC include non-rim arterial phase hyperenhancement (APHE), a washout appearance during the portal phase, and a defect in the Kupffer phase on CEUS using perflubutane microbubbles (Sonazoid). CEUS can show high diagnostic accuracy for HCC; however, we sometimes encounter challenging situations for diagnosing HCC.Areas covered: Some HCCs do not show APHE or the washout appearance, and other hepatic malignancies may exhibit similar imaging findings and be misdiagnosed as HCC. In addition, HCC needs to be differentiated from various types of hypervascular benign liver lesions. This review focuses on atypical imaging findings for HCC and typical imaging findings for common mimics of HCC as well as appropriate diagnostic workups for these lesions. Additionally, the literature review methodology, encompassing searches in PubMed, from January 1995 to January 2025, is briefly outlined.Expert opinion: Clinicians need to carefully consider the histopathological features, imaging characteristics, and differential diagnoses of hypervascular liver lesions in order to prevent a misdiagnosis and select appropriate treatment plans. A detailed understanding of typical and atypical imaging features may prevent the false-positive diagnosis of HCC.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"817-826"},"PeriodicalIF":2.7,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144176241","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

Artificial intelligence and machine learning-driven design of self-healing biomedical composites. 人工智能和机器学习驱动的自修复生物医学复合材料设计。

IF 2.7

Expert review of medical devices Pub Date : 2025-08-01 Epub Date: 2025-06-17 DOI: 10.1080/17434440.2025.2520291

Senthil Maharaj Kennedy, Amudhan K, Padmapriya K, Jeen Robert Rb

{"title":"Artificial intelligence and machine learning-driven design of self-healing biomedical composites.","authors":"Senthil Maharaj Kennedy, Amudhan K, Padmapriya K, Jeen Robert Rb","doi":"10.1080/17434440.2025.2520291","DOIUrl":"10.1080/17434440.2025.2520291","url":null,"abstract":"Introduction: The integration of Artificial Intelligence (AI) and Machine Learning (ML) has significantly enhanced the development of self-healing composites, especially in biomedical fields including tissue engineering, medication delivery, and implantable devices. These materials are designed to self-repair damage, enhancing durability, patient safety, and operational reliability. Considering that traditional materials may deteriorate under physiological conditions, intelligent self-healing composites augmented by AI/ML offer a revolutionary alternative.Areas covered: This work examines current progress in AI- and ML-facilitated design, selection, and optimization of self-healing composites for biomedical applications. Attention is directed toward the application of supervised and unsupervised learning methodologies - such as Bayesian optimization, neural networks, and support vector machines to improve healing efficiency by 30-50%, decrease formulation time by approximately 40%, and achieve predictive accuracies of over 90% regarding failure or healing behavior in specific studies.Expert opinion: The research examines ethical aspects, encompassing data protection, algorithmic transparency, and adherence to regulatory standards such as FDA and ISO 10,993. The paper emphasizes the transformational potential of AI/ML in facilitating intelligent, responsive, and patient-specific composite designs, while also addressing possible issues such as dataset bias and algorithmic opacity. The results indicate that AI-enhanced self-healing systems will be pivotal in the future of customized medicine.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"787-805"},"PeriodicalIF":2.7,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144304093","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

Deep learning without borders: recent advances in ultrasound image classification for liver diseases diagnosis. 无边界深度学习：肝脏疾病超声图像分类的最新进展。

IF 2.7

Expert review of medical devices Pub Date : 2025-08-01 Epub Date: 2025-06-09 DOI: 10.1080/17434440.2025.2514764

Midya Yousefzamani, Farshid Babapour Mofrad

{"title":"Deep learning without borders: recent advances in ultrasound image classification for liver diseases diagnosis.","authors":"Midya Yousefzamani, Farshid Babapour Mofrad","doi":"10.1080/17434440.2025.2514764","DOIUrl":"10.1080/17434440.2025.2514764","url":null,"abstract":"Introduction: Liver diseases are among the top global health burdens. Recently, there has been an increasing significance of diagnostics without discomfort to the patient; among them, ultrasound is the most used. Deep learning, in particular convolutional neural networks, has revolutionized the classification of liver diseases by automatically performing some specific analyses of difficult images.Areas covered: This review summarizes the progress that has been made in deep learning techniques for the classification of liver diseases using ultrasound imaging. It evaluates various models from CNNs to their hybrid versions, such as CNN-Transformer, for detecting fatty liver, fibrosis, and liver cancer, among others. Several challenges in the generalization of data and models across a different clinical environment are also discussed.Expert opinion: Deep learning has great prospects for automatic diagnosis of liver diseases. Most of the models have performed with high accuracy in different clinical studies. Despite this promise, challenges relating to generalization have remained. Future hardware developments and access to quality clinical data continue to further improve the performance of these models and ensure their vital role in the diagnosis of liver diseases.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"827-843"},"PeriodicalIF":2.7,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144188667","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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Response to letter to the editor on 'the potential power of Neuralink - how brain-machine interfaces can revolutionize medicine'. 回复给编辑的关于“神经连接的潜在力量——脑机接口如何彻底改变医学”的信。

IF 2.7

Expert review of medical devices Pub Date : 2025-08-01 Epub Date: 2025-06-17 DOI: 10.1080/17434440.2025.2521399

Rahul Kumar, Ethan Waisberg, Joshua Ong, Andrew G Lee

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Patient-specific plates for distal radius osteotomy: a review of the literature and a parametric plate design concept. 桡骨远端截骨的患者特异性钢板：文献回顾和参数化钢板设计概念。

IF 2.7

Expert review of medical devices Pub Date : 2025-08-01 Epub Date: 2025-06-16 DOI: 10.1080/17434440.2025.2519477

Emilia Gryska, Dimitrios Zarkadas, Charlotte Stor Swinkels, Katleen Libberecht, Anders Björkman

{"title":"Patient-specific plates for distal radius osteotomy: a review of the literature and a parametric plate design concept.","authors":"Emilia Gryska, Dimitrios Zarkadas, Charlotte Stor Swinkels, Katleen Libberecht, Anders Björkman","doi":"10.1080/17434440.2025.2519477","DOIUrl":"10.1080/17434440.2025.2519477","url":null,"abstract":"Introduction: Distal radius fractures are the most common fractures in the body. While the majority heal well, some cases result in symptomatic malunion requiring surgical correction via osteotomy. Virtual surgical planning and patient-specific surgical guides are now widely used to improve precision over traditional two-dimensional planning and freehand osteotomy. However, these procedures almost exclusively use off-the-shelf plates that may not fit a patient's anatomy well. 3D-designed patient-specific plates (PSPs) provide a precise fit, overcoming the limitations of off-the-shelf plates.Areas covered: We summarized the literature on PSPs for correcting distal radius malunion available in May 2025 using PubMed, and reference and citation screening. We discussed the outcomes, design considerations, and cost. We further proposed a parametric plate design concept. Lastly, we discussed design requirements and regulatory aspects of PSPs.Expert opinion: PSPs eliminate the need to compromise the virtual surgical plan to match the off-the-shelf plate, leading to more accurate and stable corrections. The parametric approach offers a more cost-effective alternative to designing PSPs, but further research is needed. Successful integration of parametric PSPs into clinical routine will require investments from plate manufacturers. Future studies will likely compare outcomes with off-the-shelf plates and PSPs in patients and 3D-printed bone models.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"881-888"},"PeriodicalIF":2.7,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144277051","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

Methodologies for the benefit-risk analysis of medical devices: a systematic review. 医疗器械收益-风险分析方法：系统综述。

IF 2.7

Expert review of medical devices Pub Date : 2025-08-01 Epub Date: 2025-06-15 DOI: 10.1080/17434440.2025.2517168

Oscar Freyer, Fatemeh Jahed, Max Ostermann, Mirko Feig, Stephen Gilbert

{"title":"Methodologies for the benefit-risk analysis of medical devices: a systematic review.","authors":"Oscar Freyer, Fatemeh Jahed, Max Ostermann, Mirko Feig, Stephen Gilbert","doi":"10.1080/17434440.2025.2517168","DOIUrl":"10.1080/17434440.2025.2517168","url":null,"abstract":"Introduction: The use of medical devices (MDs) carries both benefits and risks. Regulatory frameworks mandate the weighing of both through a benefit-risk analysis (BRA). This review aims to identify existing BRA methodologies and evaluate their strengths and weaknesses to evaluate their sufficiency in guiding developers and regulators.Methods: A literature search following PRISMA-S was conducted in five databases. Peer-reviewed publications were included when they described BRA methodologies for MDs. Publications on unrelated technologies, pharmaceuticals, non-English publications, and with insufficient descriptions were excluded. The methods were summarized and assessed for their degree of objectivity and for the use of numerical calculations.Results: The search identified 918 records, with 17 meeting the inclusion criteria, describing 16 methods. The methods varied in their reliance on numerical calculations and their degree of objectivity, with a significant correlation between both.Conclusion: Our findings indicate that quantitative methods involve subjective decisions, particularly in endpoint identification and relevance assignment, which means they cannot eliminate the subjectivity and bias for which qualitative methods are criticized. The findings support previous observations of ambiguity in the regulatory process, amplified by technologies with hard-to-quantify risks, and suggest that current BRA methodologies are often limited and may be insufficient to guide developers and regulators.Protocol registration: https://doi.org/10.17605/OSF.IO/RT4SV, identifier is osf.io/rt4sv.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"889-902"},"PeriodicalIF":2.7,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144259682","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

Current and future directions for the use of handheld fundus cameras in telehealth. 在远程保健中使用手持式眼底相机的当前和未来方向。

Expert review of medical devices Pub Date : 2025-07-01 Epub Date: 2025-05-30 DOI: 10.1080/17434440.2025.2508877

Sarah D Cleveland, Mikayla J Baker, Arthur G Erdman, Hossein Nazari

{"title":"Current and future directions for the use of handheld fundus cameras in telehealth.","authors":"Sarah D Cleveland, Mikayla J Baker, Arthur G Erdman, Hossein Nazari","doi":"10.1080/17434440.2025.2508877","DOIUrl":"10.1080/17434440.2025.2508877","url":null,"abstract":"Introduction: A shortage of trained retinal specialists has created a growing need for a telehealth retinal screening alternative. Recent developments in handheld fundus cameras, enhanced by artificial intelligence (AI) and machine learning (ML) methods, have created a promising avenue to satisfy the unmet need for efficient retinal disease screening. This paper discusses the state of current handheld fundus cameras as well as promising future directions.Areas covered: Commercially available handheld fundus cameras and the current and future developments in telehealth retinal screenings using these cameras are discussed. Relevant literature encompassing handheld fundus cameras, diagnostic accuracy, and AI in grading were included. Commercial handheld fundus cameras were targeted in the literature and from their company websites. Additional information was obtained through dialogs with company representatives.Expert opinion: Handheld fundus cameras utilized for telehealth retinal screening have shown success in multiple small-scale studies. To make their usage more widespread, multiple technical, technological, and methodical barriers must be addressed. This can be accomplished by improving the technology, utilizing AI, and developing telehealth guidelines.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"657-665"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144136521","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

Visual performance during night driving after intraocular refractive surgery procedures. 眼内屈光手术后夜间驾驶的视觉表现。

Expert review of medical devices Pub Date : 2025-07-01 Epub Date: 2025-05-29 DOI: 10.1080/17434440.2025.2512038

Sonia Puente-Bustillo, Alfredo Holgueras, Alberto López-Miguel, Miguel J Maldonado

{"title":"Visual performance during night driving after intraocular refractive surgery procedures.","authors":"Sonia Puente-Bustillo, Alfredo Holgueras, Alberto López-Miguel, Miguel J Maldonado","doi":"10.1080/17434440.2025.2512038","DOIUrl":"10.1080/17434440.2025.2512038","url":null,"abstract":"Introduction: Cataracts reduce visual acuity and contrast sensitivity, and increase photic phenomena, especially at night. Recent advancements in cataract surgery have improved intraocular lens (IOL) designs. Monofocal, multifocal, and extended depth-of-focus IOLs offer different vision ranges but can still cause adverse visual effects like reduced contrast sensitivity and photic phenomena, affecting night driving. Investigating how different IOLs affect night driving is crucial for road safety and quality of life.Areas covered: Studies assessing night driving performance in patients who underwent surgery with monofocal, multifocal, and extended depth-of-focus IOL implantations were included in this review. The following databases were searched to conduct the review: PubMed, Scopus and Web of Science. The level of scientific evidence was graded according to the Scottish Intercollegiate Guidelines Network (SIGN).Expert opinion: Multifocal IOL implantation improves quality of life, however night driving continues to be challenging for some multifocal IOL patients whose neuroadaptation process has not been completed. Therefore, the use of validated questionnaires to adequately assess night driving before and after IOL implantation is highly recommended. Further well-designed randomized clinical trials are needed to objectively assess visual function during night driving. Night driving simulators could provide complementary reliable information to questionnaires' outcomes.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"675-684"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144153036","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