Expert review of medical devices最新文献_第3页

Revolutionizing breast cancer care: the synergy of AI-powered diagnostics, haptic-based biopsy simulators, and advanced surgical techniques. 革新乳腺癌护理：人工智能诊断、基于触觉的活检模拟器和先进手术技术的协同作用。

Expert review of medical devices Pub Date : 2025-05-29 DOI: 10.1080/17434440.2025.2514007

Tanyaradzwa Roselyn Tichiwangana, Qianwen Ji, Xingqi Fan, Tao Ying, Xiaojun Chen

{"title":"Revolutionizing breast cancer care: the synergy of AI-powered diagnostics, haptic-based biopsy simulators, and advanced surgical techniques.","authors":"Tanyaradzwa Roselyn Tichiwangana, Qianwen Ji, Xingqi Fan, Tao Ying, Xiaojun Chen","doi":"10.1080/17434440.2025.2514007","DOIUrl":"https://doi.org/10.1080/17434440.2025.2514007","url":null,"abstract":"Background: In 2022, a report by the World Health Organization revealed 2.3 million new breast cancer cases and 670,000 related deaths, which represented 11.7% of all cancer cases worldwide. Early screening and biopsy for breast cancer can provide more effective and minimally invasive treatment options. As treatment options evolve, breast cancer surgery can ensure cure rate and aesthetics after surgery.Areas covered: This review article examines the latest advancements in breast cancer care, highlighting the integration of artificial intelligence (AI) in diagnostics, the development of haptic-based breast biopsy simulators, and innovative surgical techniques.Expert opinion: AI-driven diagnostic systems have significantly improved the accuracy and effectiveness of breast cancer screening with a precision comparable to that of experienced radiologists. Furthermore, haptic-based breast biopsy simulators are revolutionizing surgical training by providing practitioners with a realistic and safe environment to refine their biopsy techniques and breast surgery skills. Concurrently, advancements in surgical procedures, often augmented by AI and virtual reality (VR) simulations, are transforming breast cancer treatment, which facilitate the practice of complex surgical techniques, potentially resulting in more specialized and minimally invasive procedures. Collectively, these innovations are improving the screening, diagnosis, and surgical results for breast cancer patients.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144182383","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 clinical data and regulatory submission characteristics for neuromodulation devices approved via the 510(k) pathway (1996-2024). 通过510(k)途径批准的神经调节装置的临床数据和监管提交特征评估（1996-2024）。

Expert review of medical devices Pub Date : 2025-05-29 DOI: 10.1080/17434440.2025.2508869

Bassel Almarie, Felipe Fregni

{"title":"Evaluation of clinical data and regulatory submission characteristics for neuromodulation devices approved via the 510(k) pathway (1996-2024).","authors":"Bassel Almarie, Felipe Fregni","doi":"10.1080/17434440.2025.2508869","DOIUrl":"10.1080/17434440.2025.2508869","url":null,"abstract":"Objectives: The 510(k) pathway is prevalent for medical device approval, yet its integration of clinical data, especially in neuromodulation devices, remains underexplored.Methods: We evaluated neuromodulation devices approved via the 510(k) pathway from 1996 to 2024. Using Natural Language Processing, we traced predicate networks and analyzed clinical data inclusion. Published clinical data were also reviewed.Results: Among 715 medical devices, 31 neuromodulation devices were identified, with 30 having summary documents. The predicate network included 160-related 510(k) approvals; 48 devices (30%) included clinical data, mainly from randomized trials. Nearly 30% of files were untraceable or lacked an FDA summary. Most approvals were based on a single predicate. Seven percent were subject to recalls, all approved without clinical data. Median time-to-approval was significantly longer for devices with clinical data than those without (157 vs. 110 days, p = 0.008). Clinical data from 36 publications included 32 trials and 4 observational studies, with a median Cohen's d of 0.83 (0.27-1.71) and NNT of 4.8 (2.4-7.9). Trials with differing indications from predicates had larger sample sizes.Conclusions: A significant shift toward clinical data inclusion in the 510(k) pathway was observed, particularly for neuromodulation devices. Challenges include balancing safety standards while streamlining approval process.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-8"},"PeriodicalIF":0.0,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144153027","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

Four-step formula for the Siewert classification of adenocarcinomas of the esophagogastric junction: a computed tomography-based quantitative model. 食管胃交界腺癌Siewert分型的四步公式：基于计算机断层扫描的定量模型。

Expert review of medical devices Pub Date : 2025-05-29 DOI: 10.1080/17434440.2025.2510534

Yi-Ting Liu, Yong-Ai Li, Jia-Zheng Li, Yin-Kui Wang, Zi-Fan Chen, Wan-Ying Ji, Qin Feng, Shuang-Xi Li, Xiao-Ting Li, Fang-Jing Hou, Zhao-Bo Zhang, Kan Xue, Fei Shan, Lei Tang, Zi-Yu Li

{"title":"Four-step formula for the Siewert classification of adenocarcinomas of the esophagogastric junction: a computed tomography-based quantitative model.","authors":"Yi-Ting Liu, Yong-Ai Li, Jia-Zheng Li, Yin-Kui Wang, Zi-Fan Chen, Wan-Ying Ji, Qin Feng, Shuang-Xi Li, Xiao-Ting Li, Fang-Jing Hou, Zhao-Bo Zhang, Kan Xue, Fei Shan, Lei Tang, Zi-Yu Li","doi":"10.1080/17434440.2025.2510534","DOIUrl":"https://doi.org/10.1080/17434440.2025.2510534","url":null,"abstract":"Objective: This study aimed to develop a novel quantitative methodology to classify the Siewert type on multiplanar reconstructed (MPR) computed tomography (CT) and subsequently guide the diagnosis of adenocarcinoma of the oesophagogastric junction.Methods: Patients in the retrospective development cohort and prospective validation cohort 1 were recruited from Peking University Hospital. Patients in prospective validation cohort 2 were recruited from Changzhi People's Hospital. A streamlined method was designed to determine the slice numbers for the oesophagogastric junction (EGJ) and tumor center by combining axial and coronal CT images; these key slice positions were then used to formulate a system for the Siewert classification. The CT-based four-step formula for Siewert type (CT-FSFS) consists of the following: STEP 1: determining the axial level of the EGJ; STEP 2: distinguishing Siewert Type III from Siewert Type I/II; STEP 3: predicting the misclassification of Siewert Type III as Siewert Type II; STEP 4: correcting the misclassification of Siewert Type III as Siewert Type II using the deflection angle. Results: The CT-FSFS method demonstrated robust accuracy across all three cohorts: 89.5% in the development cohort, 91.0% in validation cohort 1 and 89.7% in validation cohort 2. In differentiating Type I/II from Type III, the formula demonstrated high specificity (96.9%) and positive predictive value (97.1%) in the development cohort. Conclusions: This study presents a reproducible, quantitative method for classifying the Siewert type using MPR CT images and, for the first time, defines the normal size range. The proposed methodology may serve as a valuable tool for preoperative surgical planning.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144176198","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

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。

Expert review of medical devices Pub Date : 2025-05-28 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":"https://doi.org/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":""},"PeriodicalIF":0.0,"publicationDate":"2025-05-28","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

A comprehensive overview of real-world evidence in medical device approvals in the United States. 在美国医疗器械批准的真实世界证据的全面概述。

Expert review of medical devices Pub Date : 2025-05-28 DOI: 10.1080/17434440.2025.2512041

Swarnali Goswami, Prajakta P Masurkar, Aashrey Kaul

{"title":"A comprehensive overview of real-world evidence in medical device approvals in the United States.","authors":"Swarnali Goswami, Prajakta P Masurkar, Aashrey Kaul","doi":"10.1080/17434440.2025.2512041","DOIUrl":"10.1080/17434440.2025.2512041","url":null,"abstract":"Background: Despite the U.S. Food and Drug Administration (FDA)'s recognition of the value of real-world evidence (RWE) in the evaluation of medical devices, there is a lack of consensus among RWE stakeholders regarding the FDA's specific evidentiary requirements.Research design and methods: This paper reviews the publicly accessible FDA approval documents from January 2020 to July 2024 and describes the intended purpose of RWE incorporated into medical device approvals, i.e. to support claims of safety and/or effectiveness and its impact on the FDA's benefit-risk assessment.Results: Between January 2020 and July 2024, 117 medical devices included RWE in their submissions. Of these, 74 (63.25%) used RWE to support approval, while in 43 (36.75%) submissions, an RWE study was requested by the FDA. The most common submission types were 510(k) and Pre-Market Approval (PMA)-Panel Track (27.4%), followed by PMA-Original (21.9%) and De Novo (19.48%). RWE most frequently supported effectiveness (85.24%), safety (72.97%). Cardiovascular devices accounted for 44% of approvals incorporating RWE, with registry-based studies being the most common data source.Conclusions: This review highlights key areas of FDA feedback on RWE studies, including concerns related to methodology and data quality emphasizing the need for careful selection of real-world data and rigorous study design.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-7"},"PeriodicalIF":0.0,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144164168","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

Robotic assistance in total knee arthroplasty surgery: necessity or trend? 全膝关节置换术中机器人辅助：必要性还是趋势？

Expert review of medical devices Pub Date : 2025-05-27 DOI: 10.1080/17434440.2025.2512042

Vicente J León-Muñoz, Joaquín Moya-Angeler

引用次数: 0

Home detection of atrial fibrillation using cardiac activity analysis: technologies available to the patient. 心房颤动的家庭检测使用心脏活动分析：技术提供给病人。

Expert review of medical devices Pub Date : 2025-05-26 DOI: 10.1080/17434440.2025.2510537

Federica Ricci, Eugenio Mattei, Giovanni Calcagnini, Federica Censi

{"title":"Home detection of atrial fibrillation using cardiac activity analysis: technologies available to the patient.","authors":"Federica Ricci, Eugenio Mattei, Giovanni Calcagnini, Federica Censi","doi":"10.1080/17434440.2025.2510537","DOIUrl":"10.1080/17434440.2025.2510537","url":null,"abstract":"Introduction: Atrial fibrillation (AF) is the most common cardiac arrhythmia, whose incidence and prevalence have increased over the last 20 years and will continue to increase over the next 30 years. It is characterized by irregular atrial activation, leading to complications as stroke and heart failure. Due to its intermittent and asymptomatic nature, diagnosing and monitoring AF is challenging but crucial for effective treatment and prevention of serious complications.Areas covered: This study reviews noninvasive medical devices available for home detection of AF by analyzing cardiac activity through ECG or photoplethysmography (PPG). The review covers the technologies underlying single-lead ECG acquisition and PPG sensors, and describes how these are used, also in combination, in home-use medical devices (including smartwatches and wristbands).Expert opinion: Single-lead ECG and PPG technologies in consumer electronics have revolutionized AF detection, making it more accessible and convenient for patients. Despite some limitations in signal quality and diagnostic scope, these devices offer significant benefits for early AF detection and management. The use of wearable devices, including smartwatches and wristbands, for heart activity monitoring represents a promising advancement in patient-lead healthcare, potentially leading to better outcomes through timely medical intervention and improved patient engagement in managing their condition.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-14"},"PeriodicalIF":0.0,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144136525","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-based solutions supporting patients with swallowing problems. 基于设备的解决方案支持吞咽问题的患者。

Expert review of medical devices Pub Date : 2025-05-25 DOI: 10.1080/17434440.2025.2508452

Ayodele Sasegbon, Ivy Cheng, Meng Dai, Wanqi Li, Shaheen Hamdy

{"title":"Device-based solutions supporting patients with swallowing problems.","authors":"Ayodele Sasegbon, Ivy Cheng, Meng Dai, Wanqi Li, Shaheen Hamdy","doi":"10.1080/17434440.2025.2508452","DOIUrl":"10.1080/17434440.2025.2508452","url":null,"abstract":"Introduction: Swallowing is a highly complex activity requiring the coordination of numerous muscles within the head and neck through connections from multiple areas within the central nervous system. Dysphagia is common and has long been known to lead to significant adverse effects on morbidity, mortality, and quality of life. Classical approaches toward dysphagia management involve input by clinical deglutologists who teach rehabilitative exercises and recommend alteration of the consistency of food and fluids. However, the evidence base in support of some of these approaches is inconsistent and requires further and larger studies to support their widespread implementation.Areas covered: This paper shall explore some of these novel techniques and explore the evidence that they will alter the future of dysphagia care.Expert opinion: Medical devices form one aspect of these rehabilitation strategies, and over the past decade, numerous novel techniques targeting the complex swallowing sensorimotor pathway or swallowing associated musculature have come to prominence. These include interventions such as noninvasive brain stimulation, swallowing related biofeedback, and peripheral stimulation approaches, developed to bolster existing management methods. The evidence suggests that many of these approaches have the capability to enhance swallowing function and impact dysphagia recovery, however, more evidence is needed.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-11"},"PeriodicalIF":0.0,"publicationDate":"2025-05-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144096500","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

Indications and outcomes of revision total ankle arthroplasty. 改良全踝关节置换术的适应症和结果。

Expert review of medical devices Pub Date : 2025-05-23 DOI: 10.1080/17434440.2025.2509770

Kevin A Wu, Albert T Anastasio, Joshua A Wu, Julia Ralph, Crystal Jing, Alexandra N Krez, James K DeOrio

{"title":"Indications and outcomes of revision total ankle arthroplasty.","authors":"Kevin A Wu, Albert T Anastasio, Joshua A Wu, Julia Ralph, Crystal Jing, Alexandra N Krez, James K DeOrio","doi":"10.1080/17434440.2025.2509770","DOIUrl":"10.1080/17434440.2025.2509770","url":null,"abstract":"Introduction: Total ankle arthroplasty (TAA) has emerged as an alternative to ankle arthrodesis for managing end-stage ankle arthritis. However, the long-term survival of TAA remains inferior to that of hip and knee replacements, leading to a higher rate of revision TAA. Understanding the indications and outcomes of revision procedures is critical for orthopedic surgeons managing complex ankle pathology.Areas covered: This review explores the indications, surgical considerations, and outcomes associated with revision TAA. A structured literature search was conducted using PubMed and Scopus (January 2000-March 2024) with keywords including 'revision total ankle arthroplasty,' 'implant failure,' 'complications,' and 'biologic augmentation.'Expert opinion: Revision TAA presents unique surgical and biomechanical challenges that require individualized treatment approaches. While it offers pain relief and functional restoration for select patients, outcomes remain less favorable compared to primary TAA. Future advancements in implant technology may improve long-term success rates. Additionally, optimizing patient selection criteria and perioperative protocols will be essential to reducing complications and enhancing outcomes. Further research is needed to refine revision techniques and establish guidelines for managing failed TAA effectively.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-13"},"PeriodicalIF":0.0,"publicationDate":"2025-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144112910","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

Minimally invasive and robotic techniques for implantation of ventricular assist devices in patients with heart failure. 心力衰竭患者心室辅助装置植入的微创和机器人技术。

Expert review of medical devices Pub Date : 2025-05-22 DOI: 10.1080/17434440.2025.2505672

Nicholas R Hess, Martin Winter, Andrea Amabile, Faaz Ashraf, David J Kaczorowski, Johannes Bonatti

{"title":"Minimally invasive and robotic techniques for implantation of ventricular assist devices in patients with heart failure.","authors":"Nicholas R Hess, Martin Winter, Andrea Amabile, Faaz Ashraf, David J Kaczorowski, Johannes Bonatti","doi":"10.1080/17434440.2025.2505672","DOIUrl":"https://doi.org/10.1080/17434440.2025.2505672","url":null,"abstract":"Introduction: Minimally invasive approaches to cardiac surgery have been developing over the last several decades, including less invasive strategies to implantation of durable left ventricular assist devices (LVAD). Less invasive approaches to LVAD insertion aim to reduce surgical trauma and promote shorter hospital stay and recovery times; and for those bridged to heart transplantation, they aim to facilitate later reentry.Areas covered: PubMed was searched from 1980 to present to identify existing literature regarding non-sternotomy approaches to LVAD insertion. This review outlines the history and early attempts of sternal sparing LVAD insertion, commonly utilized surgical approaches in contemporary practice, as well as the experience with concomitant procedures using these approaches. Additionally, a summary of postoperative outcomes described in the literature is provided. Lastly, this review describes the early use of robotic assistance in durable LVAD implantation.Expert opinion: Sternal sparing approaches to LVAD insertion are feasible, safe, and in multiple experiences, have been shown to reduce operative and postoperative blood loss, reoperation, right ventricular dysfunction, and hospital length of stay. The use of surgical robotics in LVAD implantation remains at its infancy but poses a promising avenue to a totally endoscopic approach to durable mechanical assist therapy.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144121799","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