Expert review of medical devices最新文献

Legal and regulatory challenges in multi-country data-driven projects developing and validating medical AI systems in the EU. 在欧盟开发和验证医疗人工智能系统的多国数据驱动项目中的法律和监管挑战。

Expert review of medical devices Pub Date : 2025-07-16 DOI: 10.1080/17434440.2025.2531295

Emilia Niemiec, Timo Minssen, Patrick A Boland, Philip D McEntee, Ronan A Cahill

{"title":"Legal and regulatory challenges in multi-country data-driven projects developing and validating medical AI systems in the EU.","authors":"Emilia Niemiec, Timo Minssen, Patrick A Boland, Philip D McEntee, Ronan A Cahill","doi":"10.1080/17434440.2025.2531295","DOIUrl":"10.1080/17434440.2025.2531295","url":null,"abstract":"Introduction: Many legal and regulatory requirements need to be considered in projects developing medical AI systems. Their implementation may be challenging as both AI technology and some of the regulations are new.Areas covered: This article examines the key legal challenges arising from the EU General Data Protection Regulation, Medical Devices Regulations, AI Act, as well as selected intellectual property issues in multi-partner projects developing medical AI systems, using an ongoing clinical validation study of such a device as a real-world exemplar.Expert opinion: The current regulatory landscape for medical AI system validation in Europe is complex, evolving, and presents some conflicting principles. Key areas that need to be addressed in future soft law instruments include data anonymization and interplay between the Medical Devices Regulation, AI Act, and General Data Protection Regulation. Policymakers should invest in regulatory science to ensure that regulatory frameworks are evidence-based and prioritize patient safety while fostering innovation.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-13"},"PeriodicalIF":0.0,"publicationDate":"2025-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144585962","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

Changes in radiological imaging: an interview with Mark Schweitzer. 放射成像的变化：马克·施韦策的访谈。

Expert review of medical devices Pub Date : 2025-07-12 DOI: 10.1080/17434440.2025.2530771

Mark Schweitzer

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。

Expert review of medical devices Pub 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":"1-9"},"PeriodicalIF":0.0,"publicationDate":"2025-07-11","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

A review of transcranial pulse stimulation: innovations in neuromodulation. 经颅脉冲刺激：神经调节的创新。

Expert review of medical devices Pub 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":"1-10"},"PeriodicalIF":0.0,"publicationDate":"2025-07-09","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

Key safety considerations for MRI examination of patients with an orthopaedic implant. 骨科植入物患者MRI检查的关键安全考虑。

Expert review of medical devices Pub Date : 2025-07-08 DOI: 10.1080/17434440.2025.2529337

Kevin M Koch, Hollis G Potter

{"title":"Key safety considerations for MRI examination of patients with an orthopaedic implant.","authors":"Kevin M Koch, Hollis G Potter","doi":"10.1080/17434440.2025.2529337","DOIUrl":"10.1080/17434440.2025.2529337","url":null,"abstract":"Introduction: Magnetic resonance imaging (MRI) provides superior soft tissue contrast, multiplanar capabilities, and avoids ionizing radiation, making it valuable for evaluating orthopedic conditions. Despite persistent concerns regarding MRI safety with orthopedic instrumentation, this imaging modality is particularly well-suited to evaluate pain and weakness following hardware placement. This review examines the evidence regarding safety and efficacy of MRI in patients with orthopedic implants.Areas covered: This review covers potential safety risks including device displacement and thermal energy deposition during MRI examinations, artifact reduction techniques such as multispectral imaging, and clinical applications in diagnosing complications surrounding orthopedic hardware. Evidence demonstrates MRI's utility in detecting adverse local tissue reactions, periprosthetic infections, implant loosening, and soft tissue complications following joint arthroplasty.Expert opinion: Based on extensive clinical experience with thousands of patients, MRI is both safe and diagnostically valuable for monitoring patients with orthopedic hardware. Modern orthopedic implants almost exclusively use non-ferromagnetic materials, eliminating displacement risks. While RF-induced heating requires consideration, no confirmed reports exist of tissue damage from MRI-induced thermal deposition near orthopedic devices. MRI serves as a particularly valuable screening tool for identifying early-stage soft tissue reactions and osteolysis, especially critical in scenarios where proactive monitoring can significantly improve outcomes.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-6"},"PeriodicalIF":0.0,"publicationDate":"2025-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144546568","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。

Expert review of medical devices Pub 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":"1-24"},"PeriodicalIF":0.0,"publicationDate":"2025-07-06","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

RETRACTED ARTICLE : Comparison of supraglottic airway device vs. endotracheal intubation for initial airway management in out-of-hospital cardiac arrest: a systematic review and meta-analysis. 院外心脏骤停初始气道管理中声门上气道装置与气管内插管的比较：一项系统回顾和荟萃分析。

Expert review of medical devices Pub Date : 2025-07-01 DOI: 10.1080/17434440.2024.2446384

Yan Tao, Juxia Zhang, Lei Feng

{"title":"RETRACTED ARTICLE : Comparison of supraglottic airway device vs. endotracheal intubation for initial airway management in out-of-hospital cardiac arrest: a systematic review and meta-analysis.","authors":"Yan Tao, Juxia Zhang, Lei Feng","doi":"10.1080/17434440.2024.2446384","DOIUrl":"10.1080/17434440.2024.2446384","url":null,"abstract":"Introduction: Out-of-hospital cardiac arrest (OHCA) is characterized by the cessation of mechanical cardiac activity and voluntary circulation occurring outside of a hospital setting, making it the leading cause of death worldwide. Recently, the optimal approach to airway management has been a subject of controversy.Methods: Follow PRISMA guidelines for systematic evaluation and meta-analysis. The primary outcome was survival assessed by four measures: Restoration of spontaneous circulation, survival to hospital or emergency department, evaluation of functional recovery after PCR (measured at both discharge and 3 months after PCR), and neurological function score at discharge.Results: A total of six RCTs (14,205 patients) were included in the systematic review, and four RCTs (13,053 patients) were included in the meta-analysis. Five studies (83.3%) of RCTs with ETI controls were notable for their high quality, with low risk of bias judged in all 7 domains of the risk assessment scale. Showed an advantage of SGA (compared to ETI) with potential for ROSC (95% CI [1.02 to 1.18], I2 = 48%, p = 0.01) and survival to hospital or emergency department (95% CI [1.01 to 1.17], I2 = 12%, p = 0.02).Conclusions: This systematic review and meta-analysis found a significant association between SGA and the possibility of obtaining ROSC and reaching the hospital or emergency department after CPR in OHCA.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"i-ix"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142883760","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

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 : 2025-07-01 Epub Date: 2025-06-15 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":"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":"685-698"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","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