Expert review of medical devices最新文献_第4页

How can we improve patient access to LVAD therapy? 我们如何改善患者获得LVAD治疗的机会？

IF 2.7

Expert review of medical devices Pub Date : 2025-09-11 DOI: 10.1080/17434440.2025.2560666

Chonyang Albert, Jagpreet S Grewal, Maya Guglin

引用次数: 0

Retrograde cerebral perfusion to support aortic arch repair. 逆行脑灌注支持主动脉弓修复。

IF 2.7

Expert review of medical devices Pub Date : 2025-09-07 DOI: 10.1080/17434440.2025.2558203

Matti Jubouri, Mohamad Bashir, Mohammed Idhrees, Bashi Velayudhan, Ian M Williams, Damian M Bailey

{"title":"Retrograde cerebral perfusion to support aortic arch repair.","authors":"Matti Jubouri, Mohamad Bashir, Mohammed Idhrees, Bashi Velayudhan, Ian M Williams, Damian M Bailey","doi":"10.1080/17434440.2025.2558203","DOIUrl":"10.1080/17434440.2025.2558203","url":null,"abstract":"Introduction: Acute type A aortic dissection (ATAAD) and aortic arch aneurysms are life-threatening conditions requiring complex surgical intervention, often involving circulatory arrest. Cerebral ischemia and neurological complications remain significant challenges in aortic arch surgery. This narrative review focuses on retrograde cerebral perfusion (RCP) techniques used to mitigate these risks.Areas covered: This review article examines the evolution of cerebral protection strategies, with a focus on the techniques, parameters, and monitoring of RCP. It also compares RCP with antegrade cerebral perfusion (ACP) and deep hypothermic circulatory arrest (DHCA) regarding clinical outcomes.Expert opinion: RCP has proven to be a valuable adjunct to DHCA in aortic arch surgery, offering comparable outcomes to ACP and demonstrating superiority over DHCA alone. Precise management of venous pressure and flow rate during RCP, along with meticulous cerebral monitoring, is crucial for optimizing neurological protection. Although ACP is increasingly favored in clinical practice, RCP continues to be a safe and effective cerebral protection strategy.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-9"},"PeriodicalIF":2.7,"publicationDate":"2025-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145006911","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

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。

IF 2.7

Expert review of medical devices Pub Date : 2025-09-01 Epub 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":"925-937"},"PeriodicalIF":2.7,"publicationDate":"2025-09-01","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

Advantages of three-photon live imaging for deep tissue analysis. 三光子实时成像在深部组织分析中的优势。

IF 2.7

Expert review of medical devices Pub Date : 2025-09-01 Epub Date: 2025-06-27 DOI: 10.1080/17434440.2025.2525497

Mary Ann Go, Mengke Yang, Simon R Schultz

{"title":"Advantages of three-photon live imaging for deep tissue analysis.","authors":"Mary Ann Go, Mengke Yang, Simon R Schultz","doi":"10.1080/17434440.2025.2525497","DOIUrl":"10.1080/17434440.2025.2525497","url":null,"abstract":"Introduction: Three-photon microscopy is an emerging tool for deep tissue imaging with superior spatial resolution. It enables imaging of portions of tissue beyond the typical depth limit of two-photon microscopy.Areas covered: In this review, we give an overview of widely used deep tissue imaging modalities. We highlight the advantages of three-photon microscopy and review its current applications in biomedical research as well as its potential pre-clinical and clinical applications. Finally, we assess the challenges in the widespread use of three-photon live imaging in biomedical research and in clinical translation.Expert opinion: Three-photon microscopy holds great promise as a biomedical research tool. It can uncover insights into the structure and function of tissues beyond what is accessible with two-photon microscopy. It also has promise to be a powerful clinical tool. Future clinical applications include optical biopsies with near instantaneous results and guided surgical resections. A multimodal strategy that combines three-photon technology with a large field of view, low resolution technique may be used to overcome the limited field of view of three-photon microscopy for macroscopic tissue assessment.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"913-917"},"PeriodicalIF":2.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144487493","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。

IF 2.7

Expert review of medical devices Pub Date : 2025-09-01 Epub 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":"1021-1026"},"PeriodicalIF":2.7,"publicationDate":"2025-09-01","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

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。

IF 2.7

Expert review of medical devices Pub Date : 2025-09-01 Epub Date: 2025-06-09 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":"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":"949-965"},"PeriodicalIF":2.7,"publicationDate":"2025-09-01","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

Tumor treating fields for glioblastoma: opportunities and drawbacks. 胶质母细胞瘤的肿瘤治疗领域：机遇与缺点。

IF 2.7

Expert review of medical devices Pub Date : 2025-09-01 Epub Date: 2025-06-29 DOI: 10.1080/17434440.2025.2526679

Alessandro Pesce, Mauro Palmieri, Alessandro Frati, Antonio Santoro, Maurizio Salvati

引用次数: 0

Devices for non-fragmented removal of thrombus via mechanical grip: a patent review. 通过机械夹具非碎片清除血栓的装置：专利审查。

IF 2.7

Expert review of medical devices Pub Date : 2025-09-01 Epub Date: 2025-08-13 DOI: 10.1080/17434440.2025.2539269

Łucja Aleksandra Żurawska, Frank Gijsen, Pieter Jan van Doormaal, Paul Breedveld

{"title":"Devices for non-fragmented removal of thrombus via mechanical grip: a patent review.","authors":"Łucja Aleksandra Żurawska, Frank Gijsen, Pieter Jan van Doormaal, Paul Breedveld","doi":"10.1080/17434440.2025.2539269","DOIUrl":"10.1080/17434440.2025.2539269","url":null,"abstract":"Introduction: Thromboembolic conditions are a leading global cause of mortality and a major cause of disability. Throughout the years mechanical thrombectomy has become a preferred method of treatment. Removing thrombus in its entirety on first pass decreases procedure time as well as lowers the risk of distal embolization.Areas covered: This review provides a comprehensive overview and classification of the patent literature on devices for non-fragmented thrombus removal via grip. Patentscope database was used to search for internationally granted patents published any time before the access date (October 2024). The search using keywords and patent classification code led to identifying 141 relevant patents that were then categorized based on location and type of grip they describe.Expert opinion: The designs found are analyzed in the discussion and a broader context for their relevance is given in the expert opinion section. The following review can provide insight into possible mechanical thrombectomy methods, general trends in the field as well as serve as an inspiration in development of novel devices.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"967-977"},"PeriodicalIF":2.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144818902","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。

IF 2.7

Expert review of medical devices Pub Date : 2025-09-01 Epub Date: 2025-07-12 DOI: 10.1080/17434440.2025.2530771

Mark Schweitzer

引用次数: 0

Photic phenomena after presbyopia-correcting intraocular lens implantation: incidence, risk factors, prevention, and strategies. 矫正老花眼人工晶体植入术后的光现象：发生率、危险因素、预防和策略。

IF 2.7

Expert review of medical devices Pub Date : 2025-09-01 Epub Date: 2025-08-03 DOI: 10.1080/17434440.2025.2539262

Wenqian Shen, Baoxian Zhuo, Lei Cai, Jin Yang

{"title":"Photic phenomena after presbyopia-correcting intraocular lens implantation: incidence, risk factors, prevention, and strategies.","authors":"Wenqian Shen, Baoxian Zhuo, Lei Cai, Jin Yang","doi":"10.1080/17434440.2025.2539262","DOIUrl":"10.1080/17434440.2025.2539262","url":null,"abstract":"Introduction: The advent of refractive cataract surgery has resulted in better spectacle independence and quality of life in patients, accompanied by increased patient expectations. Photic phenomena, such as glare, halo, and starbursts, are the most common visual complaints in patients and have become major causes of dissatisfaction after refractive cataract surgery.Areas covered: Our review aimed to explore the incidence, risk factors, prevention, and management strategies for photic phenomena after presbyopia-correcting intraocular lens implantation, providing evidence to develop strategies to prevent and treat photic phenomena. The following databases were searched PubMed, Embase, and Web of Science to conduct the review. The level of scientific evidence was graded according to the Scottish Intercollegiate Guidelines Network (SIGN).Expert opinion: Photic phenomena remain a significant challenge in refractive cataract surgery, despite advancements in presbyopia-correcting intraocular lens technology. Based on current evidence, rigorous patient selection, precise surgical execution, and tailored postoperative care - is paramount to minimizing photic phenomena. Surgeons must balance technological innovation with individualized patient counseling to align expectations with achievable visual outcomes. Future well-designed studies and advanced simulation tools are needed to better assess these symptoms, explore related risk factors, and improve prevention strategies.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"939-948"},"PeriodicalIF":2.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144755498","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