Expert review of medical devices最新文献_第9页

Letter to editor regarding "Emerging monitoring techniques in oral appliance therapy for sleep apnea: a narrative review with a focus on mandibular jaw movement analysis". 致编辑关于“睡眠呼吸暂停口腔器械治疗中新兴监测技术：以下颌运动分析为重点的叙述性回顾”的信。

IF 2.7

Expert review of medical devices Pub Date : 2026-05-01 Epub Date: 2026-03-04 DOI: 10.1080/17434440.2026.2640191

Jiayi Chen

引用次数: 0

Incidence of hospital revisits and shoulder-related outcomes between two orthopedic sutures used for rotator cuff repair: what does the real-world evidence tell us? 两种用于肩袖修复的骨科缝合线之间的医院复诊发生率和肩部相关结果：现实世界的证据告诉我们什么？

IF 2.7

Expert review of medical devices Pub Date : 2026-05-01 Epub Date: 2026-03-05 DOI: 10.1080/17434440.2026.2639576

Grant E Garrigues, Katherine A Corso, Jill W Ruppenkamp, Caroline E Smith, Jenny R Pahys

{"title":"Incidence of hospital revisits and shoulder-related outcomes between two orthopedic sutures used for rotator cuff repair: what does the real-world evidence tell us?","authors":"Grant E Garrigues, Katherine A Corso, Jill W Ruppenkamp, Caroline E Smith, Jenny R Pahys","doi":"10.1080/17434440.2026.2639576","DOIUrl":"10.1080/17434440.2026.2639576","url":null,"abstract":"Background: Rotator cuff tears cause burdensome pain impacting patients' daily use of their shoulder. We evaluated the outcomes after rotator cuff repair (RCR) utilizing two different high-tensile sutures.Methods: A comparative study using a hospital dataset evaluated a novel high-tensile contractile suture, Dynacord, or a high-tensile non-contractile (NC) suture, FiberWire. The primary outcome was one-year all-cause hospital revisits. Secondary outcomes were shoulder-related hospital revisits and revisions defined as tendon transfer, RCR, or reverse shoulder arthroplasty. Propensity score weighting was applied, and generalized linear models were used to analyze all outcomes.Results: The cumulative incidence of one-year all-cause hospital revisits was significantly lower for the novel vs. the NC suture (32.5% vs. 37.0%; p-value: <0.001). The incidence of shoulder-related revisits was 10.6% vs. 13.9% and revision surgery overall was 1.4% vs. 1.4%; and for each revision surgery type, RCR was 1.3% vs. 1.1%, tendon transfer was 0.06% vs. 0.1%, and rTSA was 0.1% vs. 0.4%.Conclusions: Compared to the NC suture, use of the novel suture was associated with a significantly lower rate of all-cause hospital revisits within 1 year postoperatively, and a lower shoulder-related revisit rate. However, no difference was observed between groups in the overall revision surgery rate.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"547-555"},"PeriodicalIF":2.7,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147328623","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

The impact of integrating artificial intelligence into regulatory affairs functions in the Medtech industry. 将人工智能整合到医疗技术行业的监管事务功能中的影响。

IF 2.7

Expert review of medical devices Pub Date : 2026-05-01 Epub Date: 2026-04-16 DOI: 10.1080/17434440.2026.2648001

Renee Cotta, Mary Garvey, Olivia McDermott

{"title":"The impact of integrating artificial intelligence into regulatory affairs functions in the Medtech industry.","authors":"Renee Cotta, Mary Garvey, Olivia McDermott","doi":"10.1080/17434440.2026.2648001","DOIUrl":"10.1080/17434440.2026.2648001","url":null,"abstract":"Introduction: Artificial intelligence is becoming an important tool in the medical technology industry where its implementation has the potential to streamline processes and provide rapid and efficient data analysis and interpretation in the regulatory affairs function.Areas covered: The adoption of Artificial Intelligence is emerging as a tool in the MedTech Regulatory Affairs function and the success factors and barriers to successful implementation are outlined. Empirical case applications and hands-on experiences of artificial intelligence are limiting factors in the adoption of AI. The factors for successful adoption include rigorous validation processes aligned with trustworthiness, transparency, and reproducibility. In addition, effective regulatory guidance and internal governance are required. Literature from the last two decades from 2016 to 2026 in relation to the above was reviewed from the Web of Science, SCOPUS, and MEDLINE academic databases.Expert opinion: Currently, persistent barriers to artificial intelligence adoption are global acceptance by regulatory bodies for artificial intelligence-generated outputs, assuring compliance with the quality and interoperability of data across jurisdictions, data hallucinations, cost, training, and integration hinder the application of artificial intelligence. Cross-regional policy harmonization is an opportunity for the regulators as adoption broadens.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"509-518"},"PeriodicalIF":2.7,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147679681","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

Advances and existing challenges facing implants in the treatment of osteochondral defects: a narrative review of the current literature. 植入物治疗骨软骨缺损的进展和面临的挑战：当前文献的叙述性回顾。

IF 2.7

Expert review of medical devices Pub Date : 2026-05-01 Epub Date: 2026-03-28 DOI: 10.1080/17434440.2026.2648741

Gregorio Alberto, Carlotta Franceschi, Yazan Abu Salem, Pietro Conte, Giuseppe Anzillotti, Berardo Di Matteo, Marina Lipina, Alexey Lychagin, Eugene Kalinsky, Daniele D'Arrigo, Elizaveta Kon

{"title":"Advances and existing challenges facing implants in the treatment of osteochondral defects: a narrative review of the current literature.","authors":"Gregorio Alberto, Carlotta Franceschi, Yazan Abu Salem, Pietro Conte, Giuseppe Anzillotti, Berardo Di Matteo, Marina Lipina, Alexey Lychagin, Eugene Kalinsky, Daniele D'Arrigo, Elizaveta Kon","doi":"10.1080/17434440.2026.2648741","DOIUrl":"10.1080/17434440.2026.2648741","url":null,"abstract":"Introduction: Focal osteochondral defects of the knee represent a significant clinical challenge due to pain, functional impairment, and the risk of early osteoarthritis. Conventional cartilage repair techniques may provide satisfactory results in selected patients but are often limited by donor-site morbidity, multistage procedures, and inconsistent long-term outcomes. Recent advances in biomaterials and tissue engineering have led to the development of osteochondral implants designed to restore the entire osteochondral unit and improve functional recovery.Areas covered: This narrative review summarizes the current literature on the most widely investigated osteochondral implants for the treatment of focal knee defects, including AMIC with Chondro-Gide, MaioRegen, Agili-C, and focal metal resurfacing implants. The available clinical evidence was analyzed with particular attention to implant design, surgical indications, clinical outcomes, and complications. In addition, recent technological developments and the main challenges affecting implant integration and durability were examined.Expert opinion: From an expert perspective, current implants show encouraging short- and mid-term clinical outcomes, but none has yet emerged as the standard of care. Future research should focus on long-term comparative studies, improved patient-selection strategies, and technological innovations aimed at optimizing osteointegration, durability, and defect-specific treatment.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"519-532"},"PeriodicalIF":2.7,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147489060","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

The need for materiovigilance in leprosy-treating hospitals in India: a critical perspective on patient safety. 印度麻风治疗医院物质警戒的必要性：从病人安全的关键角度看问题。

IF 2.7

Expert review of medical devices Pub Date : 2026-05-01 Epub Date: 2026-03-02 DOI: 10.1080/17434440.2026.2638364

Thangaraju Pugazhenthan, Sanjeev Khanth Pe, Arokiaraj U, Naveen V

{"title":"The need for materiovigilance in leprosy-treating hospitals in India: a critical perspective on patient safety.","authors":"Thangaraju Pugazhenthan, Sanjeev Khanth Pe, Arokiaraj U, Naveen V","doi":"10.1080/17434440.2026.2638364","DOIUrl":"10.1080/17434440.2026.2638364","url":null,"abstract":"Introduction: Leprosy remains a major public health challenge in countries like India, Brazil, and Indonesia. The materiovigilance program was established to monitor the safety of medical devices and helps to protect health-care workers and patients from device-related injuries. Leprosy patients suffer from sensory loss and are at high risk of developing injuries with medical devices. Therefore, integrating materiovigilance program with the national leprosy care program is essential to improve the safety and wellbeing of leprosy patients.Areas covered: This critical perspective covers the role of materiovigilance in India, the classification of medical devices based on their risk status, devices used in leprosy management, the Indian and international target goals for leprosy elimination, and emphasis on the integration of materiovigilance programs with leprosy programs in leprosy treating hospitals.Expert opinion: There is a significant gap existing in the leprosy elimination policies regarding the safety concerns with the use of medical devices. Successful integration of materiovigilance framework with leprosy elimination policies will influence the treatment outcomes in a positive manner. The key challenges to overcome are lack of awareness, training, and funding. Implementing the integration strategy in a stage-wise manner will help to identify the lacunae, operational issues, and further strengthen the program.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"475-479"},"PeriodicalIF":2.7,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147286694","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

Multimodal magnetic resonance imaging outcomes of transcranial direct current stimulation in psychiatric and neurological disorders: a systematic review. 多模态磁共振成像结果经颅直流电刺激精神和神经疾病：系统回顾。

IF 2.7

Expert review of medical devices Pub Date : 2026-05-01 Epub Date: 2026-03-18 DOI: 10.1080/17434440.2026.2641166

Mariana Pita, Pedro H R Silva, Beatriz Cavendish, Tamires Zanão, Lais B Razza, Andre R Brunoni

{"title":"Multimodal magnetic resonance imaging outcomes of transcranial direct current stimulation in psychiatric and neurological disorders: a systematic review.","authors":"Mariana Pita, Pedro H R Silva, Beatriz Cavendish, Tamires Zanão, Lais B Razza, Andre R Brunoni","doi":"10.1080/17434440.2026.2641166","DOIUrl":"10.1080/17434440.2026.2641166","url":null,"abstract":"Introduction: Transcranial direct current stimulation (tDCS) is a promising neuromodulation technique for psychiatric and neurological disorders, but its clinical efficacy is heterogeneous. Magnetic resonance imaging (MRI) can be used to identify response predictors and understand underlying mechanisms.Methods: A systematic review was conducted (PubMed/Web of Science/Embase) from inception to May 2025. Nineteen randomized clinical trials (RCTs) were included, using MRI methods to investigate tDCS effects for major depressive disorder (MDD), schizophrenia, alcohol use disorder (AUD), stroke, epilepsy, and fibromyalgia.Results: Outcomes focused on pre and post effects (n = 9), baseline MRI-based predictors (n = 7), or both (n = 3). Quality assessment showed that most studies (68.4%) had a low risk of bias. Functional MRI was the most frequent modality, followed by structural MRI. Besides methodological differences, findings were heterogeneous. Although some brain markers were identified, such as baseline brain structure in MDD, functional connectivity changes in schizophrenia and AUD, and motor network modulation in stroke, the strength and direction of these effects varied across studies.Conclusions: Significant heterogeneity and limited MRI-tDCS trials currently hinder mechanisms and biomarker establishment of tDCS. Future research should focus on standardizing MRI acquisition and analysis, which can improve reproducibility, and support robust findings.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"533-545"},"PeriodicalIF":2.7,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147380245","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

Authors' reply to comments on 'emerging monitoring techniques in oral appliance therapy for sleep apnea: a narrative review with a focus on mandibular jaw movement analysis'. 作者对“口腔器械治疗睡眠呼吸暂停的新兴监测技术：以下颌运动分析为重点的叙述性回顾”评论的回复。

IF 2.7

Expert review of medical devices Pub Date : 2026-05-01 Epub Date: 2026-03-04 DOI: 10.1080/17434440.2026.2640194

Jean-Benoît Martinot, Benjamin Tong, Nhat-Nam Le-Dong, Jean-Louis Pépin, Peter A Cistulli

引用次数: 0

Evolution of AI-based software as a medical device: from static tools to adaptive clinical partners. 基于人工智能的软件作为医疗设备的演变：从静态工具到适应性临床合作伙伴。

IF 2.7

Expert review of medical devices Pub Date : 2026-05-01 Epub Date: 2026-03-05 DOI: 10.1080/17434440.2026.2638365

Farshid Babapour Mofrad

引用次数: 0

From fragmentation to framework: why early regulatory advice is critical for European medical device innovation. 从碎片化到框架化：为什么早期监管建议对欧洲医疗器械创新至关重要。

IF 2.7

Expert review of medical devices Pub Date : 2026-05-01 Epub Date: 2026-03-03 DOI: 10.1080/17434440.2026.2640201

Tom Melvin, Giuditta Callea, Andrea Rappagliosi

引用次数: 0

Current progress of active compliance control strategies and applications in lower limb exoskeleton rehabilitation robots: a narrative review. 主动顺应控制策略及其在下肢外骨骼康复机器人中的应用进展综述。

IF 2.7

Expert review of medical devices Pub Date : 2026-05-01 Epub Date: 2026-03-05 DOI: 10.1080/17434440.2026.2640198

Sujiao Li, Yixin Yang, Shuyi Cheng, Lei Zhang, Hongliu Yu

{"title":"Current progress of active compliance control strategies and applications in lower limb exoskeleton rehabilitation robots: a narrative review.","authors":"Sujiao Li, Yixin Yang, Shuyi Cheng, Lei Zhang, Hongliu Yu","doi":"10.1080/17434440.2026.2640198","DOIUrl":"10.1080/17434440.2026.2640198","url":null,"abstract":"Introduction: With the increasing requirements for performance and safety of lower limb exoskeleton rehabilitation robots, researchers are exploring various active compliance control strategies to improve the compliance of control and enhance safety and effectiveness of rehabilitation training. The focus of this paper is to evaluate existing active compliance control strategies applied to lower limb exoskeleton rehabilitation robots, highlighting their principles, key technologies, and performance.Areas covered: Literature searches were conducted in PubMed and Web of Science from 2000 to 2025, starting with the broad keyword 'active compliance control strategy' and narrowing down to specific aspects such as 'impedance control'. Sixty-nine articles were reviewed, and eight active compliance control strategies were divided into three categories according to their core principles: impedance control (n = 18), force, and position hybrid control (n = 27) and machine learning-based hybrid control (n = 24). Their applications in five types of lower limb exoskeleton rehabilitation robots are outlined.Expert opinion: Active compliance control strategies for lower limb exoskeleton rehabilitation robots are necessary for safe human-robot interaction and assist-as-needed implementation. This paper envisions the concept of an active compliance controller that covers the entire rehabilitation cycle, ensuring that the robot is continuously aligned with the patient's rehabilitation needs.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"493-507"},"PeriodicalIF":2.7,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147319110","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