Expert review of medical devices最新文献

Methodologies for mapping existent common specification, standards, and overlapping regulation for medical devices: a scoping review. 映射医疗器械现有的通用规范、标准和重叠法规的方法：范围审查。

IF 2.7

Expert review of medical devices Pub Date : 2026-05-09 DOI: 10.1080/17434440.2026.2669666

Francisco Teixeira, Carolina Travassos, Inês Urbano, Ioanna Kostopoulou, João Quintas, Kshitij Sharma, Maria Karela, Mariana Cláudio, Panagiotis Zoumpoulakis, Sílvia Antunes, Ana Brito

{"title":"Methodologies for mapping existent common specification, standards, and overlapping regulation for medical devices: a scoping review.","authors":"Francisco Teixeira, Carolina Travassos, Inês Urbano, Ioanna Kostopoulou, João Quintas, Kshitij Sharma, Maria Karela, Mariana Cláudio, Panagiotis Zoumpoulakis, Sílvia Antunes, Ana Brito","doi":"10.1080/17434440.2026.2669666","DOIUrl":"10.1080/17434440.2026.2669666","url":null,"abstract":"Introduction: This scoping review mapped common specifications, standards and overlapping regulations for high-risk and innovative medical devices (MDs) and in vitro diagnostic medical devices (IVDs) in the European Union (EU), United States (US) and China to clarify compliance pathways and support regulatory harmonization.Methods: Following Joanna Briggs Institute (JBI) and PRISMA-ScR guidance, we searched PubMed, Scopus/Embase and Web of Science for studies on MD/IVD regulation, standards and common specifications in the aforementioned territories. Eligible records were screened in two stages, with data extracted using a structured form and synthesized narratively by regulatory pathway, standards, common specifications, and guidelines.Results: Of 3093 records identified, 2262 were screened and 275 met inclusion criteria. Across jurisdictions, regulation converges on risk-based classification, lifecycle clinical evidence, quality management and post-market surveillance. Differences persist in evidentiary thresholds, implementation timelines, regulator/notified-body capacity and requirements for software, Artificial Intelligence (AI), laboratory-developed tests and local testing, which are particularly challenging for Small and Medium Enterprises (SMEs).Conclusions: Regulatory frameworks in these territories are aligned in principle but variably specified and implemented, creating complexity for global market access. Clearer guidance on common specifications, explicit expectations for emerging technologies and harmonized post-market evidence requirements may reduce duplication while maintaining patient safety.Protocol registration on OSF (www.osf.io), identifier is 10.17605/OSF.IO/5JEX8.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-21"},"PeriodicalIF":2.7,"publicationDate":"2026-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147847841","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

Are emotions measurable? A narrative review on wearable technologies between neuroscience and cardiology. 情绪是可测量的吗？神经科学与心脏病学之间可穿戴技术的叙述性回顾。

IF 2.7

Expert review of medical devices Pub Date : 2026-05-08 DOI: 10.1080/17434440.2026.2672738

Irene Cappadona, Francesco Corallo, Anna Anselmo, Piercataldo D'Aleo, Antonio Duca, Giuseppe Micali, Luigi Bibbò, Alessia Bramanti, Marina Garofano, Placido Bramanti, Maria Pagano

{"title":"Are emotions measurable? A narrative review on wearable technologies between neuroscience and cardiology.","authors":"Irene Cappadona, Francesco Corallo, Anna Anselmo, Piercataldo D'Aleo, Antonio Duca, Giuseppe Micali, Luigi Bibbò, Alessia Bramanti, Marina Garofano, Placido Bramanti, Maria Pagano","doi":"10.1080/17434440.2026.2672738","DOIUrl":"https://doi.org/10.1080/17434440.2026.2672738","url":null,"abstract":"Introduction: Understanding how emotional processes arise from interactions between the brain and heart is crucial for advancing integrated approaches to cardiovascular and mental health. Wearable technologies offer new opportunities to objectively evaluate this heart - brain relationship in real time.Areas covered: This narrative review examines studies evaluating emotional states using smart wearable devices used in cardiology. A literature search was conducted across PubMed, Web of Science, Cochrane Library, and Scopus, focusing on the past decade. From 2205 identified records, 9 studies were included. Both single-parameter (e.g. heart rate variability) and multi-parameter devices were analyzed to determine their effectiveness in detecting emotional states and supporting holistic cardiac health management.Expert opinion: Wearable devices represent a promising tool for linking emotional and cardiovascular dynamics, with single-parameter systems currently offering more reliable signal interpretation. Further research is needed to refine multi-parameter integration and enhance personalized, emotion-informed cardiac care.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147857785","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

Function and fatigue monitoring in neuromuscular electrically‑evoked exercise after spinal cord injury. 脊髓损伤后神经肌肉电诱发运动的功能和疲劳监测。

IF 2.7

Expert review of medical devices Pub Date : 2026-05-08 DOI: 10.1080/17434440.2026.2671939

Nur Azah Hamzaid, Jannatul Naeem

{"title":"Function and fatigue monitoring in neuromuscular electrically‑evoked exercise after spinal cord injury.","authors":"Nur Azah Hamzaid, Jannatul Naeem","doi":"10.1080/17434440.2026.2671939","DOIUrl":"https://doi.org/10.1080/17434440.2026.2671939","url":null,"abstract":"Introduction: Functional electrical stimulation (FES) can restore or augment movement in individuals with spinal cord injury (SCI), yet rapid neuromuscular fatigue limits training duration and the feasibility of closed‑loop control.Areas covered: We review FES control‑system components and sensory feedback modalities used to monitor function and fatigue in SCI, synthesizing evidence from kinetic and kinematic sensors, namely joint angle, torque, center of pressure, and muscle‑level sensors such as surface/evoked electromyography, mechanomyography, ultrasound, and electroencephalography. We outline how stimulation parameters i.e. amplitude, frequency, pulse width, are modulated within open‑ and closed‑loop architectures and summarize strategies to mitigate fatigue - frequency‑aware controllers, asynchronous/multiped stimulation.Expert opinion: Limited focus on fatigue is concerning, as effective fatigue management is crucial for developing closed-loop FES systems that support longer training sessions and improve long-term effectiveness and usability of rehabilitation interventions. Fatigue management must be embedded, not appended, within closed‑loop FES. Priority areas include frequency‑aware controllers, asynchronous/ multipad stimulation, and robust muscle‑state sensing, particularly mechanomyography and ultrasound, that is less vulnerable to stimulation artifacts than surface EMG.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147847697","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

Inspiratory muscle training devices for chronic lung disease management: current evidence and future directions. 慢性肺部疾病管理的吸气肌训练装置：目前的证据和未来的方向。

IF 2.7

Expert review of medical devices Pub Date : 2026-05-08 DOI: 10.1080/17434440.2026.2671944

Rogih Andrawes, Sophia Wang, Sahar Sohrabipour, Ewan C Goligher, Shaf Keshavjee, W Darlene Reid, Dmitry Rozenberg

{"title":"Inspiratory muscle training devices for chronic lung disease management: current evidence and future directions.","authors":"Rogih Andrawes, Sophia Wang, Sahar Sohrabipour, Ewan C Goligher, Shaf Keshavjee, W Darlene Reid, Dmitry Rozenberg","doi":"10.1080/17434440.2026.2671944","DOIUrl":"https://doi.org/10.1080/17434440.2026.2671944","url":null,"abstract":"Introduction: Inspiratory muscle training (IMT) is a potential adjunct therapy to improve inspiratory muscle strength and endurance, exercise capacity, health-related quality of life (HRQL) and symptoms in chronic lung diseases. A growing number of IMT devices are commercially available; however, their mechanisms, utilization, and supporting evidence vary.Areas covered: This narrative review summarizes IMT devices used in chronic lung diseases, including threshold trainers, flow-resistive devices, and isocapnic hyperpnea devices. A PubMed search to February 2026 identified studies that tested commercially available IMT devices in chronic lung disease and described their mechanism, usability and their efficacy or effectiveness. Manufacturer websites also provided device-specific information. Factors that influence IMT outcomes are described including: training intensity, duration, frequency, patient selection, and practical considerations.Expert opinion: IMT is a feasible intervention that improves inspiratory muscle strength and exercise capacity, commonly improving respiratory symptoms and HRQL. Device type (pressure-threshold versus flow-resistive) and practical factors, including cost, usability, supervision, and feedback capabilities may influence both training load and clinical response. Future directions include perioperative IMT as a prehabilitation strategy, the potential role of respiratory muscle memory, and the development of digital and artificial intelligence-enhanced IMT devices.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147857732","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

Ethical concerns regarding a lack of standardized clinical demographic data: an audit of 2023 FDA medical devices. 缺乏标准化临床人口统计数据的伦理问题：2023年FDA医疗器械审计

IF 2.7

Expert review of medical devices Pub Date : 2026-05-07 DOI: 10.1080/17434440.2026.2671943

Emma Whitehouse, Marianne Swain, Wesley Shumar

{"title":"Ethical concerns regarding a lack of standardized clinical demographic data: an audit of 2023 FDA medical devices.","authors":"Emma Whitehouse, Marianne Swain, Wesley Shumar","doi":"10.1080/17434440.2026.2671943","DOIUrl":"https://doi.org/10.1080/17434440.2026.2671943","url":null,"abstract":"IntroductionMedical devices have been regulated by the Food and Drug Administration since 28 May 1976. The FDA does not currently require that medical device companies publish diversity data across all device approval pathways. Demographic information is imperative because it enables stakeholders to note the safety of medical devices with different demographic groups. The aim of this article is to quantify the demographic information publicly available on the FDA's 2023 Device Approvals page.MethodsThe N = 52 medical devices available on the FDA's 2023 Device Approvals page were analyzed via qualitative coding with two coders and then checked for intercoder reliability using Cohen's Kappa.ResultsOf the medical devices on the webpage, only 59.6% reported all demographic variables included in the study (gender/sex, race, ethnicity, and age). Sex/Gender was reported 92.3% of the time, Race 75% of the time, Ethnicity 61.5% of the time, and Age 94.2% of the time.ConclusionMore stringent guidelines are needed for reporting demographic data with medical devices, which may lead to increased patient safety and personalized medicine.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2026-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147847690","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

Design and impact of systems for artificial sensory feedback in lower-limb prostheses. 下肢假肢人工感觉反馈系统的设计与影响。

IF 2.7

Expert review of medical devices Pub Date : 2026-05-04 DOI: 10.1080/17434440.2026.2669665

Jakob Dideriksen, Romain Valette, Martin Garenfeld, Sabina Manz, Jose Gonzalez Vargas, Strahinja Dosen

{"title":"Design and impact of systems for artificial sensory feedback in lower-limb prostheses.","authors":"Jakob Dideriksen, Romain Valette, Martin Garenfeld, Sabina Manz, Jose Gonzalez Vargas, Strahinja Dosen","doi":"10.1080/17434440.2026.2669665","DOIUrl":"https://doi.org/10.1080/17434440.2026.2669665","url":null,"abstract":"Introduction: The loss of motor function due to lower limb amputation may be compensated by a prosthetic leg. To improve their function, systems for artificial sensory feedback have been proposed, but have yet to reach widespread clinical use. This review aims to provide an overview of the design and impact of such systems.Areas covered: Based on a systematic literature search in the Pubmed and Embase databases (21 September 2025), we analyzed 63 studies proposing a total of 81 feedback systems. When categorized according to the feedback variable, pre-processing techniques (discretization), stimulation modality, and encoding technique used in each study, a total of 32 unique configurations were obtained. These systems were evaluated with respect to their impact on gait, balance, physiological parameters, or psychological and cognitive functions. The analysis revealed that despite the heterogeneity in system design, most configurations (84%) produced positive outcomes.Expert opinion: We identify important limitations related to the ecological validity and practical usability of the proposed feedback systems. Moreover, the degree to which systematic comparison could be made across studies was limited, preventing the identification of an optimal configuration. Finally, we proposed recommendations for future studies to overcome these limitations.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2026-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147825033","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

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

Rapid deployment valves: current position on the market and future directions. 快速部署阀门：目前在市场上的地位和未来的方向。

IF 2.7

Expert review of medical devices Pub Date : 2026-05-01 Epub Date: 2026-03-05 DOI: 10.1080/17434440.2026.2638363

Delphine Szecel, Marie Van den Bosch, Bart Meuris

{"title":"Rapid deployment valves: current position on the market and future directions.","authors":"Delphine Szecel, Marie Van den Bosch, Bart Meuris","doi":"10.1080/17434440.2026.2638363","DOIUrl":"10.1080/17434440.2026.2638363","url":null,"abstract":"Introduction: With an estimated prevalence of nine million people worldwide, calcific aortic valve stenosis is the most common valvular heart disease in North America and Western Europe. Although transcatheter procedures have expanded considerably over the past decade, surgical aortic valve replacement (SAVR) remains a reliable and trusted therapeutic option. Sutureless (SU) and rapid deployment valves (RDVs) are bioprostheses specifically designed for implantation during SAVR using few or no sutures.These bioprostheses offer well-recognized advantages, including ease of implantation and shorter operative times, although higher rates of permanent pacemaker implantation have been reported. Their use is also well documented in the context of minimally invasive surgery.Areas covered: This article presents a narrative overview of the current evidence on the benefits, limitations, and typical clinical indications of SU/RDV prostheses. Recent developments and potential future applications are also discussed.Expert opinion: In the context of a rapidly evolving treatment paradigm for aortic valve stenosis, SU and RDV bioprostheses have demonstrated their value as reliable devices for surgical valve replacement. Continued clinical research will be essential to better delineate which patients may benefit most as part of an individualized, lifetime valve-management strategy.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"469-473"},"PeriodicalIF":2.7,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147328635","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

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