Expert review of medical devices最新文献_第2页

Comment on 'comparative validation of handheld fractional exhaled nitric oxide measurements'. 评论“手持式分数呼气一氧化氮测量的比较验证”。

IF 2.7

Expert review of medical devices Pub Date : 2025-10-01 Epub Date: 2025-08-22 DOI: 10.1080/17434440.2025.2546474

Florian Mirschinka, Thomas Keller, Sandra Wegner, Kai M Beeh

引用次数: 0

Profile of the Respimat soft mist inhaler for chronic obstructive pulmonary disease treatment: overview of its safety and efficacy. 用于慢性阻塞性肺疾病治疗的呼吸呼吸软雾吸入器的概况：其安全性和有效性概述。

IF 2.7

Expert review of medical devices Pub Date : 2025-10-01 Epub Date: 2025-08-29 DOI: 10.1080/17434440.2025.2554764

Alessandra Sorano, Francesca Buttini, P N Richard Dekhuijzen, Omar S Usmani, Federico Lavorini

{"title":"Profile of the Respimat soft mist inhaler for chronic obstructive pulmonary disease treatment: overview of its safety and efficacy.","authors":"Alessandra Sorano, Francesca Buttini, P N Richard Dekhuijzen, Omar S Usmani, Federico Lavorini","doi":"10.1080/17434440.2025.2554764","DOIUrl":"10.1080/17434440.2025.2554764","url":null,"abstract":"Introduction: The Respimat Soft Mist Inhaler (SMI), introduced in the early 2000s, represented a significant, represented a significant advancement in inhaled drug delivery for chronic obstructive pulmonary disease (COPD). It offers improved lung deposition, lower oropharyngeal impaction, and enhanced ease of use compared to traditional pressurized or dry powder inhalers.Area covered: This review provides an up-to-date overview of the Respimat SMI's design, inhaler performance, aerosol and lung deposition characteristics, clinical efficacy, patient-reported outcomes, and environmental impact. Comparative data with pressurized metered-dose inhalers (pMDIs), dry powder inhalers (DPIs), and emerging generic alternatives (e.g. MRX004) are critically discussed. The review also addresses usability, patient preference, and the increasing shift toward reusable, propellant-free inhalation platforms.Expert opinion: Respimat provides an effective, user-friendly alternative to conventional inhalers, especially for patients with suboptimal inspiratory flow or poor coordination Its fine-particle aerosol, high peripheral deposition, and environmentally sustainable design align with evolving clinical, economic, and policy priorities. Although further real-world data are needed, particularly regarding long-term adherence and device mastery, Respimat sets a benchmark for future inhaler innovation in terms of therapeutic performance, sustainability, and patient-centered care.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1093-1103"},"PeriodicalIF":2.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144983735","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

Post-operative infection with a single-use ureteroscope with real-time intrarenal pressure monitoring vs. all other single-use ureteroscopes. 实时肾内压监测的一次性输尿管镜与所有其他一次性输尿管镜术后感染对比。

IF 2.7

Expert review of medical devices Pub Date : 2025-10-01 Epub Date: 2025-09-16 DOI: 10.1080/17434440.2025.2557403

Naeem Bhojani, Kathryn Morris, Jenifer White, Sirikan Rojanasarot, Emma D Tran, Manoj Monga

{"title":"Post-operative infection with a single-use ureteroscope with real-time intrarenal pressure monitoring vs. all other single-use ureteroscopes.","authors":"Naeem Bhojani, Kathryn Morris, Jenifer White, Sirikan Rojanasarot, Emma D Tran, Manoj Monga","doi":"10.1080/17434440.2025.2557403","DOIUrl":"10.1080/17434440.2025.2557403","url":null,"abstract":"Background: Evidence for LithoVue™ Elite Single-Use Digital Flexible Ureteroscope (LVE) with pressure monitoring vs. other single-use ureteroscopes is needed.Research design and methods: This study using US electronic health records evaluated patients undergoing ureteroscopy (URS) with laser lithotripsy between 1 January 2023 and 1 June 2025. The primary endpoint was post-operative infection, defined as urinary tract infection (UTI), sepsis, and other infections, assessed at 10- and 30-days post-index procedure. Propensity score matching controlled for baseline differences.Results: After matching, 208 patients with LVE with pressure monitoring (mean age 61.4; 48.1% female; 79.3% White) and 416 with other single-use ureteroscopes without pressure monitoring (mean age 61.8; 48.1% female; 78.1% White) were evaluated. Post-operative LVE with pressure monitoring infection was significantly lower at 30 days post-index (8.2% vs. 15.4%; p = 0.016). Multivariable analyses confirmed significantly higher odds of 30-day infection with other single-use ureteroscopes (odds ratio 2.09 [95% confidence interval 1.19-3.86]; p = 0.014). Post-operative sepsis and other infections did not statistically differ; however, post-operative 30-day UTI was significantly less with LVE with pressure monitoring (5.2% vs. 10.8%; p = 0.033).Conclusions: LVE with pressure monitoring was associated with reduced 30-day post-URS infection. These findings support clinical improvement with LVE and suggest that intrarenal pressure monitoring may contribute to better short-term outcomes.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1135-1143"},"PeriodicalIF":2.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145002221","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

Correction. 修正。

IF 2.7

Expert review of medical devices Pub Date : 2025-10-01 Epub Date: 2025-09-07 DOI: 10.1080/17434440.2025.2558270

引用次数: 0

Comparison of laryngeal exposure in bed-up-head-elevated Macintosh laryngoscopy vs. supine C-MAC video laryngoscopy: a randomized non-inferiority trial. 床头抬高的Macintosh喉镜与仰卧位C-MAC视频喉镜下喉部暴露的比较：一项随机非效性试验。

IF 2.7

Expert review of medical devices Pub Date : 2025-10-01 Epub Date: 2025-09-10 DOI: 10.1080/17434440.2025.2559885

Prashant Sirohiya, Hari Krishna Raju Sagiraju, Vasudha Ahuja, Nishkarsh Gupta, Vinod Kumar, Brajesh Kumar Ratre, Balbir Kumar, Saurabh Vig, Raghav Gupta, Shweta Bhopale, Anuja Pandit, Sushma Bhatnagar

{"title":"Comparison of laryngeal exposure in bed-up-head-elevated Macintosh laryngoscopy vs. supine C-MAC video laryngoscopy: a randomized non-inferiority trial.","authors":"Prashant Sirohiya, Hari Krishna Raju Sagiraju, Vasudha Ahuja, Nishkarsh Gupta, Vinod Kumar, Brajesh Kumar Ratre, Balbir Kumar, Saurabh Vig, Raghav Gupta, Shweta Bhopale, Anuja Pandit, Sushma Bhatnagar","doi":"10.1080/17434440.2025.2559885","DOIUrl":"10.1080/17434440.2025.2559885","url":null,"abstract":"Background: Tracheal intubation can be challenging, especially in unanticipated cases, where patient positioning plays a critical role. The bed-up-head-elevated (BUHE) position may improve intubation outcomes.Research design and methods: This randomized non-inferiority trial included 90 ASA I-II patients undergoing elective surgery. Patients were randomly allocated into two groups. Group 1 underwent Macintosh laryngoscopy in the BUHE position followed by C-MAC laryngoscopy in the supine position, while Group 2 followed the reverse order. Endotracheal intubation was attempted with the second blade used for laryngoscopy. Laryngeal exposure was evaluated using Percentage of Glottic Opening (POGO) scores and Cormack - Lehane (CL) grading with a non-inferiority margin of -15% for POGO scores. Secondary outcomes included time required for intubation, attempts, adjuncts, effort, and complications.Results: BUHE Macintosh laryngoscopy yielded a mean POGO score of 50.5% compared to 63.4% with supine C-MAC laryngoscopy, with a mean difference of -12.9% (95% CI: -16.6% to -9.3%). CL grading favored C-MAC, while secondary outcomes showed no significant differences.Conclusion: BUHE Macintosh laryngoscopy resulted in lower laryngeal exposure, as the confidence interval crossed the non-inferiority margin. However, secondary outcomes remained comparable. Further studies are required to validate these findings and refine non-inferiority margins.Trial registration-: CTRI/2023/02/050036.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1145-1152"},"PeriodicalIF":2.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145024940","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 development of a novel device to aid in capillary macro blood self-sampling via an iterative study design. 一种新型装置的开发，以帮助在毛细管宏观血液自采样通过迭代研究设计。

IF 2.7

Expert review of medical devices Pub Date : 2025-10-01 Epub Date: 2025-08-25 DOI: 10.1080/17434440.2025.2553046

Corinne Herrijgers, Ella Van Landeghem, Fien Vanroye, Vicky Cuylaerts, Chris Kenyon, Thibaut Vanbaelen, Kurt Van Lent, Bart Smekens, Saskia Decuypere, Evi Bosman, Natalie De Cock, Camille Couwenbergh, Ella Baert, Rien Wymeersch, Kristof Sorgeloos, Koen Beyers, Tim Dierickx, Dorien Van den Bossche, Tom Platteau, Irith De Baetselier

{"title":"The development of a novel device to aid in capillary macro blood self-sampling via an iterative study design.","authors":"Corinne Herrijgers, Ella Van Landeghem, Fien Vanroye, Vicky Cuylaerts, Chris Kenyon, Thibaut Vanbaelen, Kurt Van Lent, Bart Smekens, Saskia Decuypere, Evi Bosman, Natalie De Cock, Camille Couwenbergh, Ella Baert, Rien Wymeersch, Kristof Sorgeloos, Koen Beyers, Tim Dierickx, Dorien Van den Bossche, Tom Platteau, Irith De Baetselier","doi":"10.1080/17434440.2025.2553046","DOIUrl":"10.1080/17434440.2025.2553046","url":null,"abstract":"Background: Blood sampling is essential for infectious disease diagnosis and monitoring but often requires venipuncture, limiting accessibility. Self-sampling offers a decentralized alternative, yet current macro-blood sampling methods are scarce. The device was developed to enable standardized, user-friendly self-sampling of ≥ 500 µL capillary fingerprick blood.Research design and methods: Via an iterative, mixed-method approach, we optimized the Collect2Know device (C2K) across five prototypes (P1-P5). Usability, acceptability, and blood volume of each prototype were assessed among minimum 10 participants. A minimum threshold of 75% usability and acceptability, and 60% of users collecting minimum 500 µL guided device refinement.Results: The first prototype (P1) underperformed, leading to redesign. P2-P3 improved usability and acceptability but failed volume collection targets. P4 incorporated substantial improvements, making the prototype more intuitive, and 77.5% (31/40) achieved success in blood collection with usability and acceptability scores of 89.1% and 75.6%, respectively.Conclusions: This study highlights the value of an iterative study-design, in the early stages of device development. The C2K device will facilitate capillary fingerprick macro-bloodsampling. By shifting routine blood sampling to decentralized settings, the C2K device may have the potential to enhance access to diagnostics, reduce healthcare burdens, and support public health efforts in both high- and low-resource settings.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1127-1134"},"PeriodicalIF":2.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144983737","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

Future potential of responsive neurostimulation for the treatment of Lennox-Gastaut syndrome. 反应性神经刺激治疗lenox -胃综合征的未来潜力。

IF 2.7

Expert review of medical devices Pub Date : 2025-10-01 Epub Date: 2025-09-11 DOI: 10.1080/17434440.2025.2557406

Debopam Samanta

引用次数: 0

Echocardiographic assessment after transcatheter aortic valve replacement. 经导管主动脉瓣置换术后超声心动图评价。

IF 2.7

Expert review of medical devices Pub Date : 2025-09-29 DOI: 10.1080/17434440.2025.2567546

Kevin Gu, Abdulrahman Museedi, Vratika Agarwal, Rebecca T Hahn

{"title":"Echocardiographic assessment after transcatheter aortic valve replacement.","authors":"Kevin Gu, Abdulrahman Museedi, Vratika Agarwal, Rebecca T Hahn","doi":"10.1080/17434440.2025.2567546","DOIUrl":"10.1080/17434440.2025.2567546","url":null,"abstract":"Introduction: Aortic stenosis is one of the most common valvular diseases, especially in the elderly. Transcatheter aortic valve replacement (TAVR) has become a mainstay treatment of severe, symptomatic aortic stenosis. Echocardiography remains the critical diagnostic tool for procedural success, complications, and follow-up.Areas covered: In this review, we discuss the use of echocardiography for the assessment of transcatheter aortic valve (TAV) function. We summarize currently available data on expected mean gradients and effective orifice area in various valve types and sizes and how it may differ from invasive measurements. We also summarize the complexities of quantifying paravalvular TAV regurgitation and its impact on clinical outcomes.Expert opinion: The hemodynamics of a transcatheter aortic valve is highly dependent on the inflow fluid dynamics. Although high gradients are undesirable, it does not necessary correlate to worse outcomes and should be taken into account with other parameters for assessment of valve function. Accurate diagnosis of bioprosthetic valve degeneration and failure is crucial as the TAVR patient shifts to younger and less co-morbid population.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-11"},"PeriodicalIF":2.7,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145188142","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

Lightening their load: considering overweight complications in patients with hip implants. 减轻负荷：考虑髋关节植入患者的超重并发症。

IF 2.7

Expert review of medical devices Pub Date : 2025-09-29 DOI: 10.1080/17434440.2025.2567542

Maurice Weiss, Stefan Schroeder, Julian Zierke, Philipp Damm, Jan Philippe Kretzer

引用次数: 0

Non-invasive brain technologies and their role in clinical applications. 无创脑技术及其在临床应用中的作用。

IF 2.7

Expert review of medical devices Pub Date : 2025-09-25 DOI: 10.1080/17434440.2025.2563614

Gaurav Sharma, Shubhajit Roy Chowdhury

{"title":"Non-invasive brain technologies and their role in clinical applications.","authors":"Gaurav Sharma, Shubhajit Roy Chowdhury","doi":"10.1080/17434440.2025.2563614","DOIUrl":"10.1080/17434440.2025.2563614","url":null,"abstract":"Introduction: Noninvasive brain monitoring and stimulation techniques are widely used in research and clinical applications. These techniques allow researchers and clinicians to study and affect brain activity safely, without any risk associated with invasive procedures.Areas covered: The present review paper is focused on noninvasive brain monitoring and stimulation techniques. First, noninvasive brain monitoring techniques that are beneficial for clinical experts to detect neurological disorders are highlighted. These techniques also help to identify the exact locations where cognitive functions are disturbed. Second, noninvasive brain stimulation (NIBS) techniques that are provided to the patient's specific locations to improve the cognitive function by modulating the neuronal excitability are also discussed in this paper.Expert opinion: Several clinical studies provide strong evidence related to the improvement of cognitive functions of patients suffering from neurological disorders using NIBS procedures. Various studies are being carried out to upgrade the noninvasive brain monitoring and stimulation techniques combined with artificial intelligence (AI) as transformative tool for advancing personalized portable home-based care, which may be beneficial to improve the lifestyle of patients suffering from the neurological disorders.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-20"},"PeriodicalIF":2.7,"publicationDate":"2025-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145088599","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