Expert review of medical devices最新文献

Cell-free corneal stromal implants: a fit-for-purpose medical-device framework. 无细胞角膜基质植入物：适合用途的医疗设备框架。

IF 2.7

Expert review of medical devices Pub Date : 2026-10-16 DOI: 10.1080/17434440.2026.2751750

Youssef Shalaby, Neil Lagali

引用次数: 0

Mechanical ventilation before and during veno-venous extracorporeal membrane oxygenation. 静脉-静脉体外膜氧合前后机械通气。

IF 2.7

Expert review of medical devices Pub Date : 2026-10-15 DOI: 10.1080/17434440.2026.2749360

Marco Giani, Alessandro Vatta, Livia Foglia Manzillo, Carlo Riggio, Luigi Camporota, Emanuele Rezoagli

{"title":"Mechanical ventilation before and during veno-venous extracorporeal membrane oxygenation.","authors":"Marco Giani, Alessandro Vatta, Livia Foglia Manzillo, Carlo Riggio, Luigi Camporota, Emanuele Rezoagli","doi":"10.1080/17434440.2026.2749360","DOIUrl":"https://doi.org/10.1080/17434440.2026.2749360","url":null,"abstract":"Introduction: Veno-Venous Extracorporeal Membrane Oxygenation (VV ECMO) has revolutionized severe acute respiratory distress syndrome (ARDS) management by decoupling gas exchange from native lung function, minimizing ventilator-induced lung injury (VILI). However, optimizing mechanical ventilation before and during extracorporeal support remains unstandardized.Areas covered: Pre-ECMO management heavily influences survival, requiring clinicians to balance the cumulative 'dose' of injurious ventilation against cannulation timing. On ECMO, practice remains divided between an 'open lung approach,' using higher PEEP to prevent derecruitment, and a 'closed lung approach,' prioritizing low PEEP and near-complete lung rest. Transitioning to spontaneous breathing introduces a trade-off between preventing diaphragmatic atrophy and risking patient self-inflicted lung injury (P-SILI) from excessive transpulmonary pressure swings. This review synthesizes evidence, addresses key controversies on cardiopulmonary interplay and weaning, and outlines strategies for personalizing ventilation during VV ECMO. We searched in the Medline database from inception to August 2026 to identify relevant literature on the management of veno-venous ECMO in the pre-ECMO phase, on-support, and during the weaning phases from VV ECMO.Expert opinion: VV ECMO enables lung-protective ventilation and 'buys time' for native lung recovery, but optimal management across the pre-ECMO, on-support, and weaning phases remains non-standardized and requires individualized, physiology-driven strategies rather than fixed protocols.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2026-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149198639","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

Superabsorbent polymer and foam dressings for preventing sacral hospital-acquired pressure injury: a systematic literature review and exploratory matching-adjusted indirect comparisons. 高吸水性聚合物和泡沫敷料预防骶骨医院获得性压力损伤：系统文献综述和探索性匹配调整间接比较。

IF 2.7

Expert review of medical devices Pub Date : 2026-10-14 DOI: 10.1080/17434440.2026.2744387

Rachel Goldgrub, Vladica Veličković, Amit Gefen, Raj Jaywant Ahiwale, Amrinder Singh, Matthias Hunger, Vanita Tongbram

{"title":"Superabsorbent polymer and foam dressings for preventing sacral hospital-acquired pressure injury: a systematic literature review and exploratory matching-adjusted indirect comparisons.","authors":"Rachel Goldgrub, Vladica Veličković, Amit Gefen, Raj Jaywant Ahiwale, Amrinder Singh, Matthias Hunger, Vanita Tongbram","doi":"10.1080/17434440.2026.2744387","DOIUrl":"10.1080/17434440.2026.2744387","url":null,"abstract":"Introduction: Hospital-acquired pressure injuries remain an important patient-safety burden, yet direct evidence comparing prophylactic sacral dressing technologies is absent.Areas covered: Embase, MEDLINE, and the Cochrane Central Register of Controlled Trials were searched from database inception through 23 January 2026; supplementary searches were completed on 26 January 2026, and one eligible post-search publication was assessed separately. Twenty-five studies were included. Sacral pressure-injury incidence varied widely across settings and study designs. The single-arm SAP study reported no sacral pressure injuries among 50 participants (0.0%; two-sided Clopper-Pearson exact 95% confidence interval, 0.0-7.1%) Two unanchored matching-adjusted indirect comparisons examined population alignment for time to pressure injury and dressing utilization. Adjustment was restricted to available baseline covariates; important differences in pressure-injury risk, setting, follow-up, and prevention protocols remained.Expert opinion: The review supports prophylactic dressings as an adjunct to comprehensive prevention but does not establish the relative effectiveness of superabsorbent polymer and foam technologies.Registration: OSF M2ze7.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-20"},"PeriodicalIF":2.7,"publicationDate":"2026-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149120538","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

An anatomically contoured interbody cage is associated with reduced subsidence after oblique lumbar interbody fusion: a comparative cohort study. 解剖轮廓的椎间笼与斜腰椎椎间融合术后下沉减少有关：一项比较队列研究。

IF 2.7

Expert review of medical devices Pub Date : 2026-10-14 DOI: 10.1080/17434440.2026.2748185

Santiago Vildoza, Victor Chen, Stone Sima, Tobias Buzzai Wilson, David Edis

{"title":"An anatomically contoured interbody cage is associated with reduced subsidence after oblique lumbar interbody fusion: a comparative cohort study.","authors":"Santiago Vildoza, Victor Chen, Stone Sima, Tobias Buzzai Wilson, David Edis","doi":"10.1080/17434440.2026.2748185","DOIUrl":"https://doi.org/10.1080/17434440.2026.2748185","url":null,"abstract":"Background: This study compared subsidence and segmental lordosis correction between a novel anatomically contoured cage and a conventional wedge-shaped cage used for oblique lumbar interbody fusion (OLIF).Research design and methods: This retrospective cohort included 38 patients undergoing OLIF at 60 levels with bilateral pedicle screw fixation. Subsidence was defined as ≥2 mm endplate penetration assessed on six-month computed tomography. Generalized estimating equations accounted for within-patient clustering and adjusted for minimum Hounsfield units, with additional adjustment for age or operated level in separate models.Results: Subsidence occurred at 2/30 levels (6.7%) treated with the anatomically contoured cage and 10/30 (33.3%) treated with the conventional cage (p = 0.021). The conventional cage was associated with higher odds of subsidence in the primary model (odds ratio [OR] 5.45; 95% confidence interval [CI] 1.35-22.00; p = 0.017). This association remained significant after age adjustment (OR 4.68; 95% CI 1.02-21.46; p = 0.047), but not after operated-level adjustment (OR 4.44; 95% CI 0.80-24.68; p = 0.088). Subsidence was associated with less lordosis gain (adjusted difference -3.33°; 95% CI - 5.03 to -1.62; p < 0.001).Conclusions: The anatomically contoured cage was associated with lower subsidence, but this association was sensitive to operated-level adjustment. The small sample and non-randomized design warrant cautious interpretation and prospective confirmation.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2026-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149186986","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

Blurred boundaries: should drug-device interactions be reported under pharmacovigilance, materiovigilance, or both? 界限模糊：药物器械相互作用是否应在药物警戒、物质警戒或两者下报告？

IF 2.7

Expert review of medical devices Pub Date : 2026-10-14 DOI: 10.1080/17434440.2026.2750592

Ashutosh Bhosale, Muhammed Rashid, Shivaprakash Gangachannaiah, Akhiljith, Rajesh Radhakrishnan, Anshaj Sharma, Ritesh Giri

引用次数: 0

Pattern and texton-based feature descriptors for diabetic foot ulcer detection. 基于模式和文本的特征描述符用于糖尿病足溃疡检测。

IF 2.7

Expert review of medical devices Pub Date : 2026-10-13 DOI: 10.1080/17434440.2026.2740306

Mastanvali, N Hema Rajini, M Laxmaiah

引用次数: 0

Advances in non-invasive monitoring of drug delivery for neurodegenerative disorders. 神经退行性疾病药物递送的无创监测进展。

IF 2.7

Expert review of medical devices Pub Date : 2026-10-12 DOI: 10.1080/17434440.2026.2743929

Joseph Y Choi, John D Heiss

{"title":"Advances in non-invasive monitoring of drug delivery for neurodegenerative disorders.","authors":"Joseph Y Choi, John D Heiss","doi":"10.1080/17434440.2026.2743929","DOIUrl":"10.1080/17434440.2026.2743929","url":null,"abstract":"Introduction: Effective therapies for neurodegenerative disorders remain limited by the blood-brain barrier. However, improving delivery across this barrier is only one part of the challenge. Investigators must also determine whether a therapy reaches the intended brain region, engages its target, and produces a meaningful biological response.Areas covered: This narrative review examines emerging approaches for noninvasive monitoring of central nervous system drug delivery. The literature search included PubMed and Web of Science for studies published from 2005 until 2026. Imaging methods such as magnetic resonance imaging, positron emission tomography, and focused ultrasound provide spatial information about blood-brain barrier permeability, regional distribution, and target engagement. Theranostic nanoplatforms and nanocarrier tracking strategies make delivery agents visible, while blood-based biomarkers, biosensors, and wearable technologies offer complementary measures of pharmacodynamic response and functional change. The literature search prioritized peer-reviewed original studies, clinical trials, and recent translational work relevant to delivery verification, biological response, and treatment monitoring.Expert opinion: Noninvasive monitoring is shifting CNS drug delivery from a question of blood-brain barrier crossing to a broader framework for evaluating delivery success. Future trials should validate whether multimodal monitoring can guide dosing, patient selection, safety surveillance, and continuation of treatment.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-11"},"PeriodicalIF":2.7,"publicationDate":"2026-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149140040","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

When the interface fails: a patient-safety hazard hidden by the assumption of human error. 当界面出现故障时：人为错误的假设隐藏了患者安全隐患。

IF 2.7

Expert review of medical devices Pub Date : 2026-10-01 Epub Date: 2026-08-15 DOI: 10.1080/17434440.2026.2720197

Amar Alwitry

{"title":"When the interface fails: a patient-safety hazard hidden by the assumption of human error.","authors":"Amar Alwitry","doi":"10.1080/17434440.2026.2720197","DOIUrl":"10.1080/17434440.2026.2720197","url":null,"abstract":"Introduction: Medical-device safety surveillance is organized around two failure types: a device that malfunctions and a clinician who errs. A third category, harm arising at the interface between two individually compliant devices used in combination, fits neither model and is poorly captured. As combination and procedure-pack care becomes ubiquitous, the safety significance of this blind spot grows.Areas covered: This article examines why interface failure evades vigilance and incident-reporting systems, using the syringe-cannula junction in intraocular surgery as a documented exemplar. Evidence was identified through searches of PubMed/MEDLINE and Google Scholar (database inception to July 2026), the US FDA MAUDE adverse-event database, and professional-body safety publications, and comprises surveys, case series, health-economic and litigation analyses, and the small-bore connector (ISO 80369) standards literature. It argues that misattribution to human error is the principal mechanism of under-reporting and traces the resulting cost to patients and staff.Expert opinion: Interface failure is a distinct and legitimate object of safety attention that current systems do not see. Progress depends less on new devices than on whether surveillance acquires a reporting category for combination failure, pursues buried signals through trend analysis, and brings standards attention to high-consequence junctions.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1167-1170"},"PeriodicalIF":2.7,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148763042","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 device profile on the MAGiC ablation catheter for treatment of cardiac arrhythmia. MAGiC消融导管治疗心律失常的设备简介。

IF 2.7

Expert review of medical devices Pub Date : 2026-10-01 Epub Date: 2026-09-14 DOI: 10.1080/17434440.2026.2726323

Peter Karl Jacobsen, Aashi Mehrotra, Christian Jøns, Tommi Forss, Niels Cf Sandgaard, Xu Chen

{"title":"A device profile on the MAGiC ablation catheter for treatment of cardiac arrhythmia.","authors":"Peter Karl Jacobsen, Aashi Mehrotra, Christian Jøns, Tommi Forss, Niels Cf Sandgaard, Xu Chen","doi":"10.1080/17434440.2026.2726323","DOIUrl":"10.1080/17434440.2026.2726323","url":null,"abstract":"Introduction: Catheter ablation is standard of care for cardiac arrhythmias, but conventional catheters are still limited by single-plane steering, variable tissue contact, and high irrigation demands, particularly in complex anatomy. Robotic magnetic navigation (RMN) addresses several of these constraints, but it has long depended on a first-generation radiofrequency catheter.Areas covered: This device profile reviews the design, mechanism of action, available clinical evidence, regulatory status and future development of the MAGiC magnetic ablation catheter, the first purpose-built catheter for the Stereotaxis RMN platform. The catheter is used across the full arrhythmia spectrum, including supraventricular tachycardias, atrial fibrillation, and ventricular arrhythmias, with complex and congenital anatomy among its most demanding applications. The evidence is drawn from its first-in-human study, supporting bench and platform data, and a structured search of the peer-reviewed literature.Expert opinion: Early experience points to improved catheter stability, stable tip temperatures, and reduced irrigation relative to the predecessor RMN catheter. The evidence base remains small, single-arm and partly manufacturer-sponsored, however, and comparative and long-term data are not yet available.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1187-1194"},"PeriodicalIF":2.7,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148972891","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

Validity and reliability of an inertial measurement unit motion sensor as a tool for measuring cervical spine range of motion. 惯性测量单元运动传感器作为测量颈椎运动范围工具的有效性和可靠性。

IF 2.7

Expert review of medical devices Pub Date : 2026-10-01 Epub Date: 2026-08-28 DOI: 10.1080/17434440.2026.2723952

Michail Koutsoukos, Anastasia Spyridonidou, Georgios Sidiropoulos, Vasiliki Stefanouli, Zacharias Dimitriadis, Nikolaos Strimpakos, Ioannis Poulis, Savvas Spanos

{"title":"Validity and reliability of an inertial measurement unit motion sensor as a tool for measuring cervical spine range of motion.","authors":"Michail Koutsoukos, Anastasia Spyridonidou, Georgios Sidiropoulos, Vasiliki Stefanouli, Zacharias Dimitriadis, Nikolaos Strimpakos, Ioannis Poulis, Savvas Spanos","doi":"10.1080/17434440.2026.2723952","DOIUrl":"10.1080/17434440.2026.2723952","url":null,"abstract":"Objectives: Accurate measurement of Cervical Range of Motion (CROM) is essential for quantifying motor deficits, designing interventions, and monitoring rehabilitation effectiveness. This study evaluated the validity and reliability of an Inertial Measurement Unit (IMU) (the Wiva Science) motion sensor, for assessing active CROM.Methods: Sixty participants (22 male, 38 female) were enrolled for the validity study and fifty (32 male, 18 female) for the reliability study. Active CROM was measured at peak-range (participant's maximum comfortable active movement) and mid-range (participant-estimated halfway movement) positions using the IMU sensor and the Zebris motion capture system simultaneously. For reliability, a single examiner recorded three repetitions of each movement within a predetermined range.Results: Concurrent validity was excellent, with Pearson's r ranged 0.902-0.996 (bias 0.08-3.67). The Intraclass Correlation Coefficient (ICC) for the IMU sensor ranged from 0.66-0.96, indicating moderate to excellent reliability. The Standard Error of Measurement was 0.26°-1.02°, and the Smallest Detectable Change ranged 1.93%-20.21%.Conclusion: The IMU motion sensor is cost-effective tool for CROM assessment, but its validity and reliability must be treated with caution. While clinically applicable, adequate trunk stabilization is essential for accuracy. To optimize results, device calibration is recommended prior to measuring each individual movement along its respective axis.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1313-1323"},"PeriodicalIF":2.7,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148809744","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