{"title":"Accuracy of thoracolumbar pedicle screw placement using intraoperative CT navigation versus 3D-printed patient-specific guides integrated with virtual surgical planning: a comparative study.","authors":"Sutipat Pairojboriboon, Korakot Charakorn, Patcharapit Promoppatum","doi":"10.1080/17434440.2026.2687808","DOIUrl":"10.1080/17434440.2026.2687808","url":null,"abstract":"<p><strong>Background: </strong>3D-printed patient-specific pedicle screw guides (3DPSG) may provide accuracy comparable to intraoperative CT navigation (CTNav). Our 3DPSG workflow incorporates a virtual surgical planning (VSP) platform that uses deep-learning algorithms to automatically generate pedicle trajectories from CT data.</p><p><strong>Research design and methods: </strong>This is a retrospective, single surgeon, single center comparative study of 21 patients undergoing thoracolumbar instrumentation via CTNav (11 patients, 71 screws) and 3DPSG (10 patients, 65 screws). The accuracy was assessed postoperatively using Gertzbein-Robbins and Heary classification systems.</p><p><strong>Results: </strong>There were eight men and thirteen women. Gender, BMI, and diagnosis did not differ significantly between the CTNav and 3DPSG groups (<i>p</i> > 0.05). Accuracy was high in both cohorts. By Gertzbein-Robbins, safe placement (grades 0-1) was 97.1% (69/71) with CTNav and 100% (65/65) with 3DPSG. On the Heary system, safe placement (grades 1-2) was 98.6% (70/71) and 100% (65/65), respectively. Malpositions occurred only in the CTNav group (Gertzbein grade 2: 2/71, 2.8%; Heary grade 3: 1/71, 1.4%). Overall accuracy did not differ significantly between groups (Fisher's exact test, <i>p</i> > 0.05).</p><p><strong>Conclusions: </strong>3DPSG integrated with VSP platform may be a viable alternative navigation system in middle-income settings where intraoperative CTNav is unaffordable.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"845-853"},"PeriodicalIF":2.7,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148274280","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}
Xiaofeng Li, Yu Liu, Jie Jia, Chaojiong Zhen, Yongguang Yuan
{"title":"Prismatic treatment combined with binocular visual training for intermittent exotropia: impact on visual function and quality of life.","authors":"Xiaofeng Li, Yu Liu, Jie Jia, Chaojiong Zhen, Yongguang Yuan","doi":"10.1080/17434440.2026.2696442","DOIUrl":"https://doi.org/10.1080/17434440.2026.2696442","url":null,"abstract":"<p><strong>Background: </strong>Given the high prevalence and progressive nature of intermittent exotropia (IXT), effective interventions are urgently needed. We aimed to probe the impact of prism combined with binocular visual training (BVT) on visual function and quality of life in patients with IXT.</p><p><strong>Research design and methods: </strong>This was a randomized controlled trial. Eighty-six IXT patients were randomly assigned to the control group (prism only) and experimental group (prism + BVT). Outcomes included strabismus angle, fusion range, stereopsis function, uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), tear film breakup time (TBUT), and refraction, quality of life [Chinese version of intermittent exotropia questionnaires (CIXTQ) scores], and visual discomfort symptoms.</p><p><strong>Results: </strong>After treatment, compared with the control group, the experimental group showed greater improvements in 33 cm and 6 m strabismus prism diopter, strabismus circular angle, fusion range, distant and near stereopsis detection rates, correct eye alignment, UCVA, BCVA, TBUT, and refraction (<i>p</i> < 0.05). Additionally, the experimental group had higher CIXTQ scores for social psychology and visual function, and a lower incidence of visual discomfort symptoms (<i>p</i> < 0.05).</p><p><strong>Conclusion: </strong>Prism combined with BVT effectively improves visual function and quality of life in IXT patients, demonstrating safety and clinical value.</p><p><strong>Clinical trial registration: </strong>https://www.chictr.org.cn/index.html. Clinical Trial Registration Number: ChiCTR2200112320.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2026-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148347974","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}
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":"<p><strong>Introduction: </strong>This scoping review mapped common specifications, standards and overlapping regulations for high-risk and innovative medical devices (MDs) and <i>in vitro</i> diagnostic medical devices (IVDs) in the European Union (EU), United States (US) and China to clarify compliance pathways and support regulatory harmonization.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"611-631"},"PeriodicalIF":2.7,"publicationDate":"2026-06-01","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}
Janet E Bray, Carolina Malta Hansen, Christopher M Smith, Steven C Brooks
{"title":"How can we improve public understanding and use of automated external defibrillators?","authors":"Janet E Bray, Carolina Malta Hansen, Christopher M Smith, Steven C Brooks","doi":"10.1080/17434440.2026.2652380","DOIUrl":"10.1080/17434440.2026.2652380","url":null,"abstract":"","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"557-560"},"PeriodicalIF":2.7,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147597271","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}
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":"10.1080/17434440.2026.2672738","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Areas covered: </strong>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.</p><p><strong>Expert opinion: </strong>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.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"657-667"},"PeriodicalIF":2.7,"publicationDate":"2026-06-01","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}
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":"10.1080/17434440.2026.2669665","url":null,"abstract":"<p><strong>Introduction: </strong>The loss of motor function due to lower limb amputation may be compensated by a prosthetic leg. To improve their functionality, 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.</p><p><strong>Areas covered: </strong>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.</p><p><strong>Expert opinion: </strong>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.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"561-574"},"PeriodicalIF":2.7,"publicationDate":"2026-06-01","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}
{"title":"Medical device errors in intensive care units and patient safety: a systematic review.","authors":"Zerin Ziaudeen, Selvam Jesiah, Anusha Dakshinamoorthi","doi":"10.1080/17434440.2026.2649555","DOIUrl":"10.1080/17434440.2026.2649555","url":null,"abstract":"<p><strong>Introduction: </strong>Medical device errors in Intensive Care Units (ICUs) position a critical threat to patient safety due to the complexity of devices, high patient alertness, and demanding clinical situations. Despite rising support on medical technologies, evidence on the nature of causes and prevention of device-oriented errors in ICUs remains fragmented.</p><p><strong>Methods: </strong>The PRISMA guidelines were followed throughout the systematic review, and the review was registered in PROSPERO (CRD42023424716). Studies published between 2010 and 2025 were accounted through 17 databases. The studies on medical device errors in adult, pediatric, and neonatal ICUs were encompassed, and the outcomes were synthesized qualitatively.</p><p><strong>Results: </strong>Seventy-two studies were covered and infusion pumps, syringe pumps, ventilators, and monitoring equipments were majorly associated with medical device errors. Errors were primarily related with human factors, device design flaws, and system failures. Infusion pump errors occurred in 60% of infusion initiations (80,209/133,601), while 89% of arrhythmia alarms were false positive among 2.5 million monitor alerts recorded in a cohort of 461 ICU patients.</p><p><strong>Conclusion: </strong>Medical device errors in ICUs are multifactorial. Effective prevention requires integrated approaches encompassing human factors engineering, focused training, improved device design, and a strong resilient patient safety culture.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"681-697"},"PeriodicalIF":2.7,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147517582","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}
Connor Cook, Asaad Beshish, Lindsey Malloy-Walton, Awni M Al-Subu
{"title":"The AtriAmp: a review of a novel device for atrial electrogram monitoring.","authors":"Connor Cook, Asaad Beshish, Lindsey Malloy-Walton, Awni M Al-Subu","doi":"10.1080/17434440.2026.2645806","DOIUrl":"10.1080/17434440.2026.2645806","url":null,"abstract":"<p><strong>Introduction: </strong>Arrhythmias following cardiac surgery are a common occurrence. Continuous atrial electrograms (AEG) are a valuable diagnostic tool, though barriers often limit their use. The AtriAmp is a device designed to enable continuous AEG monitoring using existing bedside telemetry systems.</p><p><strong>Areas covered: </strong>This review summarizes postoperative arrhythmia monitoring, limitations of existing technologies, and the AtriAmp. A literature search was conducted in PubMed and Google Scholar (2000-2025) using keywords 'postoperative arrhythmia,' 'atrial electrogram,' 'AtriAmp,' and 'electrophysiology.' References from limited relevant articles were also reviewed.</p><p><strong>Expert opinion: </strong>AtriAmp displays real-time AEGs alongside surface ECG using temporary atrial pacing leads. Published evidence remains very limited with no prospective comparative studies to date demonstrating improved clinical outcomes. Available reports suggest AtriAmp may improve clinician diagnostic confidence and reduce uncertainty in selected postoperative arrhythmia scenarios. Important limitations of the AtriAmp include single-use design, reliance on surgically placed epicardial wires, amplifier saturation during pacing, the need for provider training, and a per-patient disposable cost. Nonetheless, its potential to reduce diagnostic uncertainty, guide timely interventions, and optimize postoperative outcomes is substantial. AtriAmp should therefore be viewed as an adjunct diagnostic tool, with multicenter prospective studies needed to define the target population, quantify clinical impact, and establish cost-effectiveness.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"575-581"},"PeriodicalIF":2.7,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147470620","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}
{"title":"Evaluating regulatory oversight through major <i>in vitro</i> diagnostic recalls: a retrospective study of FDA data (2015-2024).","authors":"Simran Simran, Akash Thakur, Akash Kacharu Ahire, Saurabh Srivastava, Amit Asthana","doi":"10.1080/17434440.2026.2669127","DOIUrl":"10.1080/17434440.2026.2669127","url":null,"abstract":"<p><strong>Background: </strong><i>In vitro</i> diagnostic (IVD) devices play pivotal role in disease management by enabling an accurate and timely diagnosis. Diagnostic inaccuracies can harm public health by delaying or misguiding treatment.</p><p><strong>Method: </strong>A systematic analysis of the publicly available U.S. FDA recall database (201-2024) was conducted to evaluate the trends in Class I IVD recalls, focusing on approved class, recall reasons, manufacturers, and premarket notification (510 k) exemption status. Class II and III recalls were excluded from this study.</p><p><strong>Result: </strong>Between 2015 and 2024, a total of 100 Class I recall IVDs were reported. Over these 10 years, the major recalls were limited to Approval-Class I (<i>n</i> = 31) and Class II (<i>n</i> = 69) IVDs. Among the Approval-Class I IVDs (31), 12 were attributed to deficiencies in process control. In Approval-Class II, nine recalls were attributed to process control issues, non-conforming materials, device design, labeling change control, and other flaws. Notably, 23 of 31 Approval-Class I IVDs were 510(k)-exempt.</p><p><strong>Conclusion: </strong>Improving process control, device design, and manufacturing is essential to reducing Class I IVD recalls. Strengthening regulatory strategies through harmonized quality standards and AI-based post-market surveillance can help detect safety issues early, enhancing patient safety and public health outcomes.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"723-731"},"PeriodicalIF":2.7,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147864873","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}
Hongzhe Li, Zexin Chen, Li Wan, Zhangliang Li, Yun-E Zhao
{"title":"Red reflex examination for early detection of pediatric cataract using a novel red-reflex screening device.","authors":"Hongzhe Li, Zexin Chen, Li Wan, Zhangliang Li, Yun-E Zhao","doi":"10.1080/17434440.2026.2646442","DOIUrl":"10.1080/17434440.2026.2646442","url":null,"abstract":"<p><strong>Background: </strong>Early detection of pediatric cataracts is essential to prevent irreversible visual impairment; however, effective screening remains limited in many settings. This study evaluated the diagnostic performance of the CatScreener, a self-designed handheld red-reflex screening device, when operated by non-expert examiners.</p><p><strong>Methods: </strong>A total of 250 eyes from 250 infants and young children (≤8 years) underwent CatScreener screening and slit-lamp examination. Images were independently interpreted by two medical students and two junior ophthalmologists. Diagnostic outcomes were compared with an expert-defined reference standard. Cumulative summation (CUSUM) analysis was used to assess the learning curve for operational proficiency.</p><p><strong>Results: </strong>Diagnostic accuracy did not differ significantly between CatScreener screening and slit-lamp examination across all examiners (all <i>p</i> > 0.05). The CatScreener demonstrated high sensitivity (84.9%-87.1%) and specificity (89.2%-91.0%), with excellent agreement with slit-lamp examination (Kappa = 0.856-0.952) and good inter-examiner consistency (Kappa = 0.792-0.920). Sensitivity and specificity remained stable across chronological operation stages and age-stratified subgroups. CUSUM analysis indicated that approximately 50 cases were required to achieve operational proficiency.</p><p><strong>Conclusions: </strong>The CatScreener is an effective and user-friendly tool for the early detection of pediatric cataracts, demonstrating high diagnostic accuracy, strong agreement with conventional examination methods, and consistent performance across examiners with varying levels of clinical experience.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"713-721"},"PeriodicalIF":2.7,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147461335","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}