Expert review of medical devices最新文献

{"title":"Selection of central venous access devices for neonates: an expert review.","authors":"Sabrina de Souza, Mari Takashima, Deanne August, Tricia M Kleidon, Alina G Burek, Mary Beth Davis, Henrik Hjelmgren, Pranav Jani, Samantha Keogh, Amanda J Ullman","doi":"10.1080/17434440.2026.2741518","DOIUrl":"10.1080/17434440.2026.2741518","url":null,"abstract":"<p><strong>Introduction: </strong>Central venous access devices (CVADs) are essential for managing neonates requiring prolonged intravenous therapy. However, selecting the most appropriate CVAD remains complex due to population heterogeneity and variation in clinical practice, healthcare resources, and models of care.</p><p><strong>Areas covered: </strong>This expert review synthesizes current evidence and clinical guidance to support neonatal CVAD selection. It examines four major CVAD types - umbilical venous catheters, peripherally inserted central catheters, tunneled CVADs, and non-tunneled CVADs - focusing on their indications, contraindications, dwell times, and complication profiles. Device selection is discussed in relation to neonatal characteristics, therapy requirements, long-term vessel preservation, economic considerations, and healthcare context. This review integrates existing evidence to support individualized, context-informed decision-making across diverse models of care and identifies priorities for future research.</p><p><strong>Expert opinion: </strong>Optimal CVAD selection is not merely a technical decision but a strategic clinical process that integrates patient, therapy, device, and health-system factors. Existing frameworks provide valuable guidance and should be interpreted within the clinical context in which they are applied, acknowledging differences in expertise, available resources, and models of care. Continued advances in evidence generation, implementation, and neonatal-specific device innovation are essential to improving both immediate and lifelong vascular outcomes.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1229-1244"},"PeriodicalIF":2.7,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149077034","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":"Safety and efficacy of indigenous ultrathin-strut versus international thin-strut drug-eluting coronary stents in percutaneous coronary intervention: a systematic review of randomized controlled trials.","authors":"Ashutosh Bhosale, Pandey Pratima, Anit Kumar Sinha, Mohammed Salim Karattuthodi, Shivaprakash Gangachannaiah, Girish Thunga, Basant Kumar, Padmakumar Ramachandran, Vivekanandan Kalaiselvan, Akshay Shelke, Krishna Murti, Rajesh Radhakrishnan","doi":"10.1080/17434440.2026.2746135","DOIUrl":"10.1080/17434440.2026.2746135","url":null,"abstract":"<p><strong>Introduction: </strong>Ultrathin-strut drug-eluting stents (DES) have been developed to enhance vascular healing and reduce restenosis following percutaneous coronary intervention (PCI). Indigenous biodegradable-polymer ultrathin-strut DES are increasingly used in high-burden settings; however, comparative evidence against internationally established thin-strut DES remains limited.</p><p><strong>Methods: </strong>This systematic review of randomized controlled trials was conducted according to PRISMA 2020 guidelines. PubMed, Embase, Scopus, Web of Science, and the Cochrane Central Register of Controlled Trials were searched from inception to December 2025. Trials comparing indigenous ultrathin-strut DES with internationally manufactured thin-strut DES in adult PCI populations were included. Primary outcomes were major adverse cardiac events/trial-defined composite endpoints. Secondary outcomes included myocardial infarction, target lesion and vessel revascularization, stent thrombosis, cardiac death, and all-cause mortality. Risk of bias was assessed using the Cochrane RoB-2 tool, and a narrative synthesis was performed.</p><p><strong>Results: </strong>Four randomized trials including 2,793 patients were analyzed. Indigenous stents demonstrated comparable rates of composite endpoints, myocardial infarction, repeat revascularization, and stent thrombosis across studies, with no consistent differences between groups.</p><p><strong>Conclusion: </strong>The available RCT evidence shows no consistent signal of superiority or inferiority between indigenous and international thin-strut DES. However, heterogeneity and limited trial numbers warrant larger studies with long-term follow-up and real-world materiovigilance.</p><p><strong>Protocol registration: </strong>CRD420251240469.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1275-1288"},"PeriodicalIF":2.7,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149129623","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":"Safety and effectiveness of ultrasound-guided versus open carpal tunnel release: a systematic review and meta-analysis of prospective controlled studies.","authors":"Kevin C Chung, Julie E Adams, Rohit Garg, Larry E Miller, Warren C Hammert","doi":"10.1080/17434440.2026.2740310","DOIUrl":"10.1080/17434440.2026.2740310","url":null,"abstract":"<p><strong>Background: </strong>This systematic review and meta-analysis compared the safety and effectiveness of ultrasound-guided carpal tunnel release (UGCTR) and open carpal tunnel release (OCTR).</p><p><strong>Methods: </strong>We searched Medline, Embase, and the Cochrane Central Register of Controlled Trials for prospective studies comparing blade-based UGCTR and OCTR. Random-effects meta-analysis compared time to return to normal activities; Boston Carpal Tunnel Questionnaire Symptom Severity (BCTQ-SSS) and Functional Status (BCTQ-FSS) scores, pain severity, and patient satisfaction at 3 and 12 months; and complications through 12 months.</p><p><strong>Results: </strong>Six studies (four randomized; 749 patients) were included. UGCTR was associated with earlier return to normal activities than OCTR (mean difference: -13.9 days; 95% CI: -27.5 to -0.3; <i>p</i> = 0.045), although this estimate was sensitive to removal of individual studies. No significant group differences were observed in BCTQ scores, pain severity, or patient satisfaction at 3 or 12 months, and heterogeneity was considerable for most outcomes. Complication rates did not significantly differ (4.4% vs. 4.1%; risk ratio: 1.11; 95% CI: 0.55 to 2.25; <i>p</i> = 0.77).</p><p><strong>Conclusions: </strong>Compared with OCTR, UGCTR was associated with earlier return to normal activities, with no significant group differences in other outcomes. The findings are limited by considerable heterogeneity and few eligible studies.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1289-1298"},"PeriodicalIF":2.7,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149070780","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":"Potential role of artificial intelligence in automating European Union medical device Regulation.","authors":"Kurinchi Gurusamy, Dean Barratt, Tim Marriott, Rachel Rodell","doi":"10.1080/17434440.2026.2727060","DOIUrl":"10.1080/17434440.2026.2727060","url":null,"abstract":"","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1161-1165"},"PeriodicalIF":2.7,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148868597","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":"Overcoming the opaque side of AI in healthcare: a lifecycle-based approach.","authors":"Elisabetta Bianchini, Lucia Billeci, Noemi Conditi, Florinda Coro, Alice Ravizza","doi":"10.1080/17434440.2026.2723944","DOIUrl":"10.1080/17434440.2026.2723944","url":null,"abstract":"<p><strong>Introduction: </strong>Transparency has emerged as a foundational condition for trustworthy Artificial Intelligence (AI) in healthcare. Despite its centrality, practical approaches to systematically operationalize transparency across the entire lifecycle of AI-enabled medical devices remain fragmented and insufficiently structured. This work addresses this gap by proposing a lifecycle-oriented operational approach to guide the consistent implementation and evaluation of transparency in AI-based medical technologies.</p><p><strong>Areas covered: </strong>A narrative synthesis of regulatory texts, international standards, and scientific literature related to software as a medical device (SaMD), the EU Medical Device Regulation (MDR), the EU Artificial Intelligence Act (AI Act), data-protection rules, and relevant ISO/IEC guidance. Using a SaMD lifecycle framework, we mapped transparency requirements to practical development, validation, and governance activities across ideation, data and design inputs, risk management, implementation/verification, technical and clinical validation, market placement, maintenance, and disposal.</p><p><strong>Expert opinion: </strong>Transparency must be engineered as a lifecycle property, not an afterthought. We propose nine operational measures - covering documented design assumptions and datasets, transparency-oriented risk and change control, traceability, subgroup and independent validation, usability-based explainability, calibrated clinical evaluation, structured labeling, version-controlled updates, and regulated end-of-life data handling - to support regulatory readiness, calibrated clinical trust, and safe real-world integration of AI in healthcare.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1171-1186"},"PeriodicalIF":2.7,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148809706","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":"Use of neurostimulation in patients with treatment-resistant depression: current options and future directions.","authors":"Yoshihiro Noda","doi":"10.1080/17434440.2026.2717170","DOIUrl":"10.1080/17434440.2026.2717170","url":null,"abstract":"<p><strong>Introduction: </strong>Treatment‑resistant depression (TRD) reflects persistent dysfunction across large‑scale neural networks despite adequate pharmacotherapy. Neuromodulation offers mechanistically grounded interventions capable of directly modulating circuit‑level abnormalities implicated in TRD.</p><p><strong>Areas covered: </strong>This expert review synthesizes established, emerging, convulsive, and invasive neuromodulation modalities, including repetitive transcranial magnetic stimulation (rTMS), theta burst stimulation, accelerated TMS, deep TMS, transcranial electrical stimulation, temporal interference stimulation, photobiomodulation, low-field magnetic stimulation, transcranial focused ultrasound, electroconvulsive therapy, magnetic seizure therapy, vagus nerve stimulation, and deep brain stimulation. For each modality, technological foundations, mechanisms, efficacy, safety, and implementation considerations are summarized. Recent regulatory approvals of at-home prescription devices highlight the growing role of accessible home-based neuromodulation. Comparative effectiveness across effect size, tolerability, cost, and patient selection is reviewed. Advances in connectivity-informed targeting, tractography-guided neuromodulation, dose optimization, and biomarker-driven stratification illustrate the transition toward precision platforms. Literature for this review was identified through a non-systematic PubMed search.</p><p><strong>Expert opinion: </strong>Neuromodulation is evolving from a last-line intervention to a precision tool for circuit recalibration. Future progress will be driven by individualized targeting, closed-loop and multimodal stimulation, mechanistic trials, and scalable home-based delivery models. International collaborative research will be essential for validating biomarkers and accelerating development of next-generation circuit-based therapeutics.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1195-1227"},"PeriodicalIF":2.7,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148984360","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":"India's medical device regulatory framework: a decade of transformation, international harmonization, and the road to global competitiveness.","authors":"Neha Kamble, Prajkta Balakshe, Atish Velhal, Prakash D Jadhav","doi":"10.1080/17434440.2026.2726324","DOIUrl":"10.1080/17434440.2026.2726324","url":null,"abstract":"<p><strong>Introduction: </strong>India's medical device regulatory landscape has undergone fundamental transformation over the past decade, with the Medical Device Rules (MDR) 2017 establishing the country's first purpose-built, risk-stratified regulatory architecture. This review examines that decade of reform to assess India's progress toward international regulatory harmonization and to identify priorities for further development.</p><p><strong>Areas covered: </strong>This structured narrative review traces legislative and institutional development from the Drugs and Cosmetics Act 1940 through five MDR 2017 amendments to 2024, benchmarks India's framework against the US FDA, EU MDR 2017/745, and the WHO Global Model Framework across ten regulatory domains, and assesses the regulatory-industrial nexus through the PLI scheme, Medical Device Parks, and NMDP 2023. A structured search of PubMed, ScienceDirect, and SpringerLink (2014-2024) was supplemented by gazette notifications, CDSCO guidance, and ministry and parliamentary publications.</p><p><strong>Expert opinion: </strong>India's reforms have generated measurable advances in device quality, patient safety, and affordability, positioning the framework substantively - though not fully - on par with leading global regulators, with persisting gaps in enforcement capacity, AI/ML governance, and device-data integration. Closing these gaps over the next 5 years should bring India's framework into closer alignment with IMDRF reference members.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1245-1259"},"PeriodicalIF":2.7,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149120587","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":"Routine microaxial left ventricular support during nonemergent high-risk PCI: an updated systematic review and meta-analysis with Bayesian and grade methodologies.","authors":"Ahmed Elmorsy Mohamed, Mustafa Abomohsen, Abdul Hakim Almakadma, Zeyad Kholeif, Aya Elalfy, Iyad Idries, Ahmed M Abdelkhalek, Ibrahim Elkhayat, Mohammed Ghannam, Osamah AlQassab, Azad Mojahedi, Ahmed Farid Gadelmawla, Rana Rashwan, Meena Farid, Moshe Gunsburg, Hal L Chadow","doi":"10.1080/17434440.2026.2737101","DOIUrl":"10.1080/17434440.2026.2737101","url":null,"abstract":"<p><strong>Introduction: </strong>Microaxial left ventricular support (MLVS; Impella, Abiomed) is increasingly used during nonemergent high-risk percutaneous coronary intervention (HR-PCI), although randomized evidence remains limited and device-related complications are a concern.</p><p><strong>Methods: </strong>PubMed/MEDLINE, Scopus, Web of Science, and the Cochrane Library were searched from inception through March 2026 for randomized and comparative observational studies of MLVS versus control during nonemergent HR-PCI. Random-effects meta-analysis, subgroup and sensitivity analyses, Bayesian modeling, risk-of-bias assessment, and GRADE were performed.</p><p><strong>Results: </strong>Ten studies including 7,875 patients were analyzed. MLVS was not associated with lower all-cause mortality overall (RR 1.17, 95% CI 0.81-1.67; I² = 82.1%). Exploratory analyses showed higher mortality estimates in randomized trials (RR 1.44, 95% CI 1.05-1.97) and studies of planned pre-PCI support (RR 1.52, 95% CI 1.17-1.97). Bayesian analysis yielded a median RR of 1.14 (95% CrI 0.80-1.65; Pr[RR >1]=77.2%). Myocardial infarction, stroke/cerebrovascular events, and MACE/MACCE were not significantly different, while major bleeding was increased (RR 1.92, 95% CI 1.14-3.23).</p><p><strong>Conclusions: </strong>Current evidence does not support routine prophylactic MLVS during nonemergent HR-PCI. Selective use may remain appropriate, but further adequately powered randomized trials are needed.</p><p><strong>Protocol registration: </strong>PROSPERO CRD420261358349.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1299-1312"},"PeriodicalIF":2.7,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149003198","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":"Correction.","authors":"","doi":"10.1080/17434440.2026.2715865","DOIUrl":"10.1080/17434440.2026.2715865","url":null,"abstract":"","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"i"},"PeriodicalIF":2.7,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148687040","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":"Transcatheter tricuspid valve replacement for severe tricuspid regurgitation: current and future perspectives.","authors":"Gianmaria Calamita, Pier Pasquale Leone, Ossama Elsaid, Matteo Sturla, Syed Rizvi, Jacopo Lin, Tadahisa Sugiura, Andrea Scotti, Aryeh Abelow, Manaf Assafin, Edwin Ho, Azeem Latib","doi":"10.1080/17434440.2026.2713742","DOIUrl":"10.1080/17434440.2026.2713742","url":null,"abstract":"<p><strong>Introduction: </strong>Severe tricuspid regurgitation (TR) is common, undertreated, and associated with significant morbidity and mortality. Transcatheter tricuspid valve replacement (TTVR) has emerged as a promising option for patients unsuitable for surgical repair or transcatheter edge-to-edge repair.</p><p><strong>Areas covered: </strong>This review examines the innovation trajectory, current device landscape, patient selection, imaging guidance, procedure-specific challenges, and future perspectives of TTVR. A systematic literature search was performed using PubMed/MEDLINE, Embase, and ClinicalTrials.gov, covering publications from January 2015 to May 2025, using search terms including 'transcatheter tricuspid valve replacement,' 'TTVR,' 'tricuspid regurgitation,' and device-specific names.</p><p><strong>Expert opinion: </strong>TTVR offers near-complete regurgitation elimination but remains anatomy- and mechanism-dependent. Its role is best defined in patients with anatomy unfavorable for repair. Optimal timing, device selection, antithrombotic management, and long-term durability require prospective validation through dedicated trials and head-to-head comparisons with repair strategies.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1261-1273"},"PeriodicalIF":2.7,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148857917","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}