Frontiers in medical technology最新文献

{"title":"Reported best practices for effective risk management of medical devices: a scoping review.","authors":"Rosario Luxardo, Arkeliana Tase, Florence Leong, Massimo Micocci, Martina Tognini, Peter Buckle, Melody Ni","doi":"10.3389/fmedt.2026.1863808","DOIUrl":"10.3389/fmedt.2026.1863808","url":null,"abstract":"<p><p>Risk management (RM) is an essential element for developing safe technologies and frequently a requirement by the regulators. The practice of RM spans from pre-to-post market stages, starting from product development and continuing after product launch. Technological advancements and shifting demands in healthcare led to rapid growth of new technologies such as AI, robotics and point of care diagnostics, presenting many unknowns to the RM process. This study aims to review best practices in medical device RM, highlight gaps and ambiguities in knowledge and identify priorities for future research. A thorough literature review was conducted in June 2025 in two parts: (A) assessment of official updated regulatory documents and guidelines for Medical Devices (MDs), and (B) review published literature for reported best practices in RM of MDs. Part A of the search focused on official regulatory agencies, and Part B of the search was conducted on OVID, Embase, Medline, PubMed, Engineering Village, Scopus, and Google Scholar. A 10-year and English as language limit was applied only for part B. Our search found 147 publications (16 were guidelines from regulatory agencies and 131 were from peer reviewed literature). A total of one regulatory document and 11 studies met the inclusion criteria. Step (A) ISO 14971 was the only regulatory document that explicitly described a structured process for RM. Step (B) Although no single best practice was identified, several recurring themes emerged. Significant best practices suggest the use of hybrid or multi-component frameworks (<i>n</i> = 5), the integration of qualitative and structured quantitative approaches (<i>n</i> = 3), incorporation of patient preferences (<i>n</i> = 2), inclusion stakeholder and end-user engagement (<i>n</i> = 1), and considerations of emerging system-level challenges, such as cybersecurity, was limited. Based on our findings, we advise targeted recommendations to strengthen current practices. In conclusion, many challenges exist in conducting an efficient RM process for medical devices, driven by variability in technology and specifications, which will increase as these technologies continue to evolve. Greater end-user involvement throughout all stages can help identify unknown hazards and improve medical technology safety.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"8 ","pages":"1863808"},"PeriodicalIF":4.6,"publicationDate":"2026-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13341656/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148414430","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Methodologies for generating and evaluating clinical and performance evidence for high-risk and innovative medical devices and <i>in vitro</i> diagnostics: a scoping review.","authors":"Nensi Bralić, Ružica Bandić, Miro Vuković, Danira Matijaca, Renata Valsami, Panagiotis Zoumpoulakis, Kalle Schnitzer, Mari Levula, Risto Roine, Antti Viitala, Antti Pihlava, Olivia McDermott, Ana Marušić","doi":"10.3389/fmedt.2026.1857401","DOIUrl":"10.3389/fmedt.2026.1857401","url":null,"abstract":"<p><strong>Introduction: </strong>High-risk and innovative medical devices (MDs) and <i>in vitro</i> diagnostic devices (IVDs) in the European Union are subject to increasingly stringent and evolving regulatory requirements. This scoping review maps methodological approaches to evidence generation across their life cycle.</p><p><strong>Methods: </strong>A comprehensive and systematic search of major bibliographic databases and grey literature sources was conducted (January 2025, updated November 2025). Studies were selected through dual independent screening using predefined inclusion criteria. Data were extracted using a structured approach and supported by AI-assisted thematic analysis. Findings were synthesized narratively to map methodological approaches to evidence generation and evaluation.</p><p><strong>Results: </strong>A total of 15,679 records were identified, with 14,259 remaining after duplicate removal and 859 full texts assessed for eligibility. Of these, 90 studies met the inclusion criteria. In addition, records identified through other methods were screened, with 75 progressing to full-text assessment; of these, 8 were included<b>.</b> Evidence generation for high-risk and innovative MDs and IVDs requires an integrated, life-cycle approach combining multiple study designs. While randomized controlled trials remain important, observational studies, real-world evidence, registries, and post-market surveillance are essential for assessing long-term safety and effectiveness. However, current practices show substantial variability, methodological limitations, and regulatory inconsistencies.</p><p><strong>Conclusions: </strong>An integrated lifecycle approach is needed for robust evaluation of high-risk and innovative MDs and IVDs. Strengthening methodological standards, improving the quality of real-world data, and enhancing regulatory harmonization are essential.</p><p><strong>Systematic review registration: </strong>Open Science Framework (OSF), doi: 10.17605/OSF.IO/XNBSP.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"8 ","pages":"1857401"},"PeriodicalIF":4.6,"publicationDate":"2026-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13341693/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148414424","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Transformer-based deep learning for estimating bidirectional maternal-fetal cardiac coupling.","authors":"Murad Almadani, Leontios Hadjileontiadis, Ahsan Khandoker","doi":"10.3389/fmedt.2026.1651162","DOIUrl":"10.3389/fmedt.2026.1651162","url":null,"abstract":"<p><strong>Introduction: </strong>Maternal-fetal cardiac coupling has emerged as a promising non-invasive marker of fetal autonomic regulation and neurocardiac development. However, existing approaches are limited by unidirectional modeling, handcrafted coupling metrics, and a lack of interpretable and clinically validated abnormality assessment frameworks.</p><p><strong>Methods: </strong>We propose a transformer-based deep learning framework for bidirectional maternal-fetal cardiac coupling analysis using heart rate variability (HRV) features. The model learns fetal-to-maternal (FTM) and maternal-to-fetal (MTF) interactions using two independently trained UNETR-based models with identical architecture and no shared weights. The framework is evaluated on a real clinical dataset, incorporating time-delay, gestational, and classification analyses.</p><p><strong>Results: </strong>Time-delay analysis revealed directional asymmetry, with MTF coupling peaking at 3 seconds and FTM at 5 seconds. Gestational analysis showed relatively stable MTF coupling, while FTM coupling was consistently reduced in abnormal cases. Classification using support vector machines demonstrated strong discrimination, with the full-feature model (MTF + FTM + gestational week) achieving ROC-AUC = 0.91 ± 0.08. Under class imbalance, the coupling-only model (MTF + FTM) achieved the highest PR-AUC, indicating robust minority-class sensitivity.</p><p><strong>Discussion: </strong>These findings suggest that bidirectional coupling analysis may provide useful insight into maternal-fetal physiological interactions. However, the results should be interpreted as proof-of-concept evidence due to the limited and heterogeneous abnormal cohort. Further validation on larger and more homogeneous datasets is required to assess the potential of this approach for non-invasive prenatal monitoring.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"8 ","pages":"1651162"},"PeriodicalIF":4.6,"publicationDate":"2026-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13337635/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148406893","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy assessment in trials of complex and rare diseases: a comparison between the meta-analytic global statistical test and co-primary analysis.","authors":"Samuel P Dickson, Abe Durrant, Caleb W Dayley, Joshua R Christensen, Craig H Mallinckrodt, Suzanne B Hendrix","doi":"10.3389/fmedt.2026.1819463","DOIUrl":"10.3389/fmedt.2026.1819463","url":null,"abstract":"<p><strong>Introduction: </strong>Choice of the primary outcome can be problematic in 1) diseases with heterogeneous signs and symptoms, 2) trials of disease-modifying treatments (DMTs) that are expected to affect all aspects of the disease, 3) in complex and rare diseases with minimal data on clinical trial outcomes. In such situations, a single outcome measuring a single domain of disease will rarely suffice as a primary outcome. To address this issue, regulatory bodies often suggest co-primary endpoints or require efficacy on both primary and key secondary endpoints for confirmatory trials, to ensure that at least two different domains of disease are affected by treatment. However, obtaining statistical significance on two outcomes is a much stricter requirement than on a single primary outcome. Global statistical tests (GST) combine multiple outcomes into a single score and could provide a viable alternative to the co-primary approach. Importantly for rare diseases, combining multiple assessments reduces the risk of selecting a poorly performing outcome simply because it has not been studied extensively.</p><p><strong>Methods: </strong>We conducted simulations to compare GST to single primary and co-primary endpoint approaches with two moderately or highly correlated outcomes with various effect sizes.</p><p><strong>Results: </strong>For scenarios with the same true effect size on both outcomes, the GST had greater power than single primary and co-primary approaches, regardless of the correlation level between outcomes. This was also true with different effect size combinations at the same correlation level. With an effect observed on one outcome only, GST was more likely to yield statistical significance than the co-primary approach. Unlike the co-primary approach, The GST yielded lower <i>p</i>-values in scenarios with lower correlation between the outcomes due to the independence of the information from each endpoint.</p><p><strong>Conclusions: </strong>Using GST as a prespecified endpoint is appropriate in trials where a clear primary endpoint has not been identified, sample sizes are insufficient to support multiple primary endpoints, and/or more comprehensive assessments across multiple endpoints are needed to fully evaluate outcomes.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"8 ","pages":"1819463"},"PeriodicalIF":4.6,"publicationDate":"2026-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13328443/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148393032","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Diffusion tensor imaging of the pelvic floor muscles and pelvic organs: a systematic review.","authors":"Yiting Wang, Shaojun Zhang, Yan Chen","doi":"10.3389/fmedt.2026.1772496","DOIUrl":"10.3389/fmedt.2026.1772496","url":null,"abstract":"<p><strong>Purpose: </strong>This paper provides a systematic review of the current applications of diffusion tensor imaging (DTI) in the imaging of pelvic floor-related anatomical structures and the assessment of microscopic pathological changes.</p><p><strong>Methods: </strong>A systematic search of the PubMed, EMBASE, and Cochrane Library databases was conducted, with a focus on studies involving the application of diffusion tensor imaging to pelvic organs and muscles. The search was conducted from the inception of each database through to 11 December 2025. The present study incorporated a range of research methodologies, including randomized controlled trials (RCTs) and observational studies. The screening and reporting phases of the study adhered to the PRISMA guidelines, while the quality assessment was conducted using the Oxford Centre for Evidence-Based Medicine (OEBM) evidence grading tool.</p><p><strong>Results: </strong>The final sample comprised a total of 30 studies. Of these, two studies reported the application of DTI on the anal canal and its diagnostic value for anal fistula. Five studies demonstrated the ability of DTI to visualize microstructural alterations in endometriosis and uterine fibroids by measuring uterine anisotropy fraction and fibre tracking. A total of 19 studies reported the utilization of DTI applications in the context of prostate and prostate tumor analysis. Four studies have documented its use in healthy pelvic muscles and pelvic floor dysfunction.</p><p><strong>Conclusion: </strong>The findings suggest that the application of diffusion tensor imaging metrics in the pelvic region may aid in the assessment of tissue microstructural disruption and the distinction between benign and malignant or inflammatory lesions through relevant parameters, thereby enhancing diagnostic specificity. As diffusion tensor imaging becomes increasingly utilized in imaging for treatment guidance, it is imperative to develop a comprehensive understanding of its application in the pelvic region.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"8 ","pages":"1772496"},"PeriodicalIF":4.6,"publicationDate":"2026-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13328171/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148393050","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical efficacy of the lateral decubitus position in the treatment of irreducible trochanteric fractures with bisection of the lesser trochanter.","authors":"Xiang Yu, Hong-Kui Hu, Yu-Zhi Li, Xiao-Kai Li, Fan-Cheng Chen, Xu Li, Hai-Jian Lu, Bao-Qing Yu, Rong-Guang Ao","doi":"10.3389/fmedt.2026.1853499","DOIUrl":"10.3389/fmedt.2026.1853499","url":null,"abstract":"<p><strong>Objective: </strong>To compare the clinical efficacy of the lateral decubitus position versus the supine traction table position in patients with irreducible trochanteric fractures featuring bisection of the lesser trochanter.</p><p><strong>Methods: </strong>We retrospectively analyzed 48 patients with this fracture pattern. Patients were divided into Group A (supine on traction table, <i>n</i> = 24) and Group B (lateral decubitus, <i>n</i> = 24). All underwent limited open reduction and PFNA fixation. We compared perioperative metrics (prep/time/fluoroscopy/blood loss), hospital stay, healing time, and 1-year outcomes (VAS, Harris score, reduction quality, complications).</p><p><strong>Results: </strong>Compared with the supine traction table group, the lateral decubitus group demonstrated significantly shorter preoperative preparation time (10.86 ± 2.24 vs. 18.21 ± 5.13 min, <i>P</i> < 0.001), total operative time (88.74 ± 20.72 vs. 118.45 ± 30.33 min, <i>P</i> = 0.010), fewer intraoperative fluoroscopies (58.24 ± 14.82 vs. 82.27 ± 25.44, <i>P</i> = 0.010), and reduced intraoperative blood loss (208.94 ± 67.55 vs. 288.56 ± 90.34 mL, <i>P</i> = 0.023). No significant differences were found in hospital stay, fracture healing time, or 1-year clinical/radiographic outcomes (<i>P</i> > 0.05).</p><p><strong>Conclusion: </strong>For irreducible trochanteric fractures with bisected lesser trochanters, the lateral decubitus position serves as an optimized surgical workflow and is associated with perioperative efficiency benefits over the supine traction table position, including significantly shortened operative time, reduced fluoroscopy use, and decreased blood loss.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"8 ","pages":"1853499"},"PeriodicalIF":4.6,"publicationDate":"2026-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13328492/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148393068","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Automated pneumatic tourniquet for hemorrhage control evaluated using an adaptive testing platform.","authors":"Theodore G Winter, Carlos Bedolla, Isiah M Mejia, James P Collier, Eric J Snider","doi":"10.3389/fmedt.2026.1844569","DOIUrl":"10.3389/fmedt.2026.1844569","url":null,"abstract":"<p><p>Hemorrhage remains a leading cause of preventable death in trauma situations with hemorrhage control being a critical first step to stabilizing injuries. Tourniquets are commonly used for this purpose, but they can adjust during transport leading to re-hemorrhage or tissue damage during prolonged use. Here, we explored control system approaches to automate tourniquet initial inflation and prolonged management. Different designs were compared and an approach was identified capable of hemorrhage control in under 40 s. Furthermore, automated control of the tourniquet successfully managed tourniquet loosening and overtightening situations that typical tourniquets could not manage. In summary, automated tourniquets have the potential to aid with hemorrhage control in early echelons of care while lessening the cognitive burden on limited medical personnel.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"8 ","pages":"1844569"},"PeriodicalIF":4.6,"publicationDate":"2026-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13318935/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148371261","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A stacked cavity-backed metamaterial antenna for confined hyperthermia of subcutaneous fat in ISM band.","authors":"Dong-Min Lee, Yun-Jae Jung, Ikhwan Kim, Kyujin Cho, Qingzhou Wang, Seongwoog Oh, Eun-Seong Kim, Nam-Young Kim","doi":"10.3389/fmedt.2026.1768771","DOIUrl":"10.3389/fmedt.2026.1768771","url":null,"abstract":"<p><strong>Introduction: </strong>Hyperthermia has emerged as a versatile modality in oncology, rehabilitation, and aesthetic medicine, yet conventional RF devices often suffer from insufficient penetration and collateral epidermal heating. This study proposes a miniaturized stacked cavity-backed antenna operating in the 2.4-2.5 GHz ISM band for depth-confined heating of facial subcutaneous fat.</p><p><strong>Methods: </strong>By leveraging the strong dielectric contrast at the skin-fat boundary, the design enhances the normal electric-field component in adipose tissue to promote preferential power deposition without active epidermal cooling. Electromagnetic simulations quantify field and SAR confinement, and multiphysics thermal simulations evaluate short-pulse therapeutic operation. The methodology is validated through ex vivo porcine experiments and a preliminary in vivo human feasibility test (10 W, surface thermography).</p><p><strong>Results: </strong>The results confirm reproducible superficial warming at the target depth without adverse skin reactions. The study successfully demonstrates single-element hardware feasibility and effective depth-selective energy confinement within the subcutaneous fat layer.</p><p><strong>Conclusion: </strong>This research establishes the fundamental hardware capability for targeted facial hyperthermia. However, macroscopic treatment-uniformity protocols and long-term clinical efficacy remain topics for future clinical studies.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"8 ","pages":"1768771"},"PeriodicalIF":4.6,"publicationDate":"2026-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13291053/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148335255","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of remote radar based vital sign acquisition for emergency department patient triage.","authors":"Yossi Shaya, Gil Levy, Akiva Esterson, Tommer Stein, Alon Kurtsman, Henry Czerniak, Itai Gordon, Keren Hod, Pinchas Halpern, Sagi Zimilis, Debra West, Daniel Trotzky, Ilan Bublil, Michael J Drescher","doi":"10.3389/fmedt.2026.1759641","DOIUrl":"10.3389/fmedt.2026.1759641","url":null,"abstract":"<p><strong>Introduction: </strong>To enable remote acquisition of patients' vital signs, ELTA Systems Ltd. developed a Radar remote vital signs acquisition system (TAMAR). The system identifies chest and neck respiratiory movements and pulse wave movements, enabling quantification of respiratory and pulse rates. The validation process of the TAMAR system is reported.</p><p><strong>Methods: </strong>A multicenter, prospective observational study was performed, enrolling low acuity patients who presented to 3 Emergency Departments. Patients provided consent and had their pulse and respiratory rates simultaneously measured by the TAMAR radar system and a traditional monitor (Mindray BeneVision N15). Vital signs were recorded continuously by both systems for 150 s, and later compared using Bland-Altman statistical analysis.</p><p><strong>Results: </strong>Between May and September 2021 we enrolled 315 patients. Measurements were calculated in 181/259 (70%) patients for Heart Rate (HR), and in 191/252 patients (76%) for Respiratory Rate (RR). For RR, the upper level of agreement (LOA) was 1.0, and the lower LOA was 1.6 respirations per minute. For HR, the upper level of agreement was 4.7, and the lower LOA was 3.5 beats per minute. All of these were well below the predetermined acceptable LOA of +/- 10 percent of the reference monitor rate.</p><p><strong>Discussion: </strong>The vital signs acquired by the TAMAR system, based on 90-second average measurements, are statistically adequate compared to traditional monitors, suggesting that TAMAR may replace traditional monitors for patients' triage.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"8 ","pages":"1759641"},"PeriodicalIF":4.6,"publicationDate":"2026-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13290987/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148335186","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Hospital efficiency assessment: a systematic review of DEA and hybrid DEA-machine learning approaches.","authors":"Nesrin Alkan, Ubeyde Kaan Koluk, Bilal Baris Alkan, Alper Sinan","doi":"10.3389/fmedt.2026.1820803","DOIUrl":"10.3389/fmedt.2026.1820803","url":null,"abstract":"<p><p>The increasing complexity of healthcare systems and growing resource constraints have made hospital efficiency assessment central to healthcare management and policy. Data Envelopment Analysis (DEA) has been widely used to evaluate hospital efficiency due to its ability to accommodate multiple input and output structures. However, classical DEA applications provide limited support for explaining efficiency scores, generating predictions, and informing managerial decision-making. This study systematically reviews hospital efficiency studies published between 2020 and 2025 to examine the use and limitations of DEA and to identify approaches integrating DEA with machine learning (ML). To more comprehensively demonstrate the methodological diversity of DEA-machine learning integration, studies from non-healthcare fields have also been included in the comparative analysis. Following PRISMA guidelines, standalone DEA and DEA-ML studies were analysed and coded across methodological dimensions. Multiple Correspondence Analysis was applied to identify dominant methodological configurations and emerging patterns in the literature. Findings indicate that CCR and BCC models remain prevalent, with human resources and financial indicators as common inputs and service delivery measures as outputs. DEA-ML research largely relies on two-stage structures focused on classification and prediction. The results highlight methodological gaps and the potential of more explainable and decision-support-oriented DEA-ML approaches to enhance benchmarking and resource allocation in hospital efficiency management.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"8 ","pages":"1820803"},"PeriodicalIF":4.6,"publicationDate":"2026-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13290754/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148335192","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}