Frontiers in medical technology最新文献

{"title":"Regulatory landscape of accelerated approval pathways for medical devices in the United States and the European Union.","authors":"Tanvi Gupte, Tushar Nitave, Jogarao Gobburu","doi":"10.3389/fmedt.2025.1586070","DOIUrl":"10.3389/fmedt.2025.1586070","url":null,"abstract":"<p><p>The landscape of medical device regulation is rapidly evolving, driven by innovations and the need to bring these technologies to patients more efficiently. This review provides a comprehensive analysis of the accelerated access pathways for medical devices in the United States (US) and the European Union (EU), focusing on the Breakthrough Devices Program (BDP) in the US and the evolving regulatory framework within the EU. Analysis of Food and Drug Administration (FDA) data reveals that from 2015 to 2024, only 12.3% of the 1,041 BDP-designated devices received marketing authorization, with mean decision times of 152, 262, and 230 days for 510(k), <i>de novo</i>, and PMA pathways respectively-significantly faster than standard approvals for <i>de novo</i> (338 days) and PMA (399 days). In the EU, where no specific accelerated pathway exists, the recently implemented Medical Device Regulation and Health Technology Assessment Regulation aim to harmonize approval processes, with joint clinical assessments beginning in 2026. The analysis explores the interplay between regulatory approval, funding mechanisms, and coverage policies that collectively determine the accessibility of medical devices. The unique challenges associated with emerging technologies and the implementation of accelerated pathways are also discussed. We recommend global regulatory convergence through harmonized standards, mutual recognition agreements, and unified post-market surveillance systems to balance innovation with patient safety.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"7 ","pages":"1586070"},"PeriodicalIF":2.7,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12119601/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144183150","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":"Comparative evaluation of accuracy, precision, and radiation dose between mindways and low-dose iCare QCT for lumbar spine BMD using the European spine phantom.","authors":"Yujie Li, Tiantian Yin, Qiushi Yang, Heli Han, Zeguo Wang, Wanjiang Yu","doi":"10.3389/fmedt.2025.1575553","DOIUrl":"10.3389/fmedt.2025.1575553","url":null,"abstract":"<p><strong>Background: </strong>Quantitative computed tomography (QCT) has received growing attention for its utility in bone mineral density (BMD) assessment and osteoporosis diagnosis.</p><p><strong>Objective: </strong>To assess the accuracy and precision of lumbar spine BMD measurements obtained using low-dose iCare QCT, based on the European Spine Phantom (ESP).</p><p><strong>Methods: </strong>Paired <i>t</i>-test was employed to compare BMD values measured under normal-dose and low-dose scan protocols using Mindways and iCare QCT systems. Accuracy was evaluated using relative measurement error (RME), and precision was assessed via relative standard deviation (RSD). Pearson correlation coefficients and Bland-Altman analysis were used to examine measurement correlation and agreement.</p><p><strong>Results: </strong>For Mindways QCT, RMEs of L1-L3 were 11.89%, 6.94%, and 6.72% under normal-dose, and 6.65%, 10.5%, and 6.31% under low-dose, respectively. For iCare QCT, RMEs were 1.21%, 4.28%, and 8.88% under normal-dose, and 2.14%, 4.96%, and 8.59% under low-dose, respectively. RSDs of L1-L3 for Mindways QCT were 5.16%, 2.85%, and 0.47% under normal-dose, and 9.08%, 4.69%, and 0.49% under low-dose, respectively. For iCare QCT, RSDs were 1.11%, 0.81%, and 0.45% under normal-dose, and 2.34%, 0.85%, and 0.33% under low-dose, respectively. The radiation dose in the low-dose protocol was significantly reduced compared with the normal-dose protocol.</p><p><strong>Conclusion: </strong>Low-dose iCare QCT exhibited high accuracy and precision in measuring lumbar spine BMD, achieving an approximately 85% reduction in radiation dose. These findings highlight its potential as a safer and reliable tool for clinical application.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"7 ","pages":"1575553"},"PeriodicalIF":2.7,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12107097/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144164278","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":"Regulatory aspects of optogenetic research and therapy for retinitis pigmentosa under EU law.","authors":"Johannes Freise","doi":"10.3389/fmedt.2025.1548927","DOIUrl":"10.3389/fmedt.2025.1548927","url":null,"abstract":"<p><p>Optogenetics has potentials for a treatment of retinitis pigmentosa and other rare degenerative retinal diseases. The technology allows controlling cell activity through combining genetic engineering and optical stimulation with light. First clinical studies are already being conducted, whereby the vision of participating patients who were blinded by retinitis pigmentosa was partially recovered. In view of the ongoing translational process, this paper examines regulatory aspects of preclinical and clinical research as well as a therapeutic application of optogenetics in ophthalmology. There is no prohibition or specific regulation of optogenetic methods in the European Union. Regarding preclinical research, legal issues related to animal research and stem cell research have importance. In clinical research and therapeutic applications, aspects of subjects' and patients' autonomy are relevant. Because at EU level, so far, no specific regulation exists for clinical studies in which a medicinal product and a medical device are evaluated simultaneously (combined studies) the requirements for clinical trials with medicinal products as well as those for clinical investigations on medical devices apply. This raises unresolved legal issues and is the case for optogenetic clinical studies, when for the gene transfer a viral vector classified as gene therapy medicinal product (GTMP) and for the light stimulation a device qualified as medical device are tested simultaneously. Medicinal products for optogenetic therapies of retinitis pigmentosa fulfill requirements for designation as orphan medicinal product, which goes along with regulatory and financial incentives. However, equivalent regulation does not exist for medical devices for rare diseases.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"7 ","pages":"1548927"},"PeriodicalIF":2.7,"publicationDate":"2025-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12098278/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144145123","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":"Drug coated balloons in percutaneous coronary intervention: how can computational modelling help inform evolving clinical practice?","authors":"Silvia Renon, Rafic Ramses, Ankush Aggarwal, Richard Good, Sean McGinty","doi":"10.3389/fmedt.2025.1546417","DOIUrl":"https://doi.org/10.3389/fmedt.2025.1546417","url":null,"abstract":"<p><p>Drug-coated balloons (DCB) represent an emerging therapeutic alternative to drug-eluting stents (DES) for the treatment of coronary artery disease (CAD). Among the key advantages of DCB over DES are the absence of a permanent structure in the vessel and the potential for fast and homogeneous drug delivery. While DCB were first introduced for treatment of in-stent restenosis (ISR), their potential wider use in percutaneous coronary intervention (PCI) has recently been explored in several randomized clinical trials, including for treatment of <i>de novo</i> lesions. Moreover, new hybrid techniques that combine DES and DCB are being investigated to more effectively tackle complex cases. Despite the growing interest in DCB within the clinical community, the mechanisms of drug exchange and the interactions between the balloon, the polymeric coating and the vessel wall are yet to be fully understood. It is, therefore, perhaps surprising that the number of computational (<i>in silico</i>) models developed to study interventions involving these devices is small, especially given the mechanistic understanding that has been gained from computational studies of DES procedures over the last two decades. In this paper, we discuss the current and emerging clinical approaches for DCB use in PCI and review the computational models that have been developed thus far, underlining the potential challenges and opportunities in integrating <i>in silico</i> models of DCB into clinical practice.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"7 ","pages":"1546417"},"PeriodicalIF":2.7,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12075205/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144083027","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":"Molecular diagnostic methods for rapid diagnosis of central nervous system infections.","authors":"Mallikarjuna Pedduru Venkatareddy, Dinesh Upadhya, Prakash Peralam Yegneswaran, Aneena Varghese, Suryadipali Pahadasingh, Arvind N Prabhu, Kavitha Saravu, Kavitha S Shettigar","doi":"10.3389/fmedt.2025.1497512","DOIUrl":"10.3389/fmedt.2025.1497512","url":null,"abstract":"<p><p>Central nervous system infections (CNSI) are serious life-threatening conditions caused by bacteria, viruses, fungi, and parasites and lead to high morbidity and mortality worldwide. Therefore, rapid identification of causative organisms and appropriate treatment are important. The traditional identification methods are time-consuming and lack sensitivity and specificity. Although culture method is gold standard for CNSI, it is time-consuming and microbiology reporting requires several days. Multiplex PCR assays can detect multiple pathogens simultaneously in clinical samples and overcome the limitations of conventional identification techniques. Despite the availability of several commercial molecular-based platforms for the detection of pathogens causing CNSI, there are still limitations in terms of cost, false positive results, and false negative results, which are limited to targeted pathogens in the panel. Moreover, validation of many commercially available and in-house laboratory-developed molecular assays is still lacking. In addition, molecular diagnostic tests need to be used in correlation with the clinical context to ensure better diagnosis and management of infections.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"7 ","pages":"1497512"},"PeriodicalIF":2.7,"publicationDate":"2025-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12093496/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144121806","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":"Advanced computational tools, artificial intelligence and machine-learning approaches in gut microbiota and biomarker identification.","authors":"Tikam Chand Dakal, Caiming Xu, Abhishek Kumar","doi":"10.3389/fmedt.2024.1434799","DOIUrl":"https://doi.org/10.3389/fmedt.2024.1434799","url":null,"abstract":"<p><p>The microbiome of the gut is a complex ecosystem that contains a wide variety of microbial species and functional capabilities. The microbiome has a significant impact on health and disease by affecting endocrinology, physiology, and neurology. It can change the progression of certain diseases and enhance treatment responses and tolerance. The gut microbiota plays a pivotal role in human health, influencing a wide range of physiological processes. Recent advances in computational tools and artificial intelligence (AI) have revolutionized the study of gut microbiota, enabling the identification of biomarkers that are critical for diagnosing and treating various diseases. This review hunts through the cutting-edge computational methodologies that integrate multi-omics data-such as metagenomics, metaproteomics, and metabolomics-providing a comprehensive understanding of the gut microbiome's composition and function. Additionally, machine learning (ML) approaches, including deep learning and network-based methods, are explored for their ability to uncover complex patterns within microbiome data, offering unprecedented insights into microbial interactions and their link to host health. By highlighting the synergy between traditional bioinformatics tools and advanced AI techniques, this review underscores the potential of these approaches in enhancing biomarker discovery and developing personalized therapeutic strategies. The convergence of computational advancements and microbiome research marks a significant step forward in precision medicine, paving the way for novel diagnostics and treatments tailored to individual microbiome profiles. Investigators have the ability to discover connections between the composition of microorganisms, the expression of genes, and the profiles of metabolites. Individual reactions to medicines that target gut microbes can be predicted by models driven by artificial intelligence. It is possible to obtain personalized and precision medicine by first gaining an understanding of the impact that the gut microbiota has on the development of disease. The application of machine learning allows for the customization of treatments to the specific microbial environment of an individual.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"6 ","pages":"1434799"},"PeriodicalIF":2.7,"publicationDate":"2025-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12037385/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144000787","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":"Drilling around the corner: a comprehensive literature review of steerable bone drills.","authors":"Esther P de Kater, Paul Breedveld, Aimée Sakes","doi":"10.3389/fmedt.2025.1426858","DOIUrl":"https://doi.org/10.3389/fmedt.2025.1426858","url":null,"abstract":"<p><strong>Introduction: </strong>Orthopedic procedures often require drilling of tunnels through bone, for instance for the introduction of implants. The currently used rigid bone drills make it challenging to reach all target areas without damaging surrounding anatomy. Steerable bone drills are a promising solution as they enable access to larger volumes and the creation of curved tunnels thereby reducing the risk of harm to surrounding anatomical structures.</p><p><strong>Method: </strong>This review provides a comprehensive overview of steerable bone drill designs identified in patent literature via the Espacenet database and in scientific literature accessed via the Scopus data base. A Boolean search combined with pre-set inclusion criteria returned 78 literature references describing a variety of drill designs.</p><p><strong>Results: </strong>These drill designs could be categorized based on how the drilling trajectory was defined. Three methods to influence the drilling trajectory were identified: (1) the device (57% of the sources), (2) the environment (15% of the sources): the path is defined based on the tissue interaction forces with the surrounding bone or (3) the user defines the drilling trajectory (28% of the sources).</p><p><strong>Discussion: </strong>The comprehensive overview of steerable drilling methods provides insights in the possibilities in drill design and may be used as a source of inspiration for the design of novel steerable drill designs.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"7 ","pages":"1426858"},"PeriodicalIF":2.7,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12016042/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144028362","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 fully integrated whole-head helium OPM MEG: a performance assessment compared to cryogenic MEG.","authors":"Maxime Bonnet, Denis Schwartz, Tjerk Gutteling, Sebastien Daligault, Etienne Labyt","doi":"10.3389/fmedt.2025.1548260","DOIUrl":"https://doi.org/10.3389/fmedt.2025.1548260","url":null,"abstract":"<p><p>Magnetoencephalography (MEG) is a neuroimaging technique that measures neuronal activity at a millisecond scale. A few years ago, a new generation of MEG sensors emerged: optically pumped magnetometers (OPMs). The most common OPMs use alkali atoms as the sensing element. These alkali OPM sensors must be heated to approximately 150°C, in contrast to classical MEG sensors [superconducting quantum interference device MEG], which need to be cooled down to -269°C. This article focuses on a new kind of OPM that uses Helium-4 gas as the sensing element, which solves some disadvantages of alkali OPMs. ⁴He-OPM sensors operate at room temperature, with negligible heat dissipation (10 mW) and thus do not need thermal insulation. They also offer a large dynamic range (±200 nT) and frequency bandwidth (2,000 Hz). The main goal of this study is to characterize the performance of a whole-head MEG system based on ⁴He OPM sensors (⁴He OPM MEG). We first simulated different sensor configurations with three different numbers of channels and three different head sizes, from child to adult, in order to assess the signal-to-noise ratio and the source reconstruction accuracy. Experimental testing was also performed using a phantom to simulate brain magnetic activity. The simulation and experiments show equivalent detection capability and localization accuracy on both MEG systems. These results illustrate the benefit of ⁴He OPM sensors that operate at room temperature and are positioned closer to the scalp.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"7 ","pages":"1548260"},"PeriodicalIF":2.7,"publicationDate":"2025-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12006120/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144056022","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":"Evaluation of different safety-engineered protection mechanisms of port access needles using a lifelike model of vascular access routes.","authors":"Feline Gabler, Pierre Heiden, Peter Deibert, Daniel Steinmann","doi":"10.3389/fmedt.2025.1505184","DOIUrl":"https://doi.org/10.3389/fmedt.2025.1505184","url":null,"abstract":"<p><strong>Background: </strong>Preventing needlestick injuries caused by hypodermic needles is crucial for healthcare personnel. In this context, port access needles play an important role. However, systematic comparisons of different safety-engineered port access needles have not been conducted. Therefore, we evaluated differences in product characteristics and user preferences of safety-engineered protection mechanisms of port access needles.</p><p><strong>Methods: </strong>Port puncture was performed using port access needles with four different safety mechanisms: (a) EZ Huber™ PFM Medical, (b) Gripstick® Safety OMT, (c) Gripper Micro® Smiths Medical and (d) pps ct® Vygon. Each needle type was used in three consecutive tries: an uninstructed first handling, after which instructions were given according to operating manual. Subsequently, a first and second trial were conducted. Study endpoints included successful activation, activation time, way of activation (one hand or two hands), correct activation, possible risk of needlestick injury, possibility of deactivation and preferred safety mechanism.</p><p><strong>Results: </strong>Overall, successful activation rate during the second trial was equal for all four devices (100%). Median activation time was (a) 6 s, (b) 3 s, (c) 11 s and (d) 6 s. Single-handed activation during the second trial was (a) 0%, (b) 75%, (c) 1% and (d) 1%. Single-handed activation after further preparation with two hands during the second trial was (a) 0%, (b) 0%, (c) 0% and (d) 50%. Correct activation during the second trial was (a) 97%, (b) 66%, (c) 19% and (d) 44%. Possible risk of needlestick injury during the second trial was highest with (b). Possibility of deactivation was (a) 75%, (b) 94%, (c) 97% and (d) 22%. Individual preferences for each system were (a) <i>n</i> = 5, (b) <i>n</i> = 2, (c) <i>n</i> = 1 and (d) <i>n</i> = 24. The main written reasons given for preference were the safety protection mechanism and handling of the port needle.</p><p><strong>Conclusion: </strong>We have shown significant differences regarding product characteristics of safety mechanisms of port access needles. Our evaluation approach provides specific data for both, technical (e.g., single-handed activation) and personal device selection criteria (e.g., preference of the safety mechanism).</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"7 ","pages":"1505184"},"PeriodicalIF":2.7,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12003311/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144038905","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 low-cost platform for automated cervical cytology: addressing health and socioeconomic challenges in low-resource settings.","authors":"José Ocampo-López-Escalera, Héctor Ochoa-Díaz-López, Xariss M Sánchez-Chino, César A Irecta-Nájera, Saúl D Tobar-Alas, Martha Rosete-Aguilar","doi":"10.3389/fmedt.2025.1531817","DOIUrl":"https://doi.org/10.3389/fmedt.2025.1531817","url":null,"abstract":"<p><strong>Introduction: </strong>Cervical cancer remains a significant health challenge around the globe, with particularly high prevalence in low- and middle-income countries. This disease is preventable and curable if detected in early stages, making regular screening critically important. Cervical cytology, the most widely used screening method, has proven highly effective in reducing cervical cancer incidence and mortality in high income countries. However, its effectiveness in low-resource settings has been limited, among other factors, by insufficient diagnostic infrastructure and a shortage of trained healthcare personnel.</p><p><strong>Methods: </strong>This paper introduces the development of a low-cost microscopy platform designed to address these limitations by enabling automatic reading of cervical cytology slides. The system features a robotized microscope capable of slide scanning, autofocus, and digital image capture, while supporting the integration of artificial intelligence (AI) algorithms. All at a production cost below 500 USD. A dataset of nearly 2,000 images, captured with the custom-built microscope and covering seven distinct cervical cellular types relevant in cytologic analysis, was created. This dataset was then used to fine-tune and test several pre-trained models for classifying between images containing normal and abnormal cell subtypes.</p><p><strong>Results: </strong>Most of the tested models showed good performance for properly classifying images containing abnormal and normal cervical cells, with sensitivities above 90%. Among these models, MobileNet demonstrated the highest accuracy in detecting abnormal cell types, achieving sensitivities of 98.26% and 97.95%, specificities of 88.91% and 88.72%, and F-scores of 96.42% and 96.23% on the validation and test sets, respectively.</p><p><strong>Conclusions: </strong>The results indicate that MobileNet might be a suitable model for real-world deployment on the low-cost platform, offering high precision and efficiency in classifying cervical cytology images. This system presents a first step towards a promising solution for improving cervical cancer screening in low-resource settings.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"7 ","pages":"1531817"},"PeriodicalIF":2.7,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11994738/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144034646","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}