Medical Devices-Evidence and Research最新文献

{"title":"Malfunctions and Management of Home Medical Equipment in Visiting Nursing Stations and Collaboration with Clinical Engineers.","authors":"Shuichi Hamasaka, Kaoru Kyota, Satoko Mizohata, Keiko Tsukasaki","doi":"10.2147/MDER.S598103","DOIUrl":"https://doi.org/10.2147/MDER.S598103","url":null,"abstract":"<p><strong>Background: </strong>Home medical equipment is extensively utilized in Japan; however, its management is typically overseen by visiting nurses or medical equipment manufacturers rather than by clinical engineers (CEs), who are specialized professionals. Visiting nurses often lack expertise in medical equipment, and manufacturers face legal limitations regarding equipment management. Improper operation or maintenance threatens patient safety. This study aims to elucidate the relationship between equipment malfunctions and management practices at visiting nursing stations (stations), as well as to assess the perceived need for CEs.</p><p><strong>Methods: </strong>A nationwide cross-sectional questionnaire survey was conducted, in which a stratified random sample of 500 stations was selected nationwide by region, with 76 stations providing valid responses. A questionnaire survey was conducted to assess the incidence and management of malfunctions across six types of medical equipment: infusion pumps, syringe pumps, electric suction units, oxygen concentrators, non-invasive positive pressure ventilation devices, and tracheostomy positive pressure ventilation devices. The survey also evaluated the perceived necessity for CEs. Associations between equipment malfunctions and management practices were analyzed using the chi-square or Fisher's exact tests.</p><p><strong>Results: </strong>Among the 76 stations, device abnormalities were the most frequently reported cause of malfunctions across all six equipment types, accounting for over half of the cases. In more than half of the incidents, responses were managed by visiting nurses and manufacturers. Significant associations were identified between infusion pump malfunctions and hospital affiliation, as well as between syringe pump malfunctions and the presence of operation manuals and safety information collection. Notably, 81.6% of stations recognized the need for CEs in home medical care.</p><p><strong>Conclusion: </strong>This study elucidated the relationship between equipment malfunctions, management practices at stations, and the perceived need for CEs. Our findings highlight the importance of establishing a collaborative framework between stations and CEs.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"598103"},"PeriodicalIF":1.5,"publicationDate":"2026-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13148265/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147844380","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":"Dynamic Changes in Exhaled Breath Glucose by Condensate Collection During Oral Glucose Tolerance Testing in Healthy Adults.","authors":"Wen Xu, Qingping Zhang, Yilian Hong, Zhenjun Mao","doi":"10.2147/MDER.S568279","DOIUrl":"https://doi.org/10.2147/MDER.S568279","url":null,"abstract":"<p><strong>Purpose: </strong>Invasive blood glucose monitoring is associated with pain and suboptimal patient adherence, creating a need for non-invasive alternatives. In this study, we investigated the dynamic relationship between glucose levels in exhaled breath and blood during an oral glucose tolerance test (OGTT) in healthy adults, to assess the feasibility of using exhaled breath glucose as a non-invasive marker for glycemic monitoring.</p><p><strong>Methods: </strong>Twenty healthy volunteers (12 males, 8 females; mean age 23.1 ± 2.4 years) underwent a standardized OGTT test. Exhaled breath condensate (EBC) and blood samples were collected simultaneously at fasting (0h) and at 0.5h, 1h, 2h, and 3h post-glucose load. EBC glucose concentration was measured using ion chromatography. The temporal profiles of both parameters were analyzed, and the correlation between the rate of change in exhaled breath glucose and blood glucose at each time point was assessed using Pearson or Spearman correlation test.</p><p><strong>Results: </strong>Both blood glucose and exhaled breath glucose exhibited similar temporal patterns, peaking within 0.5-1 h after glucose administration and returning to baseline by 3h. Exhaled breath glucose increased from a fasting level of 0.49 ± 0.11 ng/L to a peak of 4.07 ± 1.44 ng/L at 1h. A statistically significant positive correlation between the rate of change in exhaled breath glucose and blood glucose was observed at 1h (<i>r</i> = 0.84, <i>p</i> < 0.000), whereas the correlation at 0.5h was not significant after correction for multiple comparisons (<i>ρ</i> = 0.45, adjusted <i>p</i> = 0.196). No significant correlations were detected at 2h or 3h. The changes in exhaled breath glucose were not associated with baseline pulmonary function-as measured by forced vital capacity (<i>p</i> > 0.05).</p><p><strong>Conclusion: </strong>Exhaled breath glucose levels dynamically track blood glucose changes during the early postprandial phase in healthy adults, demonstrating strong concordance during periods of rapid glycemic excursion. These findings support the feasibility of EBC as a non-invasive tool for monitoring glycemic trends. Further validation in larger cohorts and diabetic patients is required to establish its clinical utility.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"568279"},"PeriodicalIF":1.5,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13142279/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147844384","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":"Female Supine Urination Tech: Patent Landscape & Indicators.","authors":"Ana Mesa La Guardia, Maria Teresa Prats Valls, Mónica Micó Cabedo, Nuria Domenech Climent, Pablo Juan Verdoy, Jaume Gual Ortí","doi":"10.2147/MDER.S584153","DOIUrl":"https://doi.org/10.2147/MDER.S584153","url":null,"abstract":"<p><strong>Purpose: </strong>Female urination in the supine position is a frequent bedside need, yet common workarounds (bedpans, diapers, improvised receptacles) can be uncomfortable, increase caregiver workload, and contribute to potentially avoidable urinary catheterization. We mapped the patent landscape of non-invasive female urine-collection technologies intended for supine use and derived actionable innovation and access priorities.</p><p><strong>Methods: </strong>We searched Espacenet (EPO), WIPO PATENTSCOPE, the USPTO database, Google Patents, and INVENES for January 2000-September 2025. Records were screened for functional relevance to female supine voiding and de-duplicated at the DOCDB family level. For each patent family we extracted priority/publication timing, jurisdictions, assignees, IPC/CPC codes, and forward citations; coded solution archetypes; and coded adoption-relevant attributes (workflow feasibility, infrastructure dependence, and single-use vs reusable design intent). A structured multi-domain appraisal (0-2 per domain; total 0-12) was applied to representative families to support consistent comparison.</p><p><strong>Results: </strong>Twenty-six patent families met inclusion criteria. Innovation activity was sustained but low-intensity and uneven over time, with most filings clustered in 2010-2020; interpretation of late years was limited by publication lag. Most inventions followed single-use/disposable pathways (≈69%). The set covered 16 IPC subclasses, although >60% of families were concentrated in A61F 5/455. Passive external collectors showed the strongest maturity signals. Adhesive patch-type and intravaginal concepts were sporadic and heterogeneous. Suction/capillary approaches introduced stronger containment mechanisms but increased dependence on external infrastructure and proprietary consumables, limiting feasibility in home care and low-resource settings.</p><p><strong>Conclusion: </strong>The most consistent gap lies at the intersection of ergonomics, autonomy, and reusability-female-specific supine interfaces that contain leakage without adhesives or invasive elements, operate passively or with minimal infrastructure, and enable sterilizable/reusable pathways. Priorities for R&D include usability- and risk-informed evaluation, sustainability-by-design, and access-oriented IP strategies to support diffusion beyond high-resource settings.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"584153"},"PeriodicalIF":1.5,"publicationDate":"2026-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13110041/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147785477","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":"Optimizing Respiratory Care with NEXThaler: Bridging Technology and Treatment.","authors":"Omar Usmani, Fulvio Braido, Daiana Stolz, Anh Tuan Dinh-Xuan, Borja G Cosio, Laura Franzini, Alessio Piraino, Ulrica Scaffidi Argentina","doi":"10.2147/MDER.S577725","DOIUrl":"https://doi.org/10.2147/MDER.S577725","url":null,"abstract":"<p><p>Inhaled therapy is central in the management of asthma and chronic obstructive pulmonary disease, with inhaler device selection significantly influencing treatment efficacy and patient adherence. NEXThaler is a breath-actuated dry powder inhaler (DPI) designed to deliver extrafine formulations of inhaled corticosteroids (ICS) and bronchodilators, ensuring consistent drug deposition across both central and peripheral airways. This review provides a clinically oriented overview of inhaler technologies, focusing on the design features and clinical performance of this breath-actuated DPI. Notably, this narrative review is based on a comprehensive analysis of peer-reviewed clinical and preclinical studies on the NEXThaler DPI. Most evidence presented is derived from non-comparative studies, modeling approaches, or sponsor-supported trials. Key features of the NEXThaler DPI include a breath-actuated mechanism, flow-independent dosing, a dose counter and a triple feedback system that enhances correct usage, and a simplified open-inhale-close mechanism. The delivery of extrafine particles (<2 µm) facilitates deeper lung penetration, improving small airway targeting and potentially allowing for lower ICS doses with maintained efficacy. Lung deposition studies demonstrate superior peripheral distribution and consistent dosing across varying inspiratory flow rates. Clinical trials and real-world studies confirm the efficacy and safety of bronchodilators and ICS combinations delivered via the NEXThaler DPI in both asthma and chronic obstructive pulmonary disease populations, showing noninferiority to pressurized metered-dose inhalers and improved outcomes in lung function, symptom control, and adherence. The device's usability and patient satisfaction further support its role in respiratory care. Additionally, its propellant-free design contributes to reducing the environmental impact of inhaler therapy. Overall, thanks to its technological innovations, the NEXThaler DPI represents a clinically validated and patient-friendly option for the delivery of inhaled therapies in chronic respiratory diseases.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"577725"},"PeriodicalIF":1.5,"publicationDate":"2026-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13070343/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147677729","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 Multidimensional Index Framework for Evaluating the Regulatory Applicability of ISO 10328 Using a Prosthetic Knee Case Study.","authors":"Jia Li","doi":"10.2147/MDER.S558998","DOIUrl":"https://doi.org/10.2147/MDER.S558998","url":null,"abstract":"<p><p>International biomechanical standards, such as ISO 10328 for lower-limb prosthetic testing, are widely used to guide device evaluation, yet their direct adoption into national regulatory systems often results in mismatches in safety expectations, documentation formats, and contextual use conditions. Despite extensive reliance on ISO standards, there is no structured method to assess whether these standards are appropriately aligned with regulatory requirements across different jurisdictions. This narrative review, combined with a conceptual framework and an illustrative cross-jurisdictional case study, proposes a multi-dimensional applicability index designed to evaluate the regulatory fit of international biomechanical standards before national adoption. The index comprises five dimensions clinical safety alignment, technical fit, contextual usability, documentation conformance, and regulatory interoperability, each providing a structured lens for assessing standard suitability. Using ISO 10328 and a representative prosthetic knee device as an example, the study demonstrates how the index highlights areas of strong technical alignment but also reveals gaps related to usability, documentation, and post-market expectations across the U.S. FDA, EU MDR, and China's GB/NMPA systems. The findings underscore the need for context-aware evaluation tools to complement global standards, reducing approval delays and improving device performance in real-world environments. This work provides a foundational methodology for regulators, manufacturers, and standards bodies seeking to harmonize global testing norms while ensuring national regulatory relevance and patient safety.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"558998"},"PeriodicalIF":1.5,"publicationDate":"2026-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13038417/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147610268","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":"Design and Research of Multi Segment Exoskeleton Reconfigurable Soft Finger Actuator.","authors":"Zhilin Zhang, Aldrin D Calderon, Junliang Lai, Helin Wang, Xianhao Hu, Daonan Chen, Chuanjian Liang","doi":"10.2147/MDER.S476462","DOIUrl":"10.2147/MDER.S476462","url":null,"abstract":"<p><strong>Purpose: </strong>The growing number of patients with hand dysfunction caused by conditions such as stroke has led to increasing demand for soft finger rehabilitation actuators. However, existing devices of this type often face issues such as irregular deformation, insufficient driving force, the inability to achieve segmented control, and poor rigidity retention.</p><p><strong>Methods: </strong>A multi-segment exoskeleton design is proposed, which achieves a functional separation between actuation and load-bearing. Utilizing the principle of virtual work and the Yeoh constitutive model, derive the pressure-to-angle transfer function to facilitate the establishment of the overall equation of motion.</p><p><strong>Results: </strong>The finite element analysis and experimental tests conducted in this study prove that the design prevents irregular deformation, enables segmented control, and maintains high rigidity. Through physical testing, a maximum bending angle of 338.7° and a maximum driving force of 11.50 N were achieved, which is 25.27% higher than the 9.18 N force found in existing studies.</p><p><strong>Conclusion: </strong>The multi-segment reconfigurable soft finger exoskeleton actuator proposed in this study demonstrates significant advantages over conventional devices, with its enhanced bending range and force output facilitating patients' performance of daily grasping tasks. The segmented control capability enables personalized rehabilitation training targeting specific finger joints. This innovation holds substantial promise for improving hand function recovery in stroke patients.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"476462"},"PeriodicalIF":1.5,"publicationDate":"2026-03-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13025834/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147575771","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":"Quantifying Changes in Balance, Gait, Fall Risk, and Sensory Reweighting in Older Adults Following Multi-Session Electrical Vestibular Stimulation Therapy.","authors":"John D Ralston, Scott Stanley, Joshua M Roper, Osman Darici, Ryan M Peters","doi":"10.2147/MDER.S590344","DOIUrl":"10.2147/MDER.S590344","url":null,"abstract":"<p><strong>Objective: </strong>To assess the utility of digital biomarkers derived from a head-mounted wearable physiological vibration acceleration (phybrata) sensor for quantifying changes in balance, gait, fall risk, and sensory reweighting in older adults undergoing multi-session electrical vestibular stimulation therapy (eVST).</p><p><strong>Methods: </strong>Data were collected and analyzed from 32 residents aged 60-98 yrs from a continuing care retirement community before, during, and after the administration of an 18-session eVST treatment protocol delivered over a 4-6-week period. Each session included subthreshold wideband stochastic electrical vestibular stimulation (swsEVS) for 20 minutes delivered using a wearable device. Balance performance, sensory reweighting, and fall risk were assessed immediately before and after treatment using a head-mounted phybrata sensor. Two additional standard balance tests, along with wearable-sensor-based gait assessments, were administered before the 1^st and after the 18^th treatment session.</p><p><strong>Results: </strong>30 of the 32 participants demonstrated significantly improved balance and gait performance and reduced fall risk following the 18-session eVST treatment protocol. Phybrata sensory reweighting profiles for the study participants as a group revealed significant recovery of vestibular balance regulation and decreased reliance on proprioception. Phybrata biomarkers were found to identify the 2 non-responders in the study population within the first 2 treatment sessions. The number of participants classified as \"high fall risk\" decreased from 19 to 4 following treatment. Significant stabilization of head movement was observed following eVST treatment using head-mounted sensors during gait tests over distances as short as 7.6m, with the largest reductions observed in the medial-lateral direction. Head-acceleration based gait biomarkers were found to be more sensitive to eVST-induced improvements than stride-to-stride gait parameters measured using foot-mounted sensors.</p><p><strong>Conclusion: </strong>Phybrata digital biomarkers enable rapid objective assessment of changes in balance, gait, fall risk, and sensory reweighting in older adults before, during, and after a multi-session eVST treatment protocol.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"590344"},"PeriodicalIF":1.5,"publicationDate":"2026-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13015830/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147522264","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":"Prospective Multicenter Evaluation of Patient Satisfaction and Radiologist Image Interpretation Using the Envision™ Mammography Platform.","authors":"Chirag R Parghi, Paul J Niklewski, Alexis Cooper, Muhammad Waqas","doi":"10.2147/MDER.S560551","DOIUrl":"10.2147/MDER.S560551","url":null,"abstract":"<p><strong>Purpose: </strong>Improving image quality without increasing patient discomfort remains a challenge in mammography. This study evaluated the ability of the Envision™ platform in a prospective, multicenter observational case-collection study (NCT05199701), focusing on patient comfort and radiologist-assessed image quality.</p><p><strong>Patients and methods: </strong>Across nine US breast-imaging sites, 929 women aged ≥35 years undergoing a clinically indicated screening or diagnostic mammogram, or a mammogram in the context of a recommended biopsy, were enrolled. All subjects received a standard four-view bilateral exam (RCC, RMLO, LCC, LMLO) on the Envision platform. Radiologists rated image quality (positioning, contrast, sharpness, tissue visibility, noise, artifacts, and overall clinical image quality) using a three-category scale (<i>requires reimaging, acceptable, excellent</i>). Patient comfort and device preference were assessed via questionnaire. Analyses were descriptive.</p><p><strong>Results: </strong>Most subjects (79%) preferred the investigational mammogram over prior mammograms, and 70% reported greater compression comfort. Discomfort scores were low: 34% reported no discomfort (0/10) and 52.5% reported minimal discomfort (1-2/10). Radiologists rated the majority of images acceptable or excellent, with excellent ratings of 41.9-48.5% for contrast, 41.8-42.0% for sharpness, 50.2-50.5% for tissue visibility, and 33.4-34.5% for artifacts. Repeat-imaging recommendations were infrequent (0-6.6% across views), and overall clinical image quality was acceptable or excellent in 94.1-100% of images.</p><p><strong>Conclusion: </strong>The Envision platform produced consistently high levels of clinically acceptable image quality while maintaining or improving patient comfort compared to prior mammography experiences. These findings support its feasibility for routine clinical use.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"560551"},"PeriodicalIF":1.5,"publicationDate":"2026-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13019162/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147575806","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":"Inter- and Intrarater Reliability of a Novel Ultrasound Doppler Device (earlybird) for Quantitative Assessment of Peripheral Arterial Flow.","authors":"Marie Tryland Høiberg, Stine Marie Pauschert Kvamme, Steffen Felle Bentsen, Karoline Løkken, Gudrun Rohde, Hans Torp, Arne Seternes, Erik Mulder Pettersen","doi":"10.2147/MDER.S579251","DOIUrl":"10.2147/MDER.S579251","url":null,"abstract":"<p><strong>Objective: </strong>Growing interest in quantitative Doppler assessment has underscored the need for reliable, operator-independent tools to evaluate peripheral arterial circulation. This study aimed to evaluate the reliability of a novel ultrasound Doppler device (earlybird) for measuring blood-flow velocity in lower-extremity arteries and to validate its consistency across raters. We further explored multiple hemodynamic parameters derived from the Doppler spectrogram to examine their reproducibility and potential clinical applicability.</p><p><strong>Methods: </strong>Thirty-five participants, including 25 with varying degrees of peripheral arterial disease (PAD) and 10 healthy individuals, were recruited. Four raters performed independent measurements of the peripheral blood-flow velocity in each participant (280 measurements). Six blood-flow parameters were extracted from the Doppler spectrograms: peak systolic velocity (PSV), time-averaged velocity (TAV), end-diastolic velocity (EDV), pulsatility index (PI), resistive index (RI), and acceleration time (AT). The intraclass correlation coefficient (ICC) was used to assess reliability, which was visualized in scatter plots and Bland-Altman plots with 95% limits of agreement.</p><p><strong>Results: </strong>Good correlation and agreement among the different raters were observed, with inter-rater reliability ranging from an ICC of 0.755-0.835 (<i>p</i> < 0.001). Intra-rater reliability showed poor to excellent correlation, with ICCs ranging from 0.450 to 0.961, (<i>p</i> < 0.001). Bland-Altman plots revealed wide 95% limits of agreement for PSV, TAV, EDV, and PI, but narrower limits for RI (-9.8% to 9.8%) and AT (-17.3% to 17.1%).</p><p><strong>Conclusion: </strong>Earlybird was shown to be a reliable tool for assessing peripheral arteries across raters, with good inter- and intra-rater reliability. The angle-independent variables, RI and AT, showed narrow 95% limits of agreement, which justifies further exploration.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"579251"},"PeriodicalIF":1.5,"publicationDate":"2026-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13005978/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147505324","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":"Evidence of the Utility of Needle-Free Injectable Devices for Subcutaneous Administration of Biopharmaceuticals: Comparable Study of in vivo Pharmacological and Vaccination Ability to Normal Injection.","authors":"Toru Taharabaru, Yuto Kubohira, Kensuke Taniguchi, Taiji Horita, Taishi Higashi, Keiichi Motoyama","doi":"10.2147/MDER.S582443","DOIUrl":"https://doi.org/10.2147/MDER.S582443","url":null,"abstract":"<p><strong>Background: </strong>Needle-free injectable (NFI) technology has attracted increasing attention as a promising alternative to conventional needle-based injections. NFI devices offer several advantages, including reduced pain, minimized medical waste, and the elimination of needlestick injury risks. However, quantitative evidence comparing their pharmacological performance with that of standard subcutaneous (SC) injections remains limited, particularly for different biopharmaceuticals.</p><p><strong>Methods: </strong>We compared a novel NFI device (SAIJECT^®) with conventional needle-based SC injection for the administration of model biopharmaceuticals. The pharmacological activities of insulin were evaluated based on blood glucose levels, including time-dependent hypoglycemic response. The antigen-specific antibody production levels after the injection of Ovalbumin (OVA, a model antigen for vaccination) were also evaluated. Furthermore, the physical mechanism of drug delivery by the NFI device was visualized by studying the penetration of Evans blue dye after injection.</p><p><strong>Results: </strong>There was no significant difference in the pharmacological activities of insulin and OVA delivered via the NFI-device and those via standard SC injection, suggesting that the NFI device was comparable to normal injection. Evans blue dye injected by the NFI device was broadly distributed throughout the dermis and subcutaneous tissue without skin perforation, leakage, or localized accumulation. These results indicate that NFI device can deliver drugs efficiently into the subcutaneous tissue while maintaining tissue integrity. Moreover, this NFI device exhibited negligible drug adsorption, indicating favorable physicochemical compatibility.</p><p><strong>Conclusion: </strong>These findings provide direct evidence supporting the applicability of NFI technology for the SC delivery of biopharmaceuticals and highlight the potential of the NFI devices as a practical and effective alternative to conventional needle-based injection methods. In addition, this comprehensive evaluation of NFI devices provides fundamental insights for the translational application of NFI devices as a practical alternative to needle-based injections.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"582443"},"PeriodicalIF":1.5,"publicationDate":"2026-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12978008/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147445514","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}