Nathan C Hurley, Bobak J Mortazavi, Sanket S Dhruva, Joseph S Ross, Che G Ngufor, Jeptha P Curtis, Harlan M Krumholz, Nihar R Desai
{"title":"Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support.","authors":"Nathan C Hurley, Bobak J Mortazavi, Sanket S Dhruva, Joseph S Ross, Che G Ngufor, Jeptha P Curtis, Harlan M Krumholz, Nihar R Desai","doi":"10.2147/MDER.S585943","DOIUrl":"10.2147/MDER.S585943","url":null,"abstract":"<p><strong>Introduction: </strong>Acute myocardial infarction complicated by cardiogenic shock (AMI-CS) is a heterogeneous clinical syndrome associated with substantial morbidity and mortality. We developed a machine learning-based mortality model to identify features and patient subgroups associated with the largest change in mortality risk when evaluating treatment with Impella devices or intra-aortic Balloon Pump (IABP).</p><p><strong>Methods: </strong>Our cohort comprised 369 sites and 15,796 patient visits to the cardiac catheterization laboratory from the National Cardiovascular Data Registry. We developed XGBoost decision tree models to model mortality with and without treatment variable included (Impella or IABP).</p><p><strong>Results: </strong>The estimated population mean excess mortality effect of treatment with Impella devices vs IABP was 10.4 ± 0.8%. However, we identified clinical subgroups of 282 patients for whom a decreased risk of mortality was associated with use of Impella as compared with IABP. Those patients were on average younger, presented with higher systolic blood pressure, higher rate of salvage percutaneous coronary intervention, higher initial creatinine, and lower hemoglobin.</p><p><strong>Discussion: </strong>While Impella devices were associated with higher mortality risk overall, certain clinical profiles were associated with lower risk, illustrating heterogeneity of treatment effects.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"585943"},"PeriodicalIF":1.5,"publicationDate":"2026-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12967445/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147391416","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}
Dodit Suprianto, Loeki Enggar Fitri, Akhmad Sabarudin, Wayan Firdaus Mahmudy, Muhammad Hatta Prabowo, Werasak Surareungchai
{"title":"A Systematic Review and Meta-Analysis of Diagnostic Test Accuracy for Human Toxoplasmosis: Performance, Populations, and Validation Gaps.","authors":"Dodit Suprianto, Loeki Enggar Fitri, Akhmad Sabarudin, Wayan Firdaus Mahmudy, Muhammad Hatta Prabowo, Werasak Surareungchai","doi":"10.2147/MDER.S569457","DOIUrl":"10.2147/MDER.S569457","url":null,"abstract":"<p><strong>Background: </strong>Accurate and timely diagnosis of toxoplasmosis is crucial for clinical management, particularly in high-risk populations. Despite a diverse diagnostic landscape spanning laboratory-based serology, molecular assays, point-of-care (POC) devices, and emerging technologies, a consolidated quantitative synthesis of their performance and clinical readiness is lacking.</p><p><strong>Methods: </strong>This systematic review and diagnostic test accuracy meta-analysis employed a dual-method design, integrating evidence mapping and quantitative synthesis. We searched Embase, PubMed, Scopus, IEEE Xplore, and other databases from January 1, 2010, to December 31, 2025, for studies evaluating diagnostic tests for human toxoplasmosis. Evidence mapping classified technologies by target, specimen, and validation stage (Tiers 0-3). Meta-analysis pooled sensitivity and specificity using bivariate random-effects models for subgroups with sufficient data. Risk of bias was assessed using QUADAS-2.</p><p><strong>Results: </strong>Evidence mapping identified 175 studies yielding 309 diagnostic test evaluations across 37 target groups, 20 clinical populations, and 11 technological categories. Most studies evaluated conventional laboratory assays (75.9%), followed by point-of-care tests (20.9%) and emerging technologies (3.2%). Meta-analysis included 182 test evaluations (42,287 samples) and showed that accuracy differed by detection target, population, and platform. Among targets, IgG+IgM and IgG avidity demonstrated the strongest combined performance (IgG+IgM sensitivity 94.8% [95% CI 89.4-97.5], specificity 96.7% [93.9-98.3]; IgG avidity sensitivity 90.8% [84.9-94.5], specificity 97.1% [91.7-99.0]), whereas DNA assays showed a rule-in profile with lower sensitivity (66.0% [51.9-77.7]) but high specificity (96.2% [94.3-97.5]). Performance varied across clinical populations, with a notable diagnostic gap in other immunocompromised patients (sensitivity 55.7% [33.1-76.2] despite specificity 97.7% [92.3-99.3]). By platform, POCTs had high specificity (97.4% [95.4-98.5]) and good sensitivity (87.7% [80.3-92.6]) compared with conventional assays (84.7% [80.2-88.3]; 95.5% [94.2-96.6]).</p><p><strong>Conclusion: </strong>Diagnostic accuracy for toxoplasmosis is highly context-dependent. Serology remains central, with IgG avidity (and high-performing IgG+IgM strategies) supporting infection dating, and POCTs offering rapid, high-specificity rule-in utility when embedded in appropriate clinical algorithms. The persistently reduced sensitivity in immunocompromised populations highlights an urgent unmet need for improved diagnostics and more rigorous, standardized real-world validation.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"569457"},"PeriodicalIF":1.5,"publicationDate":"2026-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12967108/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147379125","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}
Laura Serrano Díaz, Barbara Defilippo, Marita Windpassinger, Sabine Maes, María Elena Gesto Lagüela, Trevor J Steele, Jenny Serrano, Kyle De Boer
{"title":"The Safety and Efficacy of Disinfection Cap Use in a Real-World Environment.","authors":"Laura Serrano Díaz, Barbara Defilippo, Marita Windpassinger, Sabine Maes, María Elena Gesto Lagüela, Trevor J Steele, Jenny Serrano, Kyle De Boer","doi":"10.2147/MDER.S568196","DOIUrl":"https://doi.org/10.2147/MDER.S568196","url":null,"abstract":"<p><strong>Purpose: </strong>Catheter hub and needle-free connector contamination is a causative element in the development of catheter-related bloodstream infections and demonstrates the necessity for effective hub disinfection. The current study evaluated the safety and efficacy of a disinfection cap used in a real-world environment.</p><p><strong>Patients and methods: </strong>This multicenter, single-arm, prospective post-market study was designed to collect clinical data on the safety and performance of a passive disinfection cap. A total of 157 participants were included in this study. The primary performance endpoints were attachment and removal success rates. The primary safety endpoint was the rate of device-related AEs.</p><p><strong>Results: </strong>A total of 156 participants, aged 3-93 years, had at least one disinfection cap applied during the study. Attachment and removal success was ≥ 99.7%. No device-related adverse events were observed.</p><p><strong>Conclusion: </strong>This study found that disinfection caps can be attached and removed successfully with no device-related adverse events in a real-world environment.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"568196"},"PeriodicalIF":1.5,"publicationDate":"2026-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12951736/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147349515","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}
Bo E V Håkansson, Karl-Johan Fredén Jansson, Luca Verrecchia, Zheer Tawfique, Laura Froehlich, Julia Dlugaiczyk, Torsten Rahne, Måns Eeg-Olofsson, Emil Håkansson, Sabine Reinfeldt
{"title":"Ocular VEMP Using Bone Conduction Stimuli at the Forehead - A Pilot Study Comparing B250, Minishaker and Tendon Hammer with Vibrometry Validation.","authors":"Bo E V Håkansson, Karl-Johan Fredén Jansson, Luca Verrecchia, Zheer Tawfique, Laura Froehlich, Julia Dlugaiczyk, Torsten Rahne, Måns Eeg-Olofsson, Emil Håkansson, Sabine Reinfeldt","doi":"10.2147/MDER.S560014","DOIUrl":"https://doi.org/10.2147/MDER.S560014","url":null,"abstract":"<p><strong>Background: </strong>Bone-conduction stimuli in oVEMP testing offer lower stimulus levels and independence of conductive hearing loss but lack a clinically suitable transducer for excitation. A new bone-conduction transducer (B250) has been developed which is easy to attach and can be directly connected to test stations.</p><p><strong>Objective: </strong>To compare, in a pilot investigation B250, Minishaker and Tendon hammer excitation, used for oVEMP and mastoid vibration measurements.</p><p><strong>Methods: </strong>oVEMPs in three subjects were measured using transducers driven by a 250 Hz condensation single sinus cycle and with a Tendon hammer, all applied at forehead Fz/AFz. Corresponding mastoid velocity was measured using a laser Doppler vibrometer (LDV).</p><p><strong>Results: </strong>B250 and Minishaker often produced dual oVEMP peaks with an early n1 (mean latency: 8.8 ms) and a late n2 response (B250: 12.4/Minishaker: 13.3 ms), and with the Tendon hammer response in between. This finding was supported by a reinvestigation of a previous study (n=15). LDV velocity shows several positive peaks for B250 and one positive peak for the Minishaker. The acceleration response has two peaks 4 ms apart for both transducers, which seem to relate to the early and late oVEMP latencies.</p><p><strong>Conclusion: </strong>B250 may serve as a potential alternative, pending validation in larger samples, to the Minishaker at the forehead, but with care to polarity choice and latency interpretation.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"560014"},"PeriodicalIF":1.5,"publicationDate":"2026-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12912185/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146221541","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}
Taj El-Khalili, Lara Varma, Karley Yanlam Yung, Jinlei Li, Daniel Wiznia
{"title":"The Design and Development of a Novel Device that Converts a Patient-Controlled Intravenous Pump into an Oral Liquid Medication Dispenser for Non-Controlled Substances.","authors":"Taj El-Khalili, Lara Varma, Karley Yanlam Yung, Jinlei Li, Daniel Wiznia","doi":"10.2147/MDER.S582446","DOIUrl":"https://doi.org/10.2147/MDER.S582446","url":null,"abstract":"<p><strong>Background: </strong>Timely administration of oral medications is a significant inpatient challenge, particularly in the context of postoperative pain management with limited nursing resources. Delays in delivering non-opioid analgesics, such as acetaminophen, can result in poorly controlled pain and increased opioid use.</p><p><strong>Methods: </strong>To address this gap, we developed the Patient-Controlled Oral Liquid Dispenser (P-COLD), a novel bedside device that enables patients to self-administer non-controlled liquid medications within programmable safety parameters. The system integrates a hospital-grade intravenous patient-controlled analgesia (PCA) pump into a secure, 3D-printed housing that delivers precise doses of medication into a bedside cup upon patient request.</p><p><strong>Results: </strong>The P-COLD was validated through laboratory testing and simulated-use evaluations without deployment in clinical patient care. Dose accuracy testing demonstrated consistent delivery within ±5% of target volume. Simulated usability testing with healthy volunteers confirmed reliable patient operation with minimal instruction. Nursing staff successfully completed training and setup protocols, and time-motion analyses indicated potential reductions in workflow interruptions and nursing burden during as-needed (PRN) medication delivery.</p><p><strong>Conclusion: </strong>The P-COLD was designed to enable patient-initiated delivery of non-controlled oral liquid medications without IV access and without requiring nurse presence at the bedside for each dose. Validation testing in the laboratory and through simulated use demonstrated accurate dosing, reliable usability, and favorable simulated workflow performance.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"582446"},"PeriodicalIF":1.5,"publicationDate":"2026-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12912084/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146221556","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}
Lauren A Costella, Kate Johnson, Rick Hassan, Mario Villani, Rosanna Villani, Christopher K Tison
{"title":"Evaluation of a Sprayable Hydrogel for Surgical Adhesion Prevention in Rat and Rabbit Models.","authors":"Lauren A Costella, Kate Johnson, Rick Hassan, Mario Villani, Rosanna Villani, Christopher K Tison","doi":"10.2147/MDER.S574967","DOIUrl":"10.2147/MDER.S574967","url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate the effectiveness of a sprayable adhesion barrier in the prevention of postoperative adhesions.</p><p><strong>Methods: </strong>Established rat and rabbit models of abdominal adhesion formation were used to evaluate AeroVeil efficacy. First, 24 Sprague-Dawley rats were randomly assigned to untreated control, Seprafilm-treated, or AeroVeil-treated test groups. Defects were created on abdominal wall and cecum surfaces, with sutures around the injury perimeter to increase the likelihood of adhesion formation. Treated animals were sprayed with recommended AeroVeil dosing over both injured surfaces; a Seprafilm sheet was placed between the two injured surfaces; control animals received no treatment. Additionally, AeroVeil application was compared to untreated controls in 24 New Zealand White rabbits. The abdominal wall and cecum surfaces were abraded to induce adhesion formation. AeroVeil animals were treated with the recommended product dose over both injured tissue sites; control animals were closed without treatment.</p><p><strong>Results: </strong>The incidence, extent, and severity of postoperative adhesion formation were measured by blinded veterinary surgeons at 7 or 28 days. In the rat model, control animals formed adhesions between the cecum and abdominal wall injury sites in 7 of 8 animals. Incidence of this primary adhesion significantly reduced (p < 0.05) to 1 of 8 in Seprafilm-treated animals and 0 of 7 in AeroVeil treated animals, with similarly significant reduction in the extent and severity scores. In the rabbit model, application of AeroVeil decreased the incidence of adhesion formation, with a statistically significant decrease in total adhesion score across all tissue groups.</p><p><strong>Conclusion: </strong>AeroVeil application reduced the incidence and severity of postoperative adhesion formation in two different animal models, with results in the rat model directly compared to an established clinical control (Seprafilm). These findings justify further investigation of AeroVeil in expanded animal models to facilitate clinical translation.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"574967"},"PeriodicalIF":1.5,"publicationDate":"2026-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12911950/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146221551","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}
Franz Wegner, Paul Rasmus Bielenberg, Thomas Friedrich, Eric Aderhold, Pascal Stagge, Jonas Schumacher, Justin Ackers, Mandy Ahlborg, Annika C Dell, Ankit Malhotra, Matthias Graeser, Maria-Josephina Buhné, Malte Maria Sieren, Martin A Koch, Julian Haegele, Roman Kloeckner, Thorsten M Buzug, Jörg Barkhausen, Kerstin Lüdtke-Buzug
{"title":"Simple-to-Fabricate and Water-Stable Instrument Markers for Preclinical Magnetic Particle Imaging and Magnetic Resonance Imaging.","authors":"Franz Wegner, Paul Rasmus Bielenberg, Thomas Friedrich, Eric Aderhold, Pascal Stagge, Jonas Schumacher, Justin Ackers, Mandy Ahlborg, Annika C Dell, Ankit Malhotra, Matthias Graeser, Maria-Josephina Buhné, Malte Maria Sieren, Martin A Koch, Julian Haegele, Roman Kloeckner, Thorsten M Buzug, Jörg Barkhausen, Kerstin Lüdtke-Buzug","doi":"10.2147/MDER.S574399","DOIUrl":"https://doi.org/10.2147/MDER.S574399","url":null,"abstract":"<p><strong>Purpose: </strong>Magnetic Particle Imaging (MPI) is a tracer-based imaging modality with high spatial and temporal resolution, very promising for cardiovascular imaging and peri-interventional guidance. However, most interventional instruments are invisible in MPI due to a lack of signal generation. Existing instrument marking approaches do not address water durability, which is essential for maintaining temporal consistency during experiments. This study aims to develop a simple and water-stable marking technique with smooth surfaces for interventional devices for preclinical MPI and MRI research.</p><p><strong>Material and methods: </strong>Commercial superparamagnetic iron-oxide nanoparticles (SPIONs) were mixed with a transparent varnish and applied to nitinol stents via dip-coating. An impregnation solution was used to seal the markers. The coating was optically evaluated by microscopy. The water-stability of the markers was assessed after 24 hours in water by Magnetic Particle Spectroscopy (MPS) of the surrounding fluid. The imaging performance of the markers was tested in preclinical MPI and MRI systems.</p><p><strong>Results: </strong>Microscopy showed homogeneous SPION distribution and smooth marker surfaces after the sealing. MPS revealed no detectable signal of the water which surrounded the sealed markers, indicating their water-stability. The MPI-scans demonstrated sufficient visualization of individual markers at the stent ends (SNR=11.5). In MRI, susceptibility artefacts of the marked stents were 4.6 times larger compared to unmarked references.</p><p><strong>Conclusion: </strong>The presented technique allows for easy fabrication of instrument markers with commercially available components for preclinical experiments with the magnetic imaging modalities MPI and MRI.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"574399"},"PeriodicalIF":1.5,"publicationDate":"2026-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12911944/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146221518","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}
Laurence Jeppe Russell, Liudi Jiang, Davide Filingeri, Peter R Worsley
{"title":"A Benchtop Evaluation of Cervical Collar Design and Strap Tension.","authors":"Laurence Jeppe Russell, Liudi Jiang, Davide Filingeri, Peter R Worsley","doi":"10.2147/MDER.S541594","DOIUrl":"10.2147/MDER.S541594","url":null,"abstract":"<p><p>This article presents a novel experimental setup for objectively evaluating cervical collar design and fit by monitoring strap tension and interface pressures across the device-skin interface. This study evaluated four commercially available cervical collars, achieving repeatable findings (ICC > 0.93) that were sensitive to differences between collars and across strap tensions. For each collar, there was a significant relationship (r > 0.4, p < 0.005) between strap tension and interface pressure values, with pressures exceeding 100 mmHg for high strap tensions. Differences in the distribution of pressures and the relationship between strap tension and interface pressures highlight the need for these objective measures of design and fit for cervical collars to evaluate new and existing designs.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"541594"},"PeriodicalIF":1.5,"publicationDate":"2026-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13021561/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147575728","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 Comparison of the Bouquet Speculum and Traditional Two-Blade Speculum in Medical Student Training for Female Gynecological Exams.","authors":"Cassandra Brown, Shivani Dixit, Jennifer Gaide","doi":"10.2147/MDER.S556660","DOIUrl":"10.2147/MDER.S556660","url":null,"abstract":"<p><strong>Introduction: </strong>The objective of this study was to compare the Bouquet Speculum™ to a traditional two-blade speculum on a complex-anatomy vaginal task among preclinical medical students. The novel task trainer was designed and created to simulate obese anatomy for the complicated speculum exam. This study was conducted at Rocky Vista University College of Osteopathic Medicine in Parker, Colorado.</p><p><strong>Methods: </strong>A novel vaginal model simulating anatomy that is prone to lateral wall collapse was used to compare the speed and preference of a traditional two-blade vaginal speculum to the Bouquet speculum™ among first and second-year medical students (n=47) in a randomized crossover study. Students performed an endometrial biopsy, and quantitative and qualitative measures were recorded including time, speculum preference, difficulty, and confidence.</p><p><strong>Results: </strong>Students successfully placed the endometrial biopsy pipelle faster using the Bouquet speculum™ compared to the traditional two-blade speculum (p < 0.0001). Students self-reported confidence level was significantly associated with faster times, regardless of the speculum used (p=0.0043).</p><p><strong>Conclusion: </strong>The Bouquet Speculum™ significantly reduces the time to completion of an endometrial biopsy performed on a novel vaginal model simulating obese anatomy compared to the traditional two-blade speculum.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"556660"},"PeriodicalIF":1.5,"publicationDate":"2026-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12794563/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145967454","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}
Milena Natalia Chołuj, Bartosz Tomasz Śmigielski, Gerard Cybulski
{"title":"Mobile Application for Visualization and Analysis of Impedance Cardiography Signals.","authors":"Milena Natalia Chołuj, Bartosz Tomasz Śmigielski, Gerard Cybulski","doi":"10.2147/MDER.S538764","DOIUrl":"10.2147/MDER.S538764","url":null,"abstract":"<p><strong>Background: </strong>Bioimpedance measurement is a noninvasive diagnostic method that enables the assessment of the condition of internal organs and their activity by recording changes in impedance of the examined body area. One of the bioimpedance techniques that allows the evaluation of cardiac mechanical activity, including the estimation of stroke volume, is impedance cardiography (ICG).</p><p><strong>Purpose: </strong>The aim of this project was to create a computer program written in widespread Java, a versatile language, valued for its reliability, scalability, and built-in features that optimize application performance. The application dedicated to mobile devices, written using the Android Studio environment, enables visualization of ICG signals simultaneously with one channel of electrocardiographic signal (ECG) and allows the preliminary analysis of basic hemodynamic parameters.</p><p><strong>Methods: </strong>The signal analysis included determination of heart rate (HR), stroke volume (SV), cardiac output (CO), and left ventricular ejection time (LVET).</p><p><strong>Discussion and conclusions: </strong>The program allows the user the quick visual check of the recorded signal quality, browse the traces and manually select the characteristic points on the ECG and ICG waveforms, which are then used to calculate the ICG-derived cardiac parameters. It may be used to visualize ECG and ICG signals by anyone, who could enter ICG data formatted in three text columns where each row reflects a sample of ECG, first derivative of ICG signal (dz/dt) and basic impedance (Z0).</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"18 ","pages":"615-625"},"PeriodicalIF":1.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12679932/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145702466","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}