Neuroendovascular venous interventions are increasingly performed using technologies originally developed for arterial procedures and indications. However, the major dural venous sinuses possess a unique intraluminal anatomy that is not present in arteries, raising concerns about device-anatomy interactions that may affect procedural performance. We used a perfused human cadaveric model with direct intraluminal angioscopic visualization to evaluate currently available endovascular devices within the dural venous sinuses and to characterize mechanisms of device-anatomy interactions associated with technical difficulty and failure. Six fresh human head-and-neck cadaveric specimens were perfused with 0.9% saline solution via bilateral internal jugular vein catheterization using a peristaltic pump. Direct intraluminal angioscopic visualization was achieved through transcranial access to the major dural venous sinuses, allowing real-time observation of target segments during device manipulation. Standard endovascular maneuvers were performed within the dural venous sinuses, including guidewire and microcatheter navigation, catheter advancement, venous stent deployment, stent retriever deployment, aspiration thrombectomy, and balloon angioplasty. Angioscopic and fluoroscopic recordings were independently reviewed by experienced neurointerventionists to identify and categorize technical challenges and failure mechanisms. Angioscopy revealed multiple device-intraluminal interactions that were not fully appreciated on fluoroscopy alone. Several representative technical challenge and failure scenarios were identified and grouped into four principal mechanisms: (1) catheterization of venous channels parallel to the main sinus lumen, resulting in catheter entrapment and incomplete expansion of venous stents and stent retrievers; (2) device deformation or incomplete expansion due to intraluminal bands, including stent deformation, malposition, and constrained balloon angioplasty; (3) arrested or impaired device advancement caused by intraluminal bands, frequently necessitating microcatheter-assisted support to overcome ledge effects; and (4) interaction with arachnoid granulations leading to occlusion of aspiration catheter inlets and impeded intraluminal navigation. The venous system differs fundamentally from arteries in luminal geometry and internal architecture. Our findings demonstrate that arterial-derived devices incompletely accommodate these differences, resulting in parallel channel navigation, constrained expansion and deformation of stents, and occlusion of suction catheters. These findings highlight the fact that veins are not arteries and underscore the need for venous-specific techniques and technologies.
Diverting loop ileostomy (DLI) after low anterior resection for rectal cancer reduces the clinical consequences of anastomotic leakage but is associated with significant morbidity, impaired quality of life and the need for a second operation for stoma closure. Temporary intraluminal bypass devices have been developed to protect the anastomosis while avoiding DLI. However, high-quality prospective data comparing such devices with standard DLI remain limited. This study aims to evaluate the safety and effectiveness of the Colovac device compared with DLI. SafeHeal Studies (SAFE-3), consisting of SafeHeal Standard of Care (Diverting Ileostomy) study (SH-SOC23) and SafeHeal Colovac Anastomosis Protection Device Evaluation Pivotal Study (SAFE-3CV), is an international, multicentre, prospective, non-randomised comparative study comprising two sequential cohorts: SH-SOC23 (standard-of-care diverting ileostomy control) and SAFE-3CV (Colovac anastomosis protection device). A total of 233 patients will be enrolled (SAFE-3CV n=108-120; SH-SOC23 n=132) across 25 centres in 4 countries. The primary endpoints are the rate of major complications at 9 months for safety and stoma avoidance at day 10 for effectiveness. Secondary outcomes include overall postoperative morbidity, stoma-related complications, reoperation rates, length of stay and stoma avoidance. Sample size calculation is based on non-inferiority assumptions. Data will be analysed using intention-to-treat principles, with propensity score adjustment to account for baseline differences between cohorts. Comparative analyses will include logistic regression and sensitivity analyses. The study was approved by ethics committees at the country level or at individual sites as per individual country requirements. An independent safety monitoring committee regularly reviews adverse events and safety data throughout the study. Results will be disseminated through peer-reviewed publications and presentations at international meetings. SH-SOC23: NCT06152276 and SAFE-3CV: NCT07116668.
Equity, diversity, and inclusion (EDI) considerations are increasingly emphasised in clinical research, yet their integration within pivotal medical device investigations remains unclear. This scoping review mapped how EDI principles are addressed in pivotal device clinical investigations across therapeutic areas. We conducted a scoping review in accordance with Joanna Briggs Institute guidance and PRISMA-ScR reporting standards. MEDLINE, Embase, and Cochrane CENTRAL were searched for peer-reviewed studies published within the past five years. Eligible studies were pivotal clinical investigations of medical devices - defined as studies intended to support regulatory approval or to provide primary evidence of safety and effectiveness - in human participants. Data were extracted using frameworks informed by PRO-EDI, PROGRESS-Plus, INCLUDE Ethnicity, and CONSORT-Equity, and synthesised across key domains including reporting practices, recruitment and eligibility, population representation, and geographical variation. Seventy-four studies were included, predominantly randomised controlled trials (68/74, 91.9%). Age and sex were universally reported, but integration into analytic frameworks was limited; 18.9% conducted age-based subgroup analyses and 14.8% sex-based analyses. Race/ethnicity was reported in 35.1% of studies and rarely incorporated into outcome analyses. Additional PROGRESS-Plus variables were reported in only 9.5% of studies. Explicit EDI framing within trial design, recruitment, or analysis was uncommon (2.7%), and no study applied CONSORT-Equity. Recruitment was largely clinic-based, and none conducted population benchmarking or formal representativeness analyses. Structural and procedural barriers to participation, such as geographic access, cost, time burden and health system constraints, were infrequently acknowledged (12.2%) and were rarely conceptualised as determinants of representation or incorporated into study design, recruitment strategies, or analytic frameworks. Pivotal device investigations routinely report basic demographics but rarely embed structured equity considerations in design or analysis. The absence of population benchmarking and limited subgroup evaluation constrain assessment of external validity. Strengthening equity-oriented reporting and analytic integration in pivotal trials may enhance the inclusiveness and applicability of evidence supporting device approval and clinical use.
Spatial methods are critical to the understanding of infectious disease transmission and accurate exposure assessments. It is widely acknowledged that a One-Health approach is required to understand infectious disease processes, implying that knowledge of spatial patterns of both humans and animals is necessary. This is particularly so in urban areas and informal settlements where human-animal interactions are increasing. Towards this, we have described in prior work the feasibility of geotracker deployments using Tractive Global Positioning System (GPS) devices. This study extends that work by examining the validity (difference between true and reported locations) and reliability (reported locations remaining constant while in the same location) of data obtained from the deployment of tractive GPS devices in urban environments in Nairobi, Kenya. We recorded GPS data in three different types of locations - open spaces, alleyways, and inside homes - in each of two neighborhoods characterized by different socioeconomic statuses (SES). Our results from a set of generalized linear models indicated that the median distance between true and reported locations ranged from 9 m to 28 m, depending on housing density and location type, with the upper bound of 95% prediction intervals ranging from 16 m to 53 m, again depending on housing density and location type. In addition, Tractive devices showed very strong reliability in both our lower- and higher-housing density neighborhoods, with median distances ranging from 0-1 m between sequential reported locations while not moving. This implies that these geotracking devices are useful for understanding where humans and animals spend their time, but only up to a certain level of spatial granularity.
Autoinjectors (AJs) are medical devices enabling precise subcutaneous self-administration of medicines. An important challenge in modelling these devices is accurately predicting injection time, which significantly impacts device usability, drug delivery and patient experience. Existing literature models for injection time are based on the balance of forces acting on the stopper. These typically include a driving force, resistance due to the flow of liquid through the needle, and friction between the stopper and syringe wall. In some cases, incomplete mechanistic understanding can lead to an oversimplified treatment of friction resulting in poor predictions of delivery time. This study presents a hybrid modelling approach that integrates physics-based and data-driven components including Artificial Neural Networks and Gaussian Processes. By integrating mechanistic modelling with surrogate models, the proposed approach overcomes key limitations of existing models and provides an accurate dynamic representation of the friction forces involved in the injection process. The hybrid models developed demonstrate enhanced descriptive capabilities for friction forces acting between the plunger and the syringe inner walls, offering a more comprehensive understanding of the complex physical phenomena involved in the AJ.
In this paper, the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS), discusses the current regulatory landscape associated with change management of orally inhaled and nasal drug products (OINDP) and other drug device combination products in the European Union. The paper also describes current challenges related to alignment of regulatory expectations, particularly for integral drug device combination products, and proposes topics for further discussion with regulatory agencies and stakeholders to help advance alignment. To further illustrate current challenges and industry approaches to meeting change management requirements, we also present results of an IPAC-RS benchmarking survey and case studies, and outcome from interactions with notified bodies and regulatory agencies. This document is intended to be used as a guideline for industry alignment.
This study examines adolescent experiences with intrauterine device (IUD) insertion under conscious sedation. We conducted a prospective pilot study of 11-21-year-olds who chose conscious sedation for their IUD insertion. Participants completed pre-procedure surveys (e.g., demographics, anticipated pain, reproductive history) and post-procedure surveys (e.g., pain during insertion and overall experience). Providers completed a survey on the day of IUD insertion with sedation type, complications, and reason for sedation. In 16 youth (16.1 ± 1.8 years), 14 received moderate sedation (intravenous midazolam and fentanyl) and 2 received light sedation (nitrous oxide). The most reported "worst part" was procedural cramps (n=5, 31%). The "best part" was sedation effects (n=7, 44%). All patients who received light sedation remembered the insertion compared to 2 of 14 (14%) patients who received moderate sedation. Patients reported an average satisfaction score of 83 on a 100-point visual analogue scale, with no difference between sedation types. Adolescents were highly satisfied with procedural sedation for IUD insertion. Fewer participants remembered the procedure when they received moderate compared to light sedation. IUDs are effective as reversible contraception and menstrual management. The pelvic exam and pain may discourage use of the IUD, but sedation offers an alternate experience. Examining patient experiences will help clinicians counsel future patients on their anticipated experience and provides evidence-based rationale for modification and expansion of this service.
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To evaluate the safety and use of a robotic-assisted electrode insertion system for cochlear implantation in pediatric patients aged 4 to 12 years. Fourteen pediatric patients (ages 4-12 years) underwent unilateral cochlear implantation with robotic-assisted electrode array insertion in this prospective, non-randomized, multicenter study. The primary outcome was the incidence of device-related serious adverse events (SAEs) through 30 days after cochlear implant activation. Secondary outcomes included successful electrode insertion using the robotic-assisted system, insertion time and speed, and evaluation of electrode position. All 14 patients underwent successful robotic-assisted electrode insertion with no device-related serious adverse events through 30 days post-activation. Seven adverse events were reported, all non-device related and resolved without sequelae. Surgeons reported successful device setup, use, and detachment in 93% of cases. Anatomic considerations unique to pediatric cases-such as smaller mastoid cavities and thinner cortex at the mounting site-were successfully managed with preoperative planning and intraoperative modifications. Robotic-assisted cochlear implant electrode insertion in children aged 4-12 years was safe across multiple centers, with high procedural success rates and no device-related SAEs. Awareness of unique pediatric anatomic constraints and technical adjustments can support safe device mounting and controlled insertion. Given the lifespan and potential for new or emerging technologies for the pediatric population, the potential of robotic assistance to reduce intracochlear trauma is an important consideration.
The layered antiferromagnet CrSBr features magnons coupled to other quasiparticles, including excitons and polaritons, which enables their easy optical accessibility. In this work, we investigate the response of the magnons in few-layered devices to changes in carrier density and an applied perpendicular electric field. While the frequencies of both modes increase with the electron density, we reveal their asymmetric response with respect to the electric field. To understand the mechanism of this disparity, we propose a layer-resolved macrospin model describing the magnetic dynamics in thin, non-uniformly doped devices. Through this model we establish the dominant dependencies of the interlayer exchange interaction, magnetic anisotropy, and magnetic moment on the electron density and electric field in individual layers. We demonstrate an on-chip tunability of the in- and out-of-phase magnon frequencies by up to 2 GHz in a dual-gated trilayer device. Our results advance the applications of gate-tunable magnonic devices based on 2D materials.
Much of the existing literature for wave energy converters focuses on devices tailored to grid-scale performance. In this paper, we present the development of TigerRAY, a small, blue-economy scale wave energy converter, designed to generate 100 W in fetch limited waves. This development process involved in-lab dynamometer testing, two years of drifting field tests, and a two month moored deployment on Lake Washington. Through this process, we show the impact of proper ballasting to TigerRAY's performance, and highlight the importance of dynamometer testing to PTO development and characterization. We also show that power electronics are critical not only to the power output of the device, but to the device dynamics as well. We demonstrate the feasibility of a wave energy converter hosting a dock for an uncrewed underwater vehicle in the field, successfully docking the vehicle with the wave energy converter in all six demonstration attempts. Finally, we provide analysis of data from field testing. TigerRAY's relationship between power output and significant wave height remains relatively constant through changing wave directions, float locations, and power electronics functionality.
Vibrational spectroscopy, due to its inherent specificity in providing a spectral "fingerprint" of molecular composition, is an important tool to identify and quantify molecules in environmental, clinical, biotechnological, security, and manufacturing process applications, for example. Optical waveguide chips, offering mass production, robustness, sensitivity and the potential for widespread, low-cost deployment as sensors, are being exploited in two principal forms of vibrational spectroscopy, waveguide mid-infrared spectroscopy (WMIRS) and waveguide-enhanced Raman spectroscopy (WERS). For both, key strands of present research include reducing waveguide attenuation, increasing light/matter interaction strength, exploring methods to deal with complex samples such as using machine learning approaches and on-chip integration of photonic devices to enhance functionality and improve performance. The mid-infrared materials and devices for WMIRS are less well developed than the near-infrared materials and devices normally used for WERS, requiring focussed research into these aspects, including new sources and detectors, and into mitigating the water absorption which can dominate parts of the MIR spectrum. In the case of WERS, additional key strands of research include reducing and mitigating the background emission from waveguide materials, enhancing the Raman signal strength, and incorporating combined plasmonic nanometallic structures with WERS. Additionally, for WERS, the issue of sample complexity hindering molecular identification is being addressed by the inclusion of Raman reporters in assays. MWIRS has been successfully applied to gas sensing, detection of compounds in breath for cancer and infection diagnosis and to bacterial discrimination in aqueous samples, for example. WERS has recently been applied to the detection of antibiotics in plasma and, for example, to cardiac biomarkers. There is now a growing trend towards commercialisation of WERS in particular, which should lead to increased application to real samples and advances in the development of practical sensors. In this review, we focus on the trends in research in WMIRS and WERS in the past 2 years.
Quantum spin liquids can arise from Kitaev magnetic interactions, and to exhibit fractionalized excitations with the potential for a topological form of quantum computation. This review surveys recent experimental and theoretical progress on the pursuit of phenomena related to Kitaev magnetism in layered and exfoliatable materials, which offer numerous opportunities to apply powerful techniques from the field of atomically thin materials. We primarily focus on the antiferromagnetic Mott insulator α-RuCl3, which exhibits Kitaev couplings and is readily exfoliated to single-or few-layer sheets, and thus serves as a test bed for developing probes of Kitaev phenomena in atomically thin materials and devices. We introduce the Kitaev model and how it is realized in α-RuCl3 and other material candidates; and cover α-RuCl3 synthesis and fabrication into van der Waals heterostructure devices. A key discovery is a work-function-mediated charge transfer that heavily dopes both the α-RuCl3 and proximate materials, and can enhance Kitaev interactions by up to 50%. We further discuss a wide range of recent results in electronic transport and optical and tunneling spectroscopies of α-RuCl3 devices. The experimental techniques and theoretical insights developed for α-RuCl3 establish a framework for discovering and engineering superior two-dimensional Kitaev materials that may ultimately realize elusive quantum spin liquid phases.
Dual-mode photodetectors with vertically stacked photoactive layers enable bias-controlled, band-selective extraction from their constituent photoactive layers. While their applications ranging from non-invasive diagnostics to optical communication demand high-fidelity detection of faint light, performance is often limited by interlayer-derived structural complexity and noise. Here, we present an interlayer-free monolithic organic/PbS photodetector that achieves visible and short-wave infrared dual-mode operation with low noise and crosstalk. Inducing vertical and lateral phase-separation in the organic layer facilitates charge carrier dynamics that yield high specific detectivity without auxiliary interlayers, enabling simple device structures that detect small signals with high precision. This strategy can be utilized in a variety of photoactive layer combinations spectrally targeted for application-specific devices. Its practicality is demonstrated through single-pixel imaging, which reconstructs high-fidelity images across visible and SWIR bands even under light attenuation. Furthermore, its dual-mode capability enables silicon alignment through registration of front- and back-side features.
Spin-source materials for spintronic devices are required to convert charge currents into spin currents efficiently and maintain minimal electrical losses. However, conventional strategies to enhance charge-spin conversion often come at the cost of increasing ohmic dissipation. Here we demonstrate that introducing polar lattice distortions into a highly conductive metal can overcome this trade-off. We report the discovery of polar displacements in PtCoO2 and show that these displacements enhance charge-spin conversion by two orders of magnitude compared with its non-polar phase. The coexistence of polarity and metallicity yields a room-temperature spin Hall conductivity of 1.6 × 107ℏ/2e (Ω m)-1. Electron ptychography reveals that the inversion-symmetry breaking originates from local polar nano-regions. Polar PtCoO2 drives efficient spin-orbit torque switching with substantially reduced switching voltage and power compared with Pt-based control devices, and is compatible with silicon substrates, establishing a strategy for designing highly efficient spin-source materials.
The principle of complete vessel restoration in percutaneous coronary intervention (PCI) has highlighted the significance of drug-coated balloons (DCBs) as a crucial substitute for enduring metallic stents, associated with potential hazards like neoatherosclerosis and delayed stent thrombosis. Although paclitaxel-coated balloons (PCBs) are widely accepted as the preferred option for managing in-stent restenosis (ISR) due to their lipophilic and cytotoxic characteristics, sirolimus-coated balloons (SCBs) have surfaced as a potentially less risky alternative, exploiting a cytostatic mode of action. This review synthesizes clinical evidence from 10 randomized controlled trials (RCTs) and 7 meta-analyses published between 2020 and 2025. The analysis focuses on comparative safety and efficacy across major indications: in-stent restenosis (ISR), de novo small vessel disease (SVD), and bifurcation lesions. • In-Stent Restenosis (ISR): Multiple trials (e.g., Scheller et al. 2022, BIO ASCEND ISR) demonstrated the non-inferiority of limus-based platforms compared to PCBs. For instance, late lumen loss (LLL) was nearly identical between groups (0.25 mm for PCB vs. 0.26 mm for SCB). However, the REFORM trial failed to show non-inferiority for a biolimus-coated balloon, highlighting that outcomes are often device-specific rather than a class effect. • De Novo Small Vessel Disease: Outcomes in this category were more heterogeneous. In the TRANSFORM I trial, the MagicTouch SCB failed to meet non-inferiority for net lumen gain compared to the SeQuent Please Neo PCB. Conversely, other studies observed comparable LLL between the two platforms. • Safety Profile: Across most indications, Major Adverse Cardiac Events (MACE) and Target Lesion Failure (TLF) rates were comparable between paclitaxel and sirolimus platforms at 12-month follow-up. PCBs demonstrated a higher frequency of "late lumen enlargement" compared to SCBs. Both paclitaxel and sirolimus-based DCBs are effective for treating in-stent restenosis. However, in de novo lesions, PCBs currently maintain a more consistent evidence base. Clinical performance appears heavily dependent on device-specific factors such as coating technology and excipient formulation rather than a general class effect. Extended follow-up data (3-5 years) are still required to fully evaluate long-term safety and the risk of very late thrombosis.
To evaluate the clinical effectiveness, safety, and impact on quality of life of vertebral distraction techniques in patients with early-onset scoliosis (EOS) through a systematic review and meta-analysis. The techniques evaluated were conventional growing rods (CGR), magnetically controlled growing rods (MCGR), and the VEPTR device. A systematic review was conducted following PRISMA guidelines. Comparative studies, systematic reviews, and economic evaluations published between 2012 and 2023 were included. The analyzed outcomes were Cobb angle, T1-S1 length, quality of life, and complications. Certainty of the evidence was assessed using the GRADE approach. Meta-analyses were performed using fixed- or random-effects models according to heterogeneity. A total of 29 primary comparative studies were included in the meta-analyses of effectiveness and safety. MCGR showed greater Cobb angle correction compared with VEPTR (MD = -22.07°; 95% CI: -31.52 to -12.62) and a lower proportion of patients with at least one complication compared with CGR (RR = 0.54; 95% CI: 0.38 to 0.78). No clinically relevant differences in radiographic correction were observed between CGR and MCGR. CGR were associated with a significant improvement in the psychosocial dimension of quality of life. The certainty of evidence was rated as low or very low for most outcomes. No clinically relevant differences were observed in the correction of large deformities between CGR and MCGR, although MCGR tend to be associated with a lower proportion of patients with complications. The VEPTR device maintains a specific role in patients with thoracic insufficiency syndrome. The available evidence is limited and of low or very low certainty; therefore, higher-quality studies are required to establish robust clinical recommendations.
A key metric utilized by coaches and athletes to track athlete performance is heart rate variability (HRV). HRV calculated via electrocardiogram (ECG) has been shown to track autonomic function. However, many wearable devices utilize photoplethysmography (PPG) to calculate pulse rate variability (PRV). Our study investigated the agreement between PRV and HRV in a beat-to-beat analysis in a sample of American football players. Data from 103 male, Division I collegiate American football athletes, collected over three seasons, were analyzed. Heart rate (HR), pulse rate (PR), and two time-domain indices for PRV/HRV were measured (rMSSD and SDNN). Agreement between PRV and HRV was assessed using Bland-Altman analysis (bias, limits of agreement, and confidence intervals) with supporting error metrics (MAE, RMSE, Pearson r, and Lin's concordance correlation coefficient). To evaluate whether PRV detected autonomic deviations of the same magnitude to HRV on the same day, a sliding-window z-score threshold-crossing analysis (0.5-2.0 SD) quantified PRV detection rates and PRV delay. HR and PR were similar at (59.4 (10.3) bpm vs. 59.7 (10.3) bpm). In contrast, PPG-PRV values were lower than ECG-HRV for both rMSSD and SDNN (80.9 (23.1) ms vs. 103.9 (22.0) ms, 141.3 (41.7) ms vs. 167.9 (40.0) ms). Bland-Altman analysis showed negative bias for rMSSD and SDNN across PPG wavelengths, race, and obesity, while HR/PR agreement was high with small bias (0.24-0.44 bpm). In the deviation analysis, PRV detected fewer autonomic deterioration events on the same day as HRV, capturing 16.7% to 56.7% of HRV-identified rMSSD events and 16.8%-52.0% of SDNN events across thresholds, and exhibited an average delay of 1.8-5.5 days in detecting changes already identified by ECG-HRV. Our findings refute PPG-PRV as an equivalent surrogate for ECG-HRV for tracking autonomic function over time. Specifically, the delay in response when using PPG-PRV to track athlete autonomic function will result in missed opportunities for coaches to prevent autonomic deterioration. Finally, the PRV calculated with PPG should not be called HRV as it confuses scientists and consumers.
This study provides a large-scale clinical validation of a non-invasive method to characterize the mechanical properties of tumoral and non-tumoral human skin, aiding dermatological diagnosis and establishing a database for future research. The non-contact UNDERSKIN device employs Fourier transform calculations to analyze surface wave dispersion generated by a focused airflow, via a skin-specific inversion model combined with a viscoelastic model. This digital palpation technology provides detailed insight into subsurface particle motion, revealing new mechanical responses of basal cell carcinomas (BCC). Conducted ex vivo on over 160 BCC and 40 healthy skin specimens, the results quantify the viscoelastic behavior of each skin layer. Although dermatologists can assess tissue firmness through palpation, they currently cannot objectively quantify it or determine its origins. This technique provides that missing quantification, linking tactile perception to specific biomechanical properties. By measuring where firmness originates within skin layers, this work offers valuable support for improving diagnosis, prognosis, treatment planning, surgical decisions, and the advancement of teledermatology applications.