Search Results (2,172)

The coagulation cascade triggered by the contact between blood and the surface of implantable/interventional devices can lead to thrombosis, severely compromising the long-term safety and efficacy of medical devices. As an alternative to systemic anticoagulants, surface anticoagulant modification technology can achieve safer hemocompatibility on the device surface, holding significant potential for clinical application. This article systematically elaborates on the latest research progress in the surface anticoagulant modification of blood-contacting materials. It analyzes and discusses the main strategies and their evolution, spanning from physically inert carbon-based coatings and heparin-based drug-functionalized surfaces to hydrophilic/hydrophobic dynamic physical barriers, biologically signaling regulatory coatings, and bio-integrative/regenerative endothelium-mimicking surfaces. The advantages and limitations of the respective methods are outlined, and the potential for synergistic application of multiple strategies is explored. A special emphasis is placed on current research hotspots regarding novel anticoagulant surface technologies, such as hydrogel coatings, liquid-infused surfaces, and 3D-printed endothelialization, aiming to provide insights and references for developing long-term, safe, and hemocompatible cardiovascular implantable devices. Full article

Glaucoma is recognized as the second leading cause of blindness globally and a primary cause of irreversible blindness, estimated to affect over 80 million patients worldwide, including 4.5 million in the United States. Though the disease is multifactorial, the primary cause is elevated intraocular pressure (IOP), which damages the optic nerve fibers that connect the eye to the brain, thus interfering with the quality of vision. Current treatments have evolved, which consist of medications, laser therapies, and surgical interventions such as filtering procedures, glaucoma drainage devices (GDDs), and current innovations of minimally invasive glaucoma surgeries (MIGS). This paper aims to discuss the history and evolution of the design and biomaterials employed in GDDs and MIGS. Through a comprehensive review of the literature, we trace the development of these devices from early concepts to modern implants, highlighting advancements in materials science and surgical integration. This historical analysis, ranging from the mid-19th century, reveals a trend towards enhanced biocompatibility, improved efficiency in IOP reduction, and reduced complications. We conclude that the ongoing evolution of GDDs and MIGS underscores a persistent commitment to advancing patient care in glaucoma, paving the way for future device innovations and therapeutic trends to treat glaucoma. Full article

Background: Animal studies remain fundamental to cardiovascular drug and device development, yet their ability to predict human responses is increasingly being questioned. The US Food and Drug Administration (FDA)’s April 2025 roadmap supports alternative testing approaches that strategically reduce animal use while increasing human relevance by combining laboratory methods, computer simulations, and artificial intelligence. This review examines AI-enabled alternative methodologies for cardiovascular safety assessment within established validation frameworks and regulatory acceptance programs. We describe machine learning approaches for predicting cardiac safety risks, automated analysis of human heart cells, and patient-specific computer simulations for evaluating medical devices. These tools can improve our understanding of biological mechanisms, focus limited animal studies on critical questions, and accelerate decision-making. Regulatory acceptance requires rigorous validation appropriate to each specific use and decision context. Conclusion: We outline practical steps for establishing credibility, including transparent data documentation, independent testing, and identifying where models can be reliably applied, and identify remaining challenges in data standardization and regulatory readiness. With ongoing alignment between regulators, standards bodies, and product developers, these alternative approaches could significantly reduce reliance on animal testing in cardiovascular research while maintaining or improving the quality of evidence. Full article

Additive manufacturing has increasingly become a transformative approach in the design and fabrication of personalized medical devices, offering improved adaptability, reduced production time, and enhanced patient-specific functionality. Within this framework, simulation-driven design plays a critical role in ensuring the structural reliability and performance of orthopedic supports before fabrication. This research study delineates the novel development of a wrist hybrid splint (WHS) which has a simulation-based design and was additively manufactured using fused deposition modeling (FDM). The primary material selected for this purpose was polylactic acid (PLA), recognized for its biocompatibility and structural integrity in medical applications. Prior to the commencement of the actual FDM process, an extensive pre-analysis was imperative, involving the application of nonlinear numerical models aiming at replicating the mechanical response of the WHS in respect to different deposition configurations. The methodology encompassed the evaluation of a sophisticated material model incorporating a damage mechanism which was grounded in experimental data derived from meticulous tensile and three-point bending testing of samples with varying FDM process parameters, namely nozzle diameter, layer thickness, and deposition orientation. The integration of custom subroutines with utility routines was coded with a particular emphasis on maximum stress thresholds to ensure the fidelity and reliability of the simulation outputs on small scale samples in terms of their elasticity and strength. After the formulation and validation of these computational models, a comprehensive simulation of a full-scale, finite element (FE) model of two WHS design variations was conducted, the results of which were aligned with the stringent requirements set forth by the product specifications, ensuring comfortable and safe usage. Based on the results of this study, the final force comparison between the numerical simulation and experimental measurements demonstrated a discrepancy of less than 2%. This high level of agreement highlights the accuracy of the employed methodologies and validates the effectiveness of the WHS simulation and fabrication approach. The research also concludes with a strong affirmation of the material model with a damage mechanism, substantiating its applicability and effectiveness in future manufacturing of the WHS, as well as other orthopedic support devices through an appropriate selection of FDM parameters. Full article

Cardiogenic shock (CS) is a heterogeneous pathophysiological state with high mortality, despite the development of cardiac intensive care units (CICUs) and the advanced treatments applied. The cornerstones of therapy that have been proposed in many algorithms are intravenous (i.v.) pressors and devices for mechanical circulatory support (MCS), depending on the CS profile (left, right, or biventricular involvement), etiology (acute myocardial infarction, heart failure, or other) and SCAI stage (A to E, with MCS generally recommended for Stages C–E). There are many gaps in the evidence regarding i.v. medications and devices, with the existing data being controversial. Moreover, there are differences in the devices’ availability and, as a result, a lack of experience in many centers. In this review article, an algorithm for the management of CS is proposed, and the gaps in every step are presented. Early clinical suspicion that leads to prompt diagnosis, health system organization, large-scale trials, and the configuration of national or regional shock centers could bridge the current therapeutic gaps and balance disparities in the management of CS in order to improve outcomes. Full article

The management of age-related macular degeneration (AMD) presents a significant challenge attributable to high disease heterogeneity. Patient realization of symptoms is poor and it is urgent to treat before permanent anatomic damage results in vision loss. This is true for the initial conversion from non-exudative intermediate AMD (iAMD) to exudative AMD (nAMD), and for the recurrence of nAMD undergoing treatment. Starting from the essential requirements that any practical solution needs to fulfill, we will reflect on how persistent navigation towards innovative solutions during a 25-year journey yielded significant advances towards improvements in personalized care. An early insight was that the acute nature of AMD progression requires frequent monitoring and therefore diagnostic testing should be performed at the patient’s home. Four key requirements were identified: (1) A tele-connected home device with acceptable diagnostic performance and a supportive patient user interface, both hardware and software. (2) Automated analytics capabilities that can process large volumes of data. (3) Efficient remote patient engagement and support through a digital healthcare provider. (4) A low-cost medical system that enables digital healthcare delivery through appropriate compensation for both the monitoring provider and the prescribing physician services. We reviewed the published literature accompanying first the development of Preferential Hyperacuity Perimetry (PHP) for monitoring iAMD, followed by Spectral Domain Optical Coherence Tomography (SD-OCT) for monitoring nAMD. Emphasis was given to the review of the validation of the core technologies, the regulatory process, and real-world studies, and how they led to the release of commercial services that are covered by Medicare in the USA. We concluded that while during the first quarter of the 21st century, the two main pillars of management of AMD were anti-VEGF intravitreal injections and in-office OCT, the addition of home-monitoring-based digital health services can become the third pillar. Full article

Capacitive ECG (cECG) technology offers significant potential for improving comfort and unobtrusiveness in long-term cardiovascular monitoring. Nevertheless, current research predominantly emphasizes basic heart rate monitoring by detecting only the R-wave, thereby restricting its clinical applicability. In this study, we proposed an advanced cECG mattress system and conducted a systematic evaluation. To enhance user comfort and achieve more accurate cECG morphological features, we developed a multi-layered cECG mattress incorporating flexible fabric active electrodes, signal acquisition circuits, and specialized signal processing algorithms. We conducted experimental validation to evaluate the performance of the proposed system. The system exhibited robust performance across various sleeping positions (supine, right lateral, left lateral and prone), achieving a high average true positive rate (TPR) of 0.99, ensuring reliable waveform detection. The mean absolute error (MAE) remains low at 1.12 ms for the R wave, 7.89 ms for the P wave, and 7.88 ms for the T wave, indicating accurate morphological feature extraction. Additionally, the system maintains a low MAE of 0.89 ms for the RR interval, 7.77 ms for the PR interval, and 7.85 ms for the RT interval, further underscoring its reliability in interval measurements. Compared with medical-grade devices, the signal quality obtained by the cECG mattress system is sufficient to accurately identify the crucial waveform morphology and interval durations. Moreover, the user experience evaluation and durability test demonstrated that the mattress system performed reliably and comfortably. This study provides essential information and establishes a foundation for the clinical application of cECG technology in future sleep monitoring research. Full article

Isosorbide-based aliphatic polyesters are a promising class of biodegradable polymers for biomedical applications, representing an attractive alternative to poly(α-hydroxy acids). Derived from the bio-based bicyclic diol, they combine structural rigidity, tunable hydrophilicity, and enhanced biocompatibility, making them suitable for drug delivery and sustainable medical devices. In this study, we developed novel in situ forming implant (ISFI) formulations composed of poly(isosorbide sebacate) (PISEB) and dimethyl isosorbide (DMI), and evaluated their applicability for local delivery of doxycycline hyclate (DOXY), minocycline hydrochloride (MIN), and/or eugenol (EUG). Basic characteristics of new ISFI formulations were investigated. Rheological analysis demonstrated that the liquid formulations exhibited shear-thinning behavior, which is advantageous for ISFI systems. However, the MIN-loaded formulation exhibited excessively rapid drug release, with a pronounced initial burst (86.4 ± 5.9%) within 24 h, whereas the DOXY-loaded system showed a lower burst of 41.1 ± 5.9% over the same period. The effect of EUG addition on depot morphology and antibiotic release profiles was also assessed. In vitro drug release studies demonstrated that EUG reduced the release rate of both antibiotics, increasing and prolonging their antibacterial activity. Eugenol co-released with antibiotics also reduced the pro-inflammatory effect of the released antibiotic doses by more than tenfold. Full article

This study presents an open and replicable methodology for multi-lead ECG signal quality assessment (SQA), implemented on a 12-lead embedded acquisition platform. Signal quality is a critical software component for diagnostic reliability and compliance with international standards such as IEC 60601-2-27 (clinical ECG monitors), IEC 60601-2-47 (ambulatory ECG systems), and IEC 62304 (software life cycle for medical devices) which define the essential engineering requirements and functional performance for medical devices. Unlike proprietary SQA algorithms embedded in closed commercial systems such as Philips DXL™, the proposed method provides a transparent and auditable framework that enables independent validation and supports adaptation for research and clinical prototyping. Our approach combines convolutional neural networks (CNNs) with FFT-derived spectrograms to perform four-level signal quality classification (High, Medium, Low, and Unidentifiable), achieving up to 95.67% accuracy on the test set, confirming the robustness of the CNN-based spectrogram classification model. The algorithm has been validated on a custom controlled dataset generated using the Fluke PS420™ hardware simulator, enabling controlled replication of signal artifacts for software-level evaluation. Designed for execution on resource-constrained embedded platforms, the system integrates real-time preprocessing and wireless transmission, demonstrating its feasibility for deployment in mobile or decentralized ECG monitoring solutions. These results establish a software validation proof-of-concept that goes beyond algorithmic performance, addressing regulatory expectations such as those outlined in FDA’s Good Machine Learning Practice (GMLP). While clinical validation remains pending, this work contributes a standards-aligned methodology to democratize advanced SQA functionality and support future regulatory-compliant development of embedded ECG system. Full article

At present, there are some devices for muscle strength training after knee surgery, such as elastic bands and isokinetic muscle strength training instruments, but most of them are expensive or cannot monitor training progress. Triboelectric nanogenerators (TENGs) have proven to be reliable self-sensing devices. There have been some applications in the field of rehabilitation, but few have been used for muscle strength training. Our team has innovatively applied the TENG self-sensing device to the self-rehabilitation management of the knee joint post-surgery. We have developed the “Triboelectric Nanogenerator for Muscle Strength Training of Knee Joint after Surgery” (MSTKJS-TENG), which is significantly more integrated than traditional instruments (volume: 120 mm × 100 mm × 100 mm) and can real-time track the number and quality of movements completed by patients during muscle strength training. The development of this device has made up for the deficiencies of traditional instruments. It can assist medical staff in remotely evaluating the recovery of patients’ postoperative muscle strength to a certain extent, thereby adjusting training intensity in a timely manner and providing personalized guidance. Meanwhile, the research on this device provides effective technical support and innovation for the development of smart rehabilitation medicine. Full article

This research presents a cradle-to-grave Life Cycle Assessment (LCA) of a modern behind-the-ear hearing aid system, with the objective of assessing its environmental impacts and identifying areas for improvement and innovation. The assessment, developed in compliance with ISO 14040/14044, included the entire product system—including accessories, packaging, use phase, and end-of-life treatment—over a period of five years. The results provide an in-depth evaluation of its freshwater ecotoxicity, human carcinogenic toxicity, global warming, and fossil resource scarcity as key impact categories. Considerable environmental impacts were associated with certain components, manufacturing processes, and logistics. Strategies for improvement, including material replacement, increased component durability, packaging optimization, and sustainable sourcing of energy, were suggested. The investigation demonstrates how LCA can facilitate eco-design and sustainability in medical electronics. The findings of this work are derived from experimental modeling in an academic setting, which includes intrinsic uncertainties. The results emphasize the significance of using LCA as a strategic instrument to guide product development and to pinpoint opportunities for environmental improvement. Full article

This work presents the design and implementation of a mechanical test bench developed for the comparative evaluation of three configurations of a mechanical biomedical device: the reference version and two optimized alternatives aimed at improving long-term reliability and functional performance. The test bench performs mechanical fatigue testing under controlled and repeatable conditions, simulating the cyclic loads typical of real-world operation. A key innovation of this system is the integration of a non-invasive acoustic acquisition module, which continuously monitors the dynamic behavior of the device during testing. The analysis of acoustic signals allows for the early detection of wear, looseness, deformation, and the onset of structural defects, providing valuable insight into the device’s mechanical health without altering its configuration. This study also details the engineering design of the control system, emphasizing both hardware integration and software architecture supporting real-time signal processing. Experimental results demonstrate that acoustic analysis represents an effective non-destructive approach for evaluating the endurance and reliability of compact plastic biomedical devices. The proposed methodology contributes to more accurate service life estimation, supports product validation, and promotes continuous improvements in the safety and quality of mechanical systems used in biomedical applications. Full article

Biosensing technology serves as a cornerstone in biomedical diagnostics, environmental monitoring, personalized medicine, and wearable devices, playing an indispensable role in precise detection and real–time monitoring. Compared with traditional sensing platforms, functional nanomaterials—by virtue of their ultra–large specific surface area, exceptional optoelectronic properties, and superior catalytic activity—significantly enhance the sensitivity, selectivity, and response speed of biosensors. This has enabled ultrasensitive, rapid, and even in situ detection of disease biomarkers, pollutants, and pathogens. This review summarizes recent advances in five key categories of functional nanomaterials—metallic, semiconductor, carbon–based, two–dimensional, and stimulus–responsive materials—for advanced biosensing applications. It elucidates the structure–property relationships governing sensing performance, such as the surface plasmon resonance of gold nanoparticles and the high carrier mobility of graphene, and analyzes the core mechanisms behind optical sensing, electrochemical sensing, and emerging multimodal sensing strategies. With a focus on medical diagnostics, wearable health monitoring, and environmental and food safety surveillance, the review highlights the application value of functional nanomaterials across diverse scenarios. Current research is progressively moving beyond single–performance optimization toward intelligent design, multifunctional integration, and real–world deployment, though challenges related to industrial application remain. Finally, the review outlines existing issues in the development of functional nanomaterial–based biosensors and offers perspectives on the integration of nanomaterials with cutting–edge technologies and the construction of novel sensing systems. This work aims to provide insights for the rational design of functional nanomaterials and the cross–disciplinary translation of biosensing technologies. Full article

The increasing use of medical applications using mobile devices has led to increased concerns about data security. Mobile Edge Computing (MEC) is an emerging technology that can be used to improve end-user services, especially in medical applications that require low latency and high bandwidth. MEC provides a promising solution that brings data processing closer to the end user to process requests faster. In doing so, security concerns about communication links and MEC server faults become a problem for MEC architectures and the concerned applications. In this paper, we propose a secure and fault-tolerant mechanism for the Internet of Medical Things (IoMT) based on an MEC architecture in a Software-Defined Network. Then, we present a secure scheme that consists of four main steps. (1) Establishment of secure virtual private network connection to secure network communication, (2) monitoring of network traffic to detect threats, (3) application of intrusion prevention measures, and (4) updating of security rules to prevent future attacks. The fault-tolerant aspect is developed based on the Kubernetes cluster to avoid service disruption in case of faults on a given MEC server. The simulation results depict substantial improvements, including reduced latency, better workload equilibrium, increased achievable throughput, and reduced retransmissions between servers. Our proposed scheme is effective in detecting distributed denial of service attacks. Moreover, in the event of an MEC server fault, the service is not interrupted and the architecture continues to render optimal services. Full article

Background: The use of preservative agents in eye drop solutions may worsen symptoms of ocular surface disease, which is a highly prevalent syndrome worldwide. Preservatives are often used in pharmacotherapy of glaucoma, another disease concerning tens of millions of people around the globe. These numbers are predicted by the World Health Organization and are predicted to increase with time due to constant aging of populations. Methods: PubMed and Scopus databases were searched for articles investigating the topic of ocular surface disease in relation with glaucoma pharmacotherapy, according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The aim of this review is to summarize the effect of various solvents used in drug formulations and ways to quantify their impact on the ocular surface. Discussion and Conclusions: Topical ophthalmic preservative-free formulations are better tolerated and less burdensome for all patients. They should be considered especially for glaucoma patients, who are expected to take medications for years, up to decades or a lifetime in many cases. Due to the chronicity of dry eye disease and the lack of reliable ways for lacrimal and meibomian gland renewal, primary prophylaxis is of uttermost importance. Unfortunately, despite the development of many measuring devices, the standardization of diagnostic methods poses a challenge due to high variability of results which are influenced by a myriad of factors—local, internal, and external. Full article