Medical devices have been regulated by the Food and Drug Administration since 28 May 1976. The FDA does not currently require that medical device companies publish diversity data across all device approval pathways. Demographic information is imperative because it enables stakeholders to note the safety of medical devices with different demographic groups. The aim of this article is to quantify the demographic information publicly available on the FDA's 2023 Device Approvals page. The N = 52 medical devices available on the FDA's 2023 Device Approvals page were analyzed via qualitative coding with two coders and then checked for intercoder reliability using Cohen's Kappa. Of the medical devices on the webpage, only 59.6% reported all demographic variables included in the study (gender/sex, race, ethnicity, and age). Sex/Gender was reported 92.3% of the time, Race 75% of the time, Ethnicity 61.5% of the time, and Age 94.2% of the time. More stringent guidelines are needed for reporting demographic data with medical devices, which may lead to increased patient safety and personalized medicine.
Science, technology, engineering, mathematics (STEM) education is critical for fostering medical students' scientific research capabilities, innovative thinking, and interdisciplinary problem-solving skills, which are essential for adapting to technology-driven medical advancement. The aim is to construct a STEM competence assessment scale applicable to students majoring in clinical medicine in medical colleges and universities, and to investigate the current situation of students' STEM competence through this scale, so as to provide methods and tools for the improvement of STEM teaching in medical education. Through literature review and expert consultation, the dimensions and items of the scale were designed. Exploratory factor analysis, confirmatory factor analysis, root mean square error of approximationOf Approximation and Cronbach α coefficient were adopted to evaluate the reliability and validity of the scale. The finally constructed assessment scale encompasses 4 dimensions, namely knowledge, attitude, behavior and competence, with a total of 45 items in all. The survey results of 1010 students majoring in clinical medicine showed that the Cronbach α coefficient of the scale was 0.933, indicating good internal consistency. Confirmatory factor analysis demonstrated that the model had an excellent fit (χ2/df = 3.646, Root Mean Square Error Of Approximationroot mean square error of approximation = 0.051), and each dimension had relatively high structural validity. The STEM competence assessment scale developed in this research has relatively high reliability and validity, which can effectively reflect the comprehensive performance of medical students in STEM education, and provides an important tool for the evaluation of the effect of STEM education and the improvement of medical education.
Occipital-cervical (OC) fixation poses distinctive challenges due to unique craniocervical junction (CCJ) anatomy and a complex range of pathology leading to CCJ instability. There has been substantial evolution in modern OC fixation techniques since their introduction in the 1990s, each with implications on rate of fusion, range of motion, and ease of use. We performed a manual review of OC fixation techniques via a query of the National Library of Medicine MEDLINE database between 10 September and 1 October 2025. Categories of OC fixation included sublaminar wiring and bone graft, pre-integrated and modular plate-based constructs, non-plate-based screw-rod constructs, occipital condyle screws, and C1-occipital transarticular screws. Patient outcomes are comparable between modern plate-based and non-plate-based fixation systems, thus selection of technique is determined by surgeon preference, ease of use, and patient-specific anatomical considerations. Increasingly, modular plate-based and eyelet screw systems are gaining popularity due to their adaptability to varying anatomy, with poly-axial condylar and transarticular screws representing bail-out options in cases of suboccipital decompression or prior hardware failure due to the risk this technique poses to neurovascular structures. Future innovation may give rise to 3-D printed personalized implants for cases with complex anatomical or pathological considerations.
Medical device errors in Intensive Care Units (ICUs) position a critical threat to patient safety due to the complexity of devices, high patient alertness, and demanding clinical situations. Despite rising support on medical technologies, evidence on the nature of causes and prevention of device-oriented errors in ICUs remains fragmented. The PRISMA guidelines were followed throughout the systematic review, and the review was registered in PROSPERO (CRD42023424716). Studies published between 2010 and 2025 were accounted through 17 databases. The studies on medical device errors in adult, pediatric, and neonatal ICUs were encompassed, and the outcomes were synthesized qualitatively. Seventy-two studies were covered and infusion pumps, syringe pumps, ventilators, and monitoring equipments were majorly associated with medical device errors. Errors were primarily related with human factors, device design flaws, and system failures. Infusion pump errors occurred in 60% of infusion initiations (80,209/133,601), while 89% of arrhythmia alarms were false positive among 2.5 million monitor alerts recorded in a cohort of 461 ICU patients. Medical device errors in ICUs are multifactorial. Effective prevention requires integrated approaches encompassing human factors engineering, focused training, improved device design, and a strong resilient patient safety culture.
This scoping review mapped common specifications, standards and overlapping regulations for high-risk and innovative medical devices (MDs) and in vitro diagnostic medical devices (IVDs) in the European Union (EU), United States (US) and China to clarify compliance pathways and support regulatory harmonization. Following Joanna Briggs Institute (JBI) and PRISMA-ScR guidance, we searched PubMed, Scopus/Embase and Web of Science for studies on MD/IVD regulation, standards and common specifications in the aforementioned territories. Eligible records were screened in two stages, with data extracted using a structured form and synthesized narratively by regulatory pathway, standards, common specifications, and guidelines. Of 3093 records identified, 2262 were screened and 275 met inclusion criteria. Across jurisdictions, regulation converges on risk-based classification, lifecycle clinical evidence, quality management and post-market surveillance. Differences persist in evidentiary thresholds, implementation timelines, regulator/notified-body capacity and requirements for software, Artificial Intelligence (AI), laboratory-developed tests and local testing, which are particularly challenging for Small and Medium Enterprises (SMEs). Regulatory frameworks in these territories are aligned in principle but variably specified and implemented, creating complexity for global market access. Clearer guidance on common specifications, explicit expectations for emerging technologies and harmonized post-market evidence requirements may reduce duplication while maintaining patient safety.Protocol registration on OSF (www.osf.io), identifier is 10.17605/OSF.IO/5JEX8.
The fusion of Artificial Intelligence and Machine Learning in the context of healthcare informatics has opened up revolutionary improvements with the help of applications in Artificial Intelligence-powered NLP (Natural Language Processing). The algorithms are designed and developed by artificial intelligence and are utilized to conduct comprehensive analysis within medical data, and they improve medical decisions. Within this revolutionary scenario, the mental healthcare (MHC) chatbots based on NLP bring about revolutionary improvements in processing large-scale complex medical information. In this narrative review, the structured literature review has been carried out on diversified databases like Scopus, PubMed, Web of Science, IEEE Xplore, and Google Scholar for published articles during the time frame of 2017 to 2025. The framework, algorithms, performance measures, and SWOT analysis of NLP-based medical chatbots are examined to showcase the capabilities with existing limitations in revolutionizing healthcare informatics. The NLP chatbots help facilitate real-time therapy sessions, support the scheduling of appointments, and generate timely responses more easily. However, with a structured architectural framework provision to address the safety and effectiveness concerns, these chatbots can be more responsible in real-world applications.
Distraction osteogenesis is a fundamental surgical intervention for patients with complex craniofacial conditions such as syndromic craniosynostosis, mandibular micrognathia, and midface hypoplasia. Yet, its clinical implications continue to rely on empirical protocols lacking quantitative biomechanical foundations. In this review, we present a comprehensive synthesis of the current literature on force, torque, viscoelastic soft tissue resistance, and regenerate mechanics during craniofacial distraction osteogenesis based on a comprehensive literature search on PubMed, Scopus, Web of Science, Embase, and Google Scholar. Across cranial, maxillary, and mandibular distraction, we identified pronounced regional heterogeneity in mechanical demands, with cranial vault distraction requiring far greater torque and force than either maxillary or mandibular distraction. Importantly, the magnitudes of force and torque measured across the craniofacial skeleton are substantially lower than those presumed to guide current distractor engineering, revealing a significant opportunity for miniaturized, fully-internalized bioresorbable systems. We established a quantitative framework for a mechanobiologically optimized craniofacial distraction, providing the conceptual and engineering basis for anatomy-specific, feedback-regulated, next-generation distraction devices and patient-tailored distraction protocols.
Optical and video stylets are increasingly important airway management devices that combine real-time visualization with a slim rigid or semi-rigid design. They facilitate tracheal intubation in anatomically constrained airways while minimizing cervical spine movement and mouth-opening requirements. This narrative review examines the evolution, technical principles, classification, clinical applications, safety profile, and future developments of optical and video stylets. A structured literature search of PubMed/MEDLINE, Embase, and the Cochrane Library was conducted for publications published between January 1990 and January 2026. Randomized controlled trials, observational studies, systematic reviews, meta-analyses, and relevant international guidelines were prioritized. Video stylets have progressively replaced optical systems because of superior image quality, ergonomics, and training utility. Their greatest value lies in anatomically constrained airways and as complementary tools within multimodal airway management strategies. Persistent limitations, particularly lack of suction capability and sensitivity to contamination, support their role as adjuncts rather than universal airway devices.
The complications associated with the use of transvenous leads and device pockets have been a major drawback in the use of traditional cardiac implantable electronic devices. Infections, venous obstruction, and problems in device extraction have been some of the issues. Leadless pacing systems and extravascular implantable cardioverter defibrillator have been developed to overcome some of the issues. A narrative literature review was performed on the available literature using the PubMed/MEDLINE, Embase, and Google Scholar databases to search for relevant studies published between January 2000 and January 2026. Clinical trials, registries, and observational studies assessing the performance, complications, and patient selection for these devices were reviewed. The current literature shows high success rates of implantation, low infection risk, and efficacy of defibrillation and pacing with these devices, although challenges exist in the form of battery life, incomplete cardiac resynchronization, and the strategy of device succession. Leadless and extravascular cardiac rhythm management systems are a significant move toward reducing complications associated with leads and maintaining vascular access. The future use of these systems will depend on advancements in device longevity, pacing functions, cost effectiveness, lifetime device management, and evidence that reductions in lead and pocket related morbidity are not offset by new long-term management burdens.
Focal osteochondral defects of the knee represent a significant clinical challenge due to pain, functional impairment, and the risk of early osteoarthritis. Conventional cartilage repair techniques may provide satisfactory results in selected patients but are often limited by donor-site morbidity, multistage procedures, and inconsistent long-term outcomes. Recent advances in biomaterials and tissue engineering have led to the development of osteochondral implants designed to restore the entire osteochondral unit and improve functional recovery. This narrative review summarizes the current literature on the most widely investigated osteochondral implants for the treatment of focal knee defects, including AMIC with Chondro-Gide, MaioRegen, Agili-C, and focal metal resurfacing implants. The available clinical evidence was analyzed with particular attention to implant design, surgical indications, clinical outcomes, and complications. In addition, recent technological developments and the main challenges affecting implant integration and durability were examined. From an expert perspective, current implants show encouraging short- and mid-term clinical outcomes, but none has yet emerged as the standard of care. Future research should focus on long-term comparative studies, improved patient-selection strategies, and technological innovations aimed at optimizing osteointegration, durability, and defect-specific treatment.
With the increasing requirements for performance and safety of lower limb exoskeleton rehabilitation robots, researchers are exploring various active compliance control strategies to improve the compliance of control and enhance safety and effectiveness of rehabilitation training. The focus of this paper is to evaluate existing active compliance control strategies applied to lower limb exoskeleton rehabilitation robots, highlighting their principles, key technologies, and performance. Literature searches were conducted in PubMed and Web of Science from 2000 to 2025, starting with the broad keyword 'active compliance control strategy' and narrowing down to specific aspects such as 'impedance control'. Sixty-nine articles were reviewed, and eight active compliance control strategies were divided into three categories according to their core principles: impedance control (n = 18), force, and position hybrid control (n = 27) and machine learning-based hybrid control (n = 24). Their applications in five types of lower limb exoskeleton rehabilitation robots are outlined. Active compliance control strategies for lower limb exoskeleton rehabilitation robots are necessary for safe human-robot interaction and assist-as-needed implementation. This paper envisions the concept of an active compliance controller that covers the entire rehabilitation cycle, ensuring that the robot is continuously aligned with the patient's rehabilitation needs.
We characterized regulatory and safety patterns of FDA 510(k)-cleared chronic pain devices over five decades. We analyzed 1718 chronic pain devices cleared from 1976-2025, assessing device modality, review times, recalls (2002-2025), and market concentration (Herfindahl - Hirschman Index, HHI). Most devices were noninvasive neuromodulation (1,486 [86.5%]), followed by invasive neuromodulation (162 [9.4%]), energy-based (67 [3.9%]), and digital therapeutics (3 [0.2%]). Median FDA review was 117 days (IQR, 69-220) - shorter for invasive (90 days; IQR, 42-156) than noninvasive neuromodulation (120 days; IQR, 70-222). US-origin devices declined from 97.6% (1976-1985) to 43.1% (2016-2025). Invasive devices declined 45% from peak (12.3%, 1996-2005) to 6.7% (2016-2025), while digital therapeutics emerged post-2016. Among 843 devices evaluated for safety, invasive devices had 14-fold higher recall rates than noninvasive (100 vs. 7.1 per 1000); median time to recall was 3.9 years (IQR, 2.9-4.7). Market concentration differed markedly: invasive devices highly concentrated (HHI, 3710; single manufacturer 58%) versus fragmented noninvasive markets (HHI, 43). Despite shorter regulatory review, invasive chronic pain devices demonstrated substantially higher recall rates. The shift toward globally sourced noninvasive technologies reflects evolving regulatory-technological considerations.
Chemotherapy, while effective, can damage blood vessels due to repeated punctures and drug irritants, leading to complications like tissue damage from infiltration, clots, and phlebitis. To reduce these risks and improve patient comfort, venous catheters such as centrally inserted access ports (PORTs) and peripherally inserted central catheters (PICCs) are commonly used. This study systematically reviewed and analyzed clinical and economic data comparing PORTs and PICCs in adult chemotherapy patients, considering randomized trials, observational studies, and cost-effectiveness analyses. Data on complications and costs were extracted, and meta-analyses were conducted. Risk of bias was also assessed. Sixty-three studies were included. PORTs showed significantly lower rates (per 1000 catheter-days) of thrombosis, local infections, and catheter malposition compared to PICCs. Similar trends were seen for wound complications and mechanical issues. Economic analyses favored PORTs for cost-effectiveness. Study limitations included heterogeneity and potential bias, though overall quality was moderate to good. Findings support the clinical and economic value of PORTs for long-term chemotherapy, difficult venous access, and low-maintenance needs, whereas PICCs suit shorter treatment durations, patients unsuitable for minor surgery, or settings favoring bedside insertion. Decisions should align with the goals of the European Health Technology Assessment Regulation to harmonize medical device evaluation across Europe.
Leprosy remains a major public health challenge in countries like India, Brazil, and Indonesia. The materiovigilance program was established to monitor the safety of medical devices and helps to protect health-care workers and patients from device-related injuries. Leprosy patients suffer from sensory loss and are at high risk of developing injuries with medical devices. Therefore, integrating materiovigilance program with the national leprosy care program is essential to improve the safety and wellbeing of leprosy patients. This critical perspective covers the role of materiovigilance in India, the classification of medical devices based on their risk status, devices used in leprosy management, the Indian and international target goals for leprosy elimination, and emphasis on the integration of materiovigilance programs with leprosy programs in leprosy treating hospitals. There is a significant gap existing in the leprosy elimination policies regarding the safety concerns with the use of medical devices. Successful integration of materiovigilance framework with leprosy elimination policies will influence the treatment outcomes in a positive manner. The key challenges to overcome are lack of awareness, training, and funding. Implementing the integration strategy in a stage-wise manner will help to identify the lacunae, operational issues, and further strengthen the program.
Digital health interventions using wearable devices and mobile health (mHealth) applications are increasingly used to promote health-related behaviors. However, direct comparative evidence between these modalities remains scarce. To conduct an exploratory comparative (scoping-style) systematic review synthesizing direct evidence comparing wearable-based versus app-only behavioral monitoring tools, with emphasis on hypothesis generation rather than comparative effectiveness. A systematic search was conducted following PRISMA 2020 guidelines. Two studies met inclusion criteria: one population-based observational cohort and one secondary analysis of a randomized controlled trial. Risk of bias was assessed using ROBINS-I and RoB 2.0, and certainty of evidence using GRADE. Evidence was limited and heterogeneous, precluding meta-analysis. Wearables demonstrated higher adherence and sustained data transmission (low certainty), while app-only interventions showed similar or slightly greater improvements in specific behaviors such as walking practice (very low to low certainty). No robust evidence supported equivalence or superiority of either modality for overall health or metabolic outcomes. Direct comparative evidence between wearable-based and app-based monitoring tools is extremely limited. Findings should be interpreted as hypothesis-generating rather than confirmatory. Future adequately powered head-to-head trials are required.
Epilepsy is recognized to be a significant cause of premature mortality, socio-economic distress and poor quality of life in economically developed countries. Despite clear clinical guidelines, epilepsy care is marked by delayed diagnosis, fragmented management, high emergency admission rates, and pronounced health inequalities affecting rural populations, ethnic minority groups, and people with intellectual disabilities. Diagnostic pathways remain inefficient, with prolonged waits for electroencephalography (EEG), low sensitivity of routine investigations, and repeated inconclusive testing. Long-term management continues to depend on infrequent hospital visits and unreliable patient recall, contributing to suboptimal seizure control, avoidable morbidity, and preventable mortality. In the United Kingdom, epilepsy affects over 630 000 people, accounts for approximately £2 billion in annual healthcare costs and exemplifies these systemic failures. Current hospital-centric care models are failing to meet their complex, often lifelong, needs. In its recent 2025 "Fit for the Future" 10-year plan, the UK government mandates three fundamental shifts in healthcare: from hospital to community, analogue to digital, and sickness to prevention. Epilepsy diagnosis and care exemplify the potential for this comprehensive triumvirate transformation, with emerging technologies including point-of-care EEG systems, AI-powered diagnostics, wearable devices, and digital therapeutics offering unprecedented opportunities to deliver specialist-level care in community settings and reduce illness burden. However, successful implementation requires addressing digital exclusion risks for vulnerable populations. We propose that technology-enabled community epilepsy care can serve as a blueprint for the UK's National Health Service (NHS) transformation while delivering immediate benefits for patients, families, and healthcare systems. The convergence of clinical need, technological capability, and policy imperative creates a unique opportunity to move beyond incremental improvements to fundamental system redesign that ensures equitable access to high-quality epilepsy care across all communities. Such a model, if delivered, could be an exemplar for other chronic conditions both in the United Kingdom and globally. PLAIN LANGUAGE SUMMARY: Current epilepsy care in the United Kingdom often involves long waits and relies on infrequent hospital visits, which is not ideal for a lifelong condition. New technologies, such as wearable devices and AI-powered tools, offer a chance to change this. By moving care from hospitals into the community, we can provide faster diagnosis, continuous monitoring, and more personalised support. This will help improve the lives of the 630 000 people with epilepsy in the UK, ensuring they receive better, more accessible, and more equitable care.
Ablation for rhythm control of atrial fibrillation originated in the 1990s and has been dominated by thermal ablation techniques such as radiofrequency ablation and cryoballoon ablation. However, more recently, pulsed field ablation has offered a cutting-edge nonthermal technique that minimizes the complications previously seen in thermal ablation. We present a review of the existing literature regarding pulsed field ablation for atrial fibrillation. We provide an overview of the history of ablation techniques, the mechanism of pulse field ablation, and procedural characteristics of pulse field ablation. We also present both short-term and long-term outcomes of the procedure in addition to an overview of possible complications. It is the authors' opinion that pulsed field ablation represents an exciting ablation technique for the treatment of atrial fibrillation that has a minimal learning curve for those already experienced in thermal ablation techniques. It also demonstrates noninferior, and in some cases superior, outcomes in comparison to thermal ablation and has fewer complications. Further studies are needed to evaluate long-term outcomes and complications past one-year post ablation.
Peripherally inserted central catheters (PICCs) are commonly used in clinical practice. Historical PICC placement methods (e.g. fluoroscopy-guided placement or blind insertion with confirmatory chest X-ray) have many limitations and are associated with longer wait times, treatment delays, and potential risks to patient safety. One such way of addressing some of these issues is the use of dedicated systems that integrate ultrasound vessel selection and PICC insertion, magnetic catheter tip navigation, and intracavitary electrocardiogram-based tip confirmation (IC-ECG). The uptake of these systems has been slow in some parts of the world. This narrative review aims to assess the clinical and economic value of an integrated IC-ECG based tip confirmation system for PICC placement. This review article will focus on the scientific literature discussing the bedside application and benefits of an IC-ECG-based tip confirmation system (Sherlock 3CG™), specifically for PICC placement. These systems can be associated with greater efficiency, improved safety outcomes, fewer exposures to ionizing radiation from fluoroscopy and X-ray confirmation, shortened procedure times, and increased procedural accuracy when compared with other historical methods. Based on this review, the authors found that an IC-ECG based tip confirmation system can offer safe, effective, and cost-saving bedside PICC placement compared to conventional PICC placement methods.
Inspiratory muscle training (IMT) is a potential adjunct therapy to improve inspiratory muscle strength and endurance, exercise capacity, health-related quality of life (HRQL) and symptoms in chronic lung diseases. A growing number of IMT devices are commercially available; however, their mechanisms, utilization, and supporting evidence vary. This narrative review summarizes IMT devices used in chronic lung diseases, including threshold trainers, flow-resistive devices, and isocapnic hyperpnea devices. A PubMed search to February 2026 identified studies that tested commercially available IMT devices in chronic lung disease and described their mechanism, usability and their efficacy or effectiveness. Manufacturer websites also provided device-specific information. Factors that influence IMT outcomes are described including: training intensity, duration, frequency, patient selection, and practical considerations. IMT is a feasible intervention that improves inspiratory muscle strength and exercise capacity, commonly improving respiratory symptoms and HRQL. Device type (pressure-threshold versus flow-resistive) and practical factors, including cost, usability, supervision, and feedback capabilities may influence both training load and clinical response. Future directions include perioperative IMT as a prehabilitation strategy, the potential role of respiratory muscle memory, and the development of digital and artificial intelligence-enhanced IMT devices.
The development of hand exoskeletons for the assistance and rehabilitation of dexterity impairments has been ongoing for decades, although advancements are hindered by inconsistent evaluation metrics. This review aims to identify all methods used to test and compare the devices. Using these, it outlines an evaluative framework to standardize research and reduce heterogeneity moving forward. Literature from 2010 to 2025 was searched for using Scopus, IEEE Xplore, and PubMed. This comprised of publications detailing each exoskeleton and overall reviews of the technologies. Current testing methods were identified within mathematical and computational modeling, non-clinical prototype testing, clinical feasibility trials, and rehabilitative trials. At present, clinical adoption of hand exoskeletons is limited due to the lack of thorough, methodical analysis. The variation of assessment methods is partially attributed to the absence of suggested guidelines but may also be driven by intentions to mask device limitations. The current practices for theoretical analyses are sufficient for design optimization, verification, and defining control systems. However, both non-clinical and clinical prototype testing are used to validate device performances; therefore, the suggested standardized protocols would improve inter-device comparisons. This would produce faster advancements, leading to improved rehabilitation outcomes and patient independence.