Frontiers in medical technology最新文献

Background: Uncontrolled hypertension is common in chronic kidney disease (CKD) patients. Electro-hydraulic acoustic therapy (eHAT) is a non-invasive treatment that may lower blood pressure (BP), but its safety and efficacy in CKD remain unclear. This study aimed to evaluate eHAT's feasibility and safety in this population.

Methods: In this single-arm, prospective, single-center proof-of-concept study, CKD patients received six eHAT treatments over three weeks. BP was assessed in-office (attended and unattended) at baseline and at 4-, 12-, 24-, and 48-weeks post-treatment. Ambulatory BP monitoring (ABPM) was performed at baseline, 12, and 48 weeks. The primary endpoint was change in systolic office BP (OBP) from baseline to 12 weeks. Secondary endpoints included additional BP measurements, kidney function, and safety.

Results: Fifteen patients completed all follow-ups. At 12 weeks, mean systolic OBP decreased by 9.73 mmHg (SD 14.77; p = 0.0032) and remained significantly lower at 24 weeks (-7.67 mmHg; p = 0.0335) and 48 weeks (-19.40 mmHg; p < 0.0001). Diastolic OBP reductions were significant at 12 (p = 0.0413) and 48 weeks (p = 0.0022). By 12 weeks, 26% of participants reduced the number or dose of antihypertensive medications. Kidney function remained stable throughout. No safety signals were detected.

Conclusion: Our study highlights the feasibility and tolerability of eHAT in patients with CKD and HTN. Nonetheless, due to the small sample size and lack of a control group, these findings should be considered preliminary.

Conventional ocular drug delivery systems are often limited by low bioavailability and short residence times at the ocular surface, motivating the development of alternative delivery platforms. In this study, vitamin C-loaded contact lenses were prepared using a simple soaking technique and systematically evaluated. Two commercial lenses, Senofilcon A and Hilafilcon B, were immersed in vitamin C solutions, and their loading efficiency, release kinetics, stability, water content, and oxygen permeability were investigated. Vitamin C release was quantified using UV-Vis spectrometry and analyzed using zero-order, first-order, Higuchi, and Korsmeyer-Peppas models. Hilafilcon B exhibited higher vitamin C loading and cumulative release (∼14 µg/mL) than Senofilcon A (∼10 µg/mL), consistent with its higher hydrophilicity and equilibrium water content (∼56% compared to ∼29%). Kinetic analysis indicated that the vitamin C release from both lenses was best described by the Korsmeyer-Peppas model (Hilafilcon B, n = 0.610; Senofilcon A, n = 0.783), suggesting anomalous transport behavior. Vitamin C stability was strongly influenced by storage conditions, with refrigerated storage improving stability, while UV exposure accelerated degradation. Overall, these findings demonstrate that vitamin C incorporation via soaking provides a straightforward approach for developing antioxidant-loaded contact lenses with potential relevance for ocular drug delivery.

Introduction: The promise of precision medicine lies in its ability to provide greater diagnostic accuracy and customized therapy by filtering out patients less likely to benefit from it. Our study focuses on the importance of reducing uncertainty in interpretation of individuals 3D facial data to support more equitable precision medicine applications. The Human Genome Project and subsequent advances in sequencing have led to the creation of vast genetic datasets, predominantly representing individuals of European origin. However, there is a significant underrepresentation of individuals of African, Asian, and Indigenous ancestries.

Methods: The study involved 1,218 participants from various genetic ancestries backgrounds, with a focus on the paediatric population of Chinese genetic ancestry. The study subjects underwent 3D facial photogrammetry in outpatient department setting and with the aid of Cliniface software growth curves were obtained to produce reference statistics of 3D facial norms.

Results: The results showed measurable and distinct facial differences in children with Chinese genetic ancestry when compared with other groups representing different genetic ancestries highlighting the need for population diversity and inclusion enrichment in genetic databases. Also, these facial differences and markers are uniquely poised to be correlated in clinic as disease specific digital biomarkers with further investigation and validation in conditions such as hereditary angioedema.

Discussion: The study underscores the importance of creating larger datasets involving more diverse genetic ancestry groups to enhance the evidence base for advanced and equitable disease diagnosis, treatment monitoring, prognostication and customized drug development.

Background: Early access programs (EAPs) can provide patients with medical devices before full market access in urgent or high unmet-need situations. Unlike pharmaceuticals, the European Union (EU) has no harmonised early-access framework for medical devices, resulting in fragmented national practices. We use EAP as an umbrella term for two overlapping categories with distinct objectives: (1) early access in the strict sense, authorising exceptional pre-market use under defined conditions; and (2) accelerated access, aiming to shorten time to routine access by streamlining regulatory, reimbursement, or evidence-generation pathways. We map and compare these mechanisms across the 27 EU Member States (MS).

Methods: We conducted a qualitative document-based analysis of peer-reviewed literature, grey literature (policy papers, regulatory guidance), and legal sources (EU legislation, national laws) published up to June 2025. We searched PubMed and Google Scholar, consulted Eur-Lex, and reviewed national competent authority websites. Search terms (English and local languages, then translated) combined "medical device" with "early access," "accelerated access," "compassionate use," and "derogation," plus "EU" or MS names. Documents were included if they described mechanisms enabling early use of medical devices. We synthesised and compared key program characteristics.

Results: We identified early and accelerated access pathways at EU level and within MS. EU law provides derogations from CE-marking requirements, notably Article 59 of the EU Medical Device Regulation (EU MDR), allowing national authorisation of non-CE-marked devices in exceptional circumstances. The EU MDR also enables the use of custom-made devices and certain in-house manufactured devices by health institutions without full CE marking. Nationally, at least half of MS operate compassionate or expanded access schemes for devices, and some implement reimbursement or evidence-development mechanisms (e.g., France's forfait innovation) to support early use while generating decision-relevant data.

Conclusions: Early access to medical devices in Europe relies on EU regulatory derogations and heterogeneous national schemes. The landscape remains fragmented and unevenly documented. We recommend: (1) a more structured EU-level route for high-risk and combination products, (2) lifecycle-based national schemes integrating regulatory and payer access, (3) measures to reduce inequities and administrative barriers, particularly in Central and Eastern Europe, and (4) improved transparency and standardised data collection on implemented pathways.

Keratinocyte stem cells (KSCs) are the principal drivers of epidermal renewal, barrier maintenance, and wound repair. Their ability to alternate between self-renewal and differentiation is orchestrated by tightly integrated extrinsic and intrinsic programs that ensure tissue stability while enabling rapid regeneration after injury. This review synthesizes current understanding of KSC homeostasis through a unified framework of three interdependent "fate locks"-the identity switch (ΔNp63 ↔ Notch/IRF6-KLF4/GRHL3/OVOL), the cell-cycle lock (E2F/MYC ↔ p21/p27-RB), and the mechanotransduction lock (YAP/TAZ ↔ Hippo/LATS). We summarize how niche-derived cues-integrins/ECM, EGFR, Wnt, Notch, Ca^{2 +}/CaSR, and TGF-β-interface with intrinsic timers such as asymmetric division, DNMT1-UHRF1-mediated epigenetic memory, the DNA-damage response, proteostasis/autophagy, and redox signaling to steer keratinocyte fate. Building on this biological foundation, we categorize current methods for isolation and xeno-free expansion of primary human keratinocytes, emphasizing advances in defined media, feeder-free substrates, and biomimetic culture surfaces. We further review 3D and organotypic models, hydrogel-based delivery systems, and the growing portfolio of keratinocyte-derived clinical products used in wound healing. Finally, we highlight emerging applications extending beyond cutaneous repair-including immunomodulation, pigment restoration, ocular and mucosal regeneration, and acellular exosome-based therapeutics.

Background: Correct technique during strength exercises such as squats and Romanian deadlifts (RDLs) is fundamental for performance and injury prevention.

Objective: We introduce ADA (Anthropometry and Diagnostic Aware), a multimodal deep-learning framework that integrates IMU kinematics with anthropometric and diagnostic features to classify movement quality and predict movement related risk.

Methods: Seventeen-sensor IMU data were collected from 15 healthy subjects performing correct and incorrect squat and RDL trials. A CNN-LSTM branch processed kinematic sequences and a fully connected branch processed static anthropometric/diagnostic inputs; feature fusion used attention weighting.

Results: Incorporating anthropometry and diagnostic context increased sequence-level accuracy from 86.5% (kinematics only) to 94.8% (ADA) and enabled binary risk prediction at 97.8%. Personalized (transfer learning) fine tuning further improved accuracies (mean gains 3%-5% depending on window length).

Conclusion: ADA demonstrates that subject-specific static features improve movement quality classification and risk stratification, supporting wearable-based personalized feedback in training and rehabilitation.

Surface-induced thrombosis remains a significant limitation of blood-contacting medical devices, driven primarily by platelet activation and rapid clot formation. Nitric oxide (NO), a potent endogenous antiplatelet agent, has therefore inspired the development of targeted NO-delivery strategies to mitigate device-associated thrombosis. In this study, nitric oxide-releasing antiplatelet lipid nanoparticles (anti-PLT LNPs) were formulated and characterized for their physicochemical properties and NO-release kinetics. Their platelet aggregation inhibition was evaluated in vitro, while mammalian cell biocompatibility and effects on whole-blood coagulation were evaluated using activated clotting time (ACT) measurements. Anti-PLT LNPs exhibited sustained and measurable NO release after 22 weeks of storage and demonstrated high mammalian cell biocompatibility. The nanoparticles inhibited platelet aggregation by up to 84.4% (p < 0.01) and significantly prolonged whole-blood clotting time, resulting in up to a threefold increase in ACT (p < 0.05). These findings indicate that NO-releasing anti-PLT LNPs effectively suppress platelet activation and coagulation while maintaining biocompatibility, offering a customizable and targeted approach to mitigate surface-induced thrombosis in blood-contacting medical devices.

This technical note presents a standardized method that integrates intravascular laser irradiation of blood (ILIB) with infrared thermography to visualize real-time physiological responses during treatment. One adult male with long-standing type 2 diabetes underwent ten ILIB sessions using a 660 nm transcutaneous laser applied over the left radial artery. Infrared thermography captured temperature changes in abdominal regions associated with metabolic function. Across sessions, an average temperature increase of approximately 2.1 °C was observed in the hepatic and epigastric areas. Laboratory values showed reductions in fasting glucose (-29%) and HbA1c (-14%), while C-peptide remained stable. Because this is a single-patient technical demonstration, the findings cannot be interpreted as evidence of efficacy. Instead, the report illustrates the feasibility and potential utility of combining ILIB with thermal imaging for methodological development in future controlled studies.

The efficacy of wayfinding systems in healthcare settings holds significant implications for many users, including patients, visitors, and healthcare professionals. Traditional systems, anchor examples in spatial design principles, frequently overlook the variegated needs of individuals, especially those with physical and mental disabilities. This narrow focus culminates in a one-size-fits-all approach that fails to address the intricate diversity of user requirements, thereby compromising sensory spatial information that aids a user's real-time neurophysiological needs. To rectify this, the narrative review paper reviews the potential contribution of the ecology of wayfinding for understanding healthier wayfinding solutions. It proposes a paradigm shift towards a user-centric wayfinding model in healthcare facilities. Building on a nuanced understanding of the diverse needs and neurological factors affecting healthcare users, this paper describes and synthesises elements that adapt to the triangulation from the Human Activity Accessible Technology, (HAAT) to understand hospital users' wayfinding needs at a temporal to spatial level. Lastly, anticipating the novel conceptual framework to be considered a curb-cut effect for a therapeutic, user-based wayfinding system, beyond the assistive technology phenomenon. Adopting a humanistic lens, the framework aims to elevate the well-being and comfort of users by incorporating inclusion criteria into digital wayfinding systems. The paper concludes by identifying areas for future research to integrate user-based real-time capabilities into healthcare wayfinding technology, thereby aligning therapeutic objectives with an inclusive and supportive healthcare environment.

Background: Mechanical thrombectomy using stent retrievers is a proven treatment for large vessel occlusion stroke, but quantitative and objective evaluation of device-thrombus interaction remains limited.

Objective: This study introduces a novel algorithm and experimental framework to visualize and quantify thrombus deformation during retrieval under standardized in vitro conditions, with the long-term goal of informing future clinically applicable analysis tools.

Methods: An in vitro model simulating large vessel occlusion was developed using organized human thrombi. Two stent retrievers - the Embotrap III (6.5 × 45 mm) and NeVa (4.5x 29 mm) - were studied in a vascular model under fluoroscopic guidance. An algorithm was developed to automatically segment and quantify thrombus deformation and analyze contour changes during the retrieval.

Results: In total, 36 and 47 thrombectomies were performed with the Embotrap III and NeVa, respectively. Both devices achieved high first-pass reperfusion rates (Embotrap III: 88.9%, NeVa: 87.2%). However, thrombus deformation (mean: 14.7 × 10^-3 vs. 8.9 × 10^-3) and contour change (mean: 0.52 vs. 0.40) were significantly higher with Embotrap III, suggesting greater mechanical engagement. Thrombus fragmentation occurred in 5.6% of Embotrap III cases, but in none with NeVa. Moderate to marked distal thrombus migration occurred in over half of cases in both groups. Extensive migration occurred exclusively with NeVa in 4 cases (13%). Interrater and intrarater reliability of the automatic segmentation were excellent.

Conclusions: Our new imaging and analysis framework allows for objective, reproducible measurements of thrombus-stent interaction over time. Our findings support the high efficacy of both stent retrievers. While the Embotrap III exerted stronger mechanical deformation effects on the clots, initial distal thrombus migration occurred more often with the NeVa device. This approach may support more informed device selection and optimization of thrombectomy strategies to enhance reperfusion success and reduce distal embolization in acute ischemic stroke.