Expert review of medical devices最新文献

Introduction: The global health burden of pneumothorax is rising. Persistent air leak (PAL) from pneumothorax is a major driver of morbidity, prolonged hospitalization, and healthcare cost. Endobronchial valves (EBVs) are increasingly used as a minimally invasive treatment option for PAL based on limited evidence.

Areas covered: This review examines published evidence on clinical effectiveness in reducing/stopping air leak, and the risks and limitations on EBV use in management of PAL. A targeted search of PubMed from database inception to December 2025 was performed, and reference lists of key publications were screened. Relevant recommendations from current clinical guidelines are summarized.

Expert opinion: Evidence supporting the use of EBV in PAL is limited to case series/reports in which EBV appears effective in selected patients, often as a 'last resort.' Successful use of EBV requires expertise in patient selection, valve placement and their aftercare. EBV is expensive and has recognized risks. Its efficacy, safety and generalizability to unselected PAL patients are yet to be determined. Early phase clinical trials are underway to gather data to inform future definitive studies. As it stands, EBV remains an available option with limited evidence base, alongside autologous blood patch and chemical pleurodesis, for patients with PAL unsuitable for surgery.

Introduction: In recent years, the long peripheral catheter (LPC) has been introduced into clinical practice, filling the gap between short peripheral catheters and midline catheters. Heterogeneous nomenclature has created ambiguity regarding clinical outcomes.

Methods: A systematic search of CINAHL, Cochrane Library, Google Scholar, and PubMed (2000-2023) identified studies evaluating Accelerated Seldinger Technique (AST) placed LPCs in adults with difficult intravenous access (DIVA). Only Prospective and retrospective studies were included. Data extraction and quality assessment was independently performed by two authors.

Results: Eleven studies reporting 1871 catheter placements were included, comprising eight retrospective studies, one pilot RCT, and two RCTs. Mean LPC dwell time ranged from 2.92 (±0.54) to 17.1 (±12.3) days. Reported complications included infiltration (0-24%), dysfunction (3.6-15.7%), thrombosis (0.5-15.4%), infection (0-10.2%), occlusion (0.5-10.2%), and phlebitis (0.7-9.8%). Ten studies were rated low quality and one moderate, mainly due to selection bias and inconsistent outcome reporting.

Conclusion: This systematic review found a moderate number of catheter-related complications for AST-placed LPCs. In patients with DIVA, AST-LPCs may provide a potentially more durable option compared with short peripheral catheters, although the evidence is limited by inconsistent reporting of therapy completion and catheter outcomes.

Introduction: Computational modeling of cochlear implant stimulation has a long history, but its development has mostly been restricted to generic models, with patient-specific modeling being relatively rare, in spite of its potential applications in both research and clinical practice.

Areas covered: The present state of computational cochlear implant models is discussed in relation to patient-specific modeling. From three-dimensional geometries derived from clinical imaging to full end-to-end models of the electrically stimulated peripheral auditory system, computational cochlear implant models have progressed to the point where they can meaningfully simulate responses to complex (speech) stimuli.

Expert opinion: The development of patient-specific models that could be used to study the underlying mechanisms of cochlear implant functioning and ultimately be applied to make clinical diagnoses and recommendations, is within reach. However, there are still obstacles to overcome; the most immediate of these is the issue of auditory neural health, which is currently impossible to definitively assess in a living subject, yet has profound effects on electrical stimulation.

Background: We characterized regulatory and safety patterns of FDA 510(k)-cleared chronic pain devices over five decades.

Research design and methods: 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).

Results: 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).

Conclusion: 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.

Introduction: Obstructive sleep apnea (OSA) is known to impair quality of life (QoL) directly and through related symptoms and comorbidities. Continuous positive airway pressure (CPAP) is an effective therapy for alleviating OSA, resolving OSA-related symptoms, and improving the QoL.

Areas covered: We describe the literature about impairments in QoL associated with OSA and discuss the impact of OSA treatment with CPAP on the improvement of QoL.

Expert opinion: Because data regarding QoL assessments and whether QoL improves with CPAP in patients with no or less symptomatic OSA or mild OSA are scarce, clinical research in such patient populations is especially required. Moreover, it is widely accepted that a dose-response relationship exists between CPAP usage and a range of outcomes; therefore, to achieve the therapeutic effect of CPAP, improving CPAP adherence may be essential. The purpose of this review article was to discuss the relationship between OSA and impaired QoL and the possible mechanisms linking them.

Introduction: Modern-day cardiac pacing is no longer limited to the treatment of bradycardia but can be tailored to optimize cardiac hemodynamics through coordinated modulation of heart rate, atrioventricular (AV) coupling, and atrial and ventricular activation patterns as an integrated system. While traditional approaches have addressed these components in isolation, this review summarizes the mechanisms and clinical evidence of a 'whole-heart electro-mechanical optimization' approach for the treatment of bradycardia.

Areas covered: Accelerated atrial pacing can lower left-sided filling pressures and improve symptoms in patients with heart failure with preserved ejection fraction and diastolic dysfunction. Bachmann bundle-area pacing restores physiological atrial activation, which not only improves diastolic filling and reduces atrial arrhythmia burden but also redefines the effective AV delay. AV-sequential pacing enables optimization of AV-coupling to enhance left ventricular filling by restoring appropriate timing between early ventricular filling and atrial contraction, and by reducing diastolic mitral regurgitation. Importantly, conduction system pacing, typically left bundle branch area pacing, preserves near-normal ventricular activation enabling the full hemodynamic benefits of the preceding interventions without pacing-induced dyssynchrony.

Expert opinion: Together, these complementary and interdependent pacing strategies form an integrated 'whole-heart electro-mechanical optimization' approach aimed at integrative optimization of whole-heart pump function in selected patients.

Introduction: 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.

Areas covered: 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.

Expert opinion: 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.

Background: A new health monitoring device called Fitbit Charge 6 has appeared on the Vietnamese market. This study aimed to evaluate the consistency between Fitbit Charge 6 and structured interview questions in measuring sleep quality among breastfeeding mothers.

Research design and methods: A cross-sectional study utilizing random convenience sampling was conducted in Ho Chi Minh City, Vietnam, involving 208 breastfeeding women one month postpartum. The participants used the Fitbit Charge 6 device continuously for four days and three nights to gather daily sleep information; then, they were administered a structured sleep questionnaire via home interviews.

Results: The correlation between the total sleep time (TST) recorded by both the device and interview was weak (r = 0.28), as was the correlation for short nap duration (r = 0.25). The agreement between the Fitbit Sleep Score and sleep satisfaction from the questionnaire was 79.9%, with a notably low kappa coefficient (0.02), indicating a lack of strong agreement.

Conclusion: The Fitbit Charge 6 did not show reliable correlation with the subjective sleep data reported by one-month postpartum breastfeeding women. Further research employing rigorous comparative studies is necessary to assess the validity and reliability of sleep data collection methods for this demographic.

Introduction: Regenerative Peripheral Nerve Interface (RPNI) surgery represents a biologic solution to three major challenges in amputation care: (1) achieving intuitive, high-fidelity prosthetic control, (2) mitigating post-amputation pain, and (3) enabling meaningful sensory feedback. By using denervated autologous tissue as a physiologic target for regenerating axons, RPNI surgery is a promising strategy that permits closed-loop control of prosthetic devices.

Areas covered: This review focuses on unanswered questions and emerging opportunities regarding RPNI surgery. We examine three key areas: (1) determining the optimal number of RPNIs, (2) selecting the most appropriate graft tissue type, and (3) leveraging novel RPNI variations to expand clinical impact. To explore these topics, we synthesize preclinical and clinical evidence by systematically searching PubMed/MEDLINE, Embase, and Scopus for studies related to RPNI from inception to date. We aim to identify research priorities that will accelerate the evolution of RPNI surgery to revolutionize neuroprosthetic rehabilitation.

Expert opinion: RPNI surgery has evolved from proof-of-concept to a feasible, scalable strategy for treating patients with amputations. Future progress will depend on refining patient- and nerve-specific modifications, developing wireless, bidirectional devices that leverage RPNI signal transduction, and addressing reimbursement and training barriers. With continued interdisciplinary collaboration, RPNI surgery is poised to become a critical component of prosthetic rehabilitation.