Expert review of medical devices最新文献

Introduction: Conventional transtricuspid pacing including right ventricular pacing (RVP), cardiac resynchronization therapy (CRT), and implantable cardiac defibrillator (ICD) constitute the mainstay of device therapy for various indications relating to cardiac arrhythmia. However, devices with transtricuspid leads have been associated with tricuspid regurgitation (TR) progression which may exacerbate or lead to right ventricular dysfunction (RVD). Meanwhile, the impact of newer pacing modalities such as leadless pacing and conduction system pacing on TR progression and RVD is not well defined.

Areas covered: In this review article, we aim to summarize the risk and management of TR progression and RVD associated with different contemporary pacing modalities.

Expert opinion: We will provide practical recommendations for the pacing modality of choice in different settings to reduce the risk of TR progression and/or RVD. We will comment on the promising developments in cardiac pacing to reduce the risk of RVD and TR progression including leadless physiological pacing and right ventricular CRT.

Introduction: Medical devices are integral to the United States (US) healthcare sector, supporting the prevention, diagnosis, monitoring, and treatment of various medical conditions. Ranging from simple bandages to advanced diagnostic tools, these devices are key to delivering quality patient care. Among the critical parameters ensuring their safety and effectiveness is shelf-life, which defines the duration during which a device remains stable and functional as claimed on its label.

Areas covered: This article explores the significance of shelf-life in medical device development, highlighting the parameters that influence it. It also reviews instances of medical device recalls by the FDA that were attributed to shelf-life issues, analyzing their impact on patient safety. A narrative literature search was conducted using PubMed, Google Scholar, FDA.gov, EUR-Lex and IMDRF.org, covering materials published between January 2010 and April 2025.

Expert opinion: Shelf-life determination is a critical yet complex aspect of medical device development. While advancements in materials and manufacturing processes have improved device stability, unanticipated challenges can still arise, leading to recalls. Strengthening regulatory oversight, improving testing methodologies, and fostering proactive risk management strategies can significantly reduce the likelihood of shelf-life-related recalls, ensuring better patient outcomes.

Introduction: Pythium insidiosum keratitis (PIK) is a rapidly progressive, aggressive corneal infection that closely mimics fungal keratitis but fails to respond to conventional antifungal therapy. Misdiagnosis and delayed intervention frequently result in poor outcomes, including high rates of therapeutic keratoplasty and irreversible vision loss. Timely and accurate identification is therefore vital, yet conventional microbiological methods are slow, and histopathology is invasive and often inconclusive. Recent advances in imaging, molecular diagnostics, and biosensor technology are revolutionizing diagnostic possibilities.

Areas covered: Modern tools such as anterior segment optical coherence tomography (AS-OCT) and in vivo confocal microscopy(IVCM) permit rapid, noninvasive visualization of characteristic stromal patterns. Molecular platforms, including PCR, loop-mediated isothermal amplification (LAMP), recombinase polymerase amplification (RPA), and multiplex panels, provide precise results within hours. Innovative lateral flow immunoassays (LFIA), aptamer-based electrochemical biosensors, and artificial intelligence (AI)-assisted image interpretation expand point-of-care capabilities, while metagenomic sequencing aids in culture-negative cases.

Expert opinion: The integration of imaging, molecular, and biosensor modalities marks a paradigm shift in PIK diagnostics. PortableAS-OCT, handheld IVCM, and rapid multiplex panels promise to reduce diagnostic delay, minimize unnecessary antifungal use, lower keratoplasty rates, and improve visual prognosis. Collaborative validation and affordable access remain essential for global impact.

Background: This study evaluates clinical and economic outcomes among patients who received cementless, medial collared, triple-tapered hip stem (TTS) compared to other hip systems (non-TTS) for solely the posterior approach in THA.

Methods: This retrospective cohort study used US Medicare SAF data for THA patients from 1 January 2016 to 31 December 2023. Researchers compared outcomes from 11 surgeons performing posterior approach THA, selected based on expertise and identified via National Provider Identifier (NPI). The primary outcome was 3-month reoperation rate; exploratory outcomes included 2-year healthcare resource utilization and complication rates. Cohorts were balanced with propensity score fine stratification and analyzed using generalized linear models.

Results: There were 1,042 TTS and 1,483 non-TTS patients. The reoperation rate at 3 months was 2.3% for TTS and 2.8% for non-TTS. The 24-month dislocation rate was 2.3% for TTS and 4.6% for non-TTS, while the peri-prosthetic fracture rate was 2.1% for TTS and 1.1% for non-TTS. Twenty-four-month Medicare payments were similar for TTS ($29,310) and non-TTS ($28,542).

Conclusions: The reoperation rate was found to be non-inferior for the TTS compared to the non-TTS cohort for posterior THA. The results demonstrate that TTS is an effective option for the posterior approach in THA.

Introduction: Peripheral arterial intervention is a rapidly evolving field with a significant impact on an aging population.

Areas covered: Treatment concepts evolve rapidly, with new therapies providing sustainable and cost-effective solutions for complex patients.

Expert opinion: Metal stenting has been replaced by the 'leave-nothing-behind' approach, and plain balloon angioplasty devices have been replaced by drug-coated balloons (DCBs). While paclitaxel was initially used, sirolimus has more recently shown promising outcomes. This review article provides an overview of the technology and pharmacology behind sirolimus-coated balloons (SRL-DCB) and presents existing clinical evidence of their use.

Introduction: Cystoscopy is one of the most commonly performed invasive urological procedures, serving as a critical diagnostic and surveillance tool in urology, particularly for patients with bladder cancer and hematuria. Despite its routine use in outpatient settings, the procedure is frequently associated with significant patient-reported discomfort, which may adversely affect compliance with surveillance protocols and overall quality of care.

Areas covered: This review synthesizes evidence from 53 randomized controlled trials assessing interventions aimed at reducing discomfort during flexible cystoscopy. Strategies examined include intraurethral lidocaine, real-time visualization, music, hydrostatic irrigation, pharmacologic agents, devices, and behavioral approaches. The literature search encompassed studies published from January 2000 to September 2025 using PubMed and included a range of key terms related to cystoscopy and pain management.

Expert opinion: While no single intervention eliminates discomfort, several low-cost, easily implementable strategies, such as increased irrigation pressure, patient-selected music, and real-time visualization, demonstrate meaningful benefit. Pharmacologic interventions may be appropriate for select high-risk patients. Future efforts should prioritize multimodal, personalized approaches and real-world implementation research. Integrating patient-centered discomfort mitigation into routine cystoscopy workflows represents a tangible opportunity to improve procedural quality and adherence in urologic care.

Introduction: Ophthalmic implants including intraocular lenses, glaucoma drainage devices, corneal inlays, and keratoprosthesis are transformative in vision restoration. While randomized controlled trials (RCTs) establish pre-market safety and efficacy, they are limited in scope, duration, and generalizability. Post-market surveillance leveraging real-world evidence (RWE) has become indispensable to detect long-term complications, refine clinical practice, and support regulatory oversight.

Areas covered: This article reviews the evolution of post-market surveillance from spontaneous reporting systems to structured registries, mandated post-approval studies, and digital innovations. It highlights global regulatory frameworks such as FDA, EU MDR, and ISO, alongside international registries like IRIS®, EUREQUO, and MAUDE. The expanding role of artificial intelligence, tele-ophthalmology, and smart sensors in accelerating safety signal detection is emphasized. Ethical, legal, and privacy considerations, including GDPR and HIPAA compliance, are also discussed, with attention to disparities in low-resource settings.

Expert opinion: RWE is reshaping ophthalmic device surveillance by enabling early detection of rare adverse events, supporting value-based procurement, and guiding personalized implant selection. However, challenges remain in harmonizing regulatory pathways, ensuring patient privacy, and expanding infrastructure in resource-limited settings. Future priorities include fostering global data-sharing consortia, validating AI-driven analytics, and embedding continuous quality improvement to translate surveillance into safer, patient-centered care.

Introduction: Noninvasive brain monitoring and stimulation techniques are widely used in research and clinical applications. These techniques allow researchers and clinicians to study and affect brain activity safely, without any risk associated with invasive procedures.

Areas covered: The present review paper is focused on noninvasive brain monitoring and stimulation techniques. First, noninvasive brain monitoring techniques that are beneficial for clinical experts to detect neurological disorders are highlighted. These techniques also help to identify the exact locations where cognitive functions are disturbed. Second, noninvasive brain stimulation (NIBS) techniques that are provided to the patient's specific locations to improve the cognitive function by modulating the neuronal excitability are also discussed in this paper.

Expert opinion: Several clinical studies provide strong evidence related to the improvement of cognitive functions of patients suffering from neurological disorders using NIBS procedures. Various studies are being carried out to upgrade the noninvasive brain monitoring and stimulation techniques combined with artificial intelligence (AI) as transformative tool for advancing personalized portable home-based care, which may be beneficial to improve the lifestyle of patients suffering from the neurological disorders.

Background: Mechanically ventilated patients are at risk of respiratory complications, which may be reduced by proper oral care. The oral cleaning device (Swishkit, Swiftsure, Vancouver, Canada) was developed to facilitate cleansing, moisturization, and debris removal in intubated patients. We aimed to evaluate the feasibility and usability of this device in adult intensive care patients.

Methods: We conducted a prospective, single-center study at the Cleveland Clinic. Adult patients recovering from cardiac surgery and expected to remain intubated ≥2 hours were included. Feasibility was defined as successful completion of the procedure by nursing staff in addition to standard care. Usability was assessed with the Device Use Questionnaire (DUQ), scored on a 5-point scale (1 = easiest, 2.5 = neutral, 5 = difficult).

Results: Twenty-two patients were enrolled. The procedure was completed in 21/22 (95.5%). One attempt failed due to jaw clenching that prevented device placement, but this patient was included in the analysis. DUQ scores ranged from 1.3 to 2.3, reflecting easy to neutral usability. More than 85% of responses to usability questions were positive, and no residual saline was observed in the subglottic region.

Conclusion: Oral cavity cleansing with the oral cleaning device proved feasible and clinically usable in intubated patients recovering from cardiac surgery.

Trial registration: ClinicalTrials.gov Identifier: NCT05578599.