Expert review of medical devices最新文献

Introduction: Three-photon microscopy is an emerging tool for deep tissue imaging with superior spatial resolution. It enables imaging of portions of tissue beyond the typical depth limit of two-photon microscopy.

Areas covered: In this review, we give an overview of widely used deep tissue imaging modalities. We highlight the advantages of three-photon microscopy and review its current applications in biomedical research as well as its potential pre-clinical and clinical applications. Finally, we assess the challenges in the widespread use of three-photon live imaging in biomedical research and in clinical translation.

Expert opinion: Three-photon microscopy holds great promise as a biomedical research tool. It can uncover insights into the structure and function of tissues beyond what is accessible with two-photon microscopy. It also has promise to be a powerful clinical tool. Future clinical applications include optical biopsies with near instantaneous results and guided surgical resections. A multimodal strategy that combines three-photon technology with a large field of view, low resolution technique may be used to overcome the limited field of view of three-photon microscopy for macroscopic tissue assessment.

Introduction: Magnetic resonance imaging (MRI) provides superior soft tissue contrast, multiplanar capabilities, and avoids ionizing radiation, making it valuable for evaluating orthopedic conditions. Despite persistent concerns regarding MRI safety with orthopedic instrumentation, this imaging modality is particularly well-suited to evaluate pain and weakness following hardware placement. This review examines the evidence regarding safety and efficacy of MRI in patients with orthopedic implants.

Areas covered: This review covers potential safety risks including device displacement and thermal energy deposition during MRI examinations, artifact reduction techniques such as multispectral imaging, and clinical applications in diagnosing complications surrounding orthopedic hardware. Evidence demonstrates MRI's utility in detecting adverse local tissue reactions, periprosthetic infections, implant loosening, and soft tissue complications following joint arthroplasty.

Expert opinion: Based on extensive clinical experience with thousands of patients, MRI is both safe and diagnostically valuable for monitoring patients with orthopedic hardware. Modern orthopedic implants almost exclusively use non-ferromagnetic materials, eliminating displacement risks. While RF-induced heating requires consideration, no confirmed reports exist of tissue damage from MRI-induced thermal deposition near orthopedic devices. MRI serves as a particularly valuable screening tool for identifying early-stage soft tissue reactions and osteolysis, especially critical in scenarios where proactive monitoring can significantly improve outcomes.

Background: In 2022, a report by the World Health Organization revealed 2.3 million new breast cancer cases and 670,000 related deaths, which represented 11.7% of all cancer cases worldwide. Early screening and biopsy for breast cancer can provide more effective and minimally invasive treatment options. As treatment options evolve, breast cancer surgery can ensure cure rate and aesthetics after surgery.

Areas covered: This review article examines the latest advancements in breast cancer care, highlighting the integration of artificial intelligence (AI) in diagnostics, the development of haptic-based breast biopsy simulators, and innovative surgical techniques.

Expert opinion: AI-driven diagnostic systems have significantly improved the accuracy and effectiveness of breast cancer screening with a precision comparable to that of experienced radiologists. Furthermore, haptic-based breast biopsy simulators are revolutionizing surgical training by providing practitioners with a realistic and safe environment to refine their biopsy techniques and breast surgery skills. Concurrently, advancements in surgical procedures, often augmented by AI and virtual reality (VR) simulations, are transforming breast cancer treatment, which facilitate the practice of complex surgical techniques, potentially resulting in more specialized and minimally invasive procedures. Collectively, these innovations are improving the screening, diagnosis, and surgical results for breast cancer patients.

Introduction: Glioblastoma (GBM) stands as one of the most challenging malignancies to treat, with a prognosis that remains notably poor despite advancements in therapeutic strategies.

Areas covered: TTFields therapy is a novel approach to targeting cancer cell proliferation through alternating electric fields. The mechanism of action, dielectrophoresis, selectively disrupts mitotic processes in replicating cells, offering a localized treatment option with minimal systemic side effects.Clinical trials have demonstrated promising results, with TTFields therapy significantly improving progression-free and overall survival rates when combined with standard adjuvant treatments. However, questions regarding its impact on neuropsychological functioning and management of postoperative motor deficits remain unanswered.

Expert opinion: In conclusion, while TTFields therapy presents a valuable addition to GBM treatment modalities, further research is warranted to elucidate its full potential and address remaining challenges.

Introduction: Thromboembolic conditions are a leading global cause of mortality and a major cause of disability. Throughout the years mechanical thrombectomy has become a preferred method of treatment. Removing thrombus in its entirety on first pass decreases procedure time as well as lowers the risk of distal embolization.

Areas covered: This review provides a comprehensive overview and classification of the patent literature on devices for non-fragmented thrombus removal via grip. Patentscope database was used to search for internationally granted patents published any time before the access date (October 2024). The search using keywords and patent classification code led to identifying 141 relevant patents that were then categorized based on location and type of grip they describe.

Expert opinion: The designs found are analyzed in the discussion and a broader context for their relevance is given in the expert opinion section. The following review can provide insight into possible mechanical thrombectomy methods, general trends in the field as well as serve as an inspiration in development of novel devices.

Introduction: The advent of refractive cataract surgery has resulted in better spectacle independence and quality of life in patients, accompanied by increased patient expectations. Photic phenomena, such as glare, halo, and starbursts, are the most common visual complaints in patients and have become major causes of dissatisfaction after refractive cataract surgery.

Areas covered: Our review aimed to explore the incidence, risk factors, prevention, and management strategies for photic phenomena after presbyopia-correcting intraocular lens implantation, providing evidence to develop strategies to prevent and treat photic phenomena. The following databases were searched PubMed, Embase, and Web of Science to conduct the review. The level of scientific evidence was graded according to the Scottish Intercollegiate Guidelines Network (SIGN).

Expert opinion: Photic phenomena remain a significant challenge in refractive cataract surgery, despite advancements in presbyopia-correcting intraocular lens technology. Based on current evidence, rigorous patient selection, precise surgical execution, and tailored postoperative care - is paramount to minimizing photic phenomena. Surgeons must balance technological innovation with individualized patient counseling to align expectations with achievable visual outcomes. Future well-designed studies and advanced simulation tools are needed to better assess these symptoms, explore related risk factors, and improve prevention strategies.

Introduction: Targeted temperature management (TTM) is a well-established neuroprotective intervention for patients following cardiac arrest (CA), ischemic stroke, traumatic brain injury, and related conditions.

Areas covered: With the continued development of cooling technology, there is an increasing variety of TTM devices and cooling methods. Related application scenarios have also expanded to pre-hospital and in-hospital Settings. This paper provides a systematic review of existing TTM devices and strategies, offering a comprehensive comparative analysis of various TTM methodologies employed in cardiopulmonary resuscitation (CPR) on the basis of their underlying cooling mechanisms.

Expert opinion: The paper further explores current developmental trends and ongoing controversies surrounding the implementation of TTM. TTM devices are advancing toward selective, minimally invasive, and intelligent designs. With the increasing portability and miniaturization of these devices, TTM strategies are transitioning toward phased and integrated approaches.

Introduction: Integration of clinical trials into FDA approval processes is essential for ensuring the safety and efficacy of neuromodulation devices.

Methods: From 1960 to 2023, 125 FDA-approved neuromodulation records corresponding to 109 publications (64 randomized, 45 nonrandomized trials) were identified. Regulatory records and published trial characteristics were reviewed.

Results: Safety outcomes were reported in 95.4% of randomized and 82.2% of nonrandomized trials, with serious adverse events in ~ 75% of the studies. Efficacy analyses showed small Cohen's d effect sizes in 65.85% of outcomes, medium in 24.39%, and large in 9.76%, with a median NNT of 4.65. Industry funded 87.5% of randomized trials, and conflicts of interest were disclosed in 92.2% of publications. Approximately, 20% of devices were recalled - exclusively invasive. Randomized trials had larger sample sizes (median 152 subjects) than nonrandomized studies (median 53; p < 0.001), and study duration varied significantly by indication (p < 0.001).

Conclusions: Our findings reveal considerable heterogeneity in the evidence supporting neuromodulation devices, with trials showing systematic safety documentation but modest efficacy. Industry-funded trials dominate the evidence base, with recalls primarily limited to invasive technologies. Evidence gaps persist in minority representation and longitudinal data.

Introduction: Non-invasive brain stimulations (NIBS), such as transcranial magnetic stimulation, transcranial direct current stimulation, transcranial alternating current stimulation, transcranial focused ultrasound, and transcranial pulse stimulation (TPS), employ electric currents or acoustic waves to induce and modulate neuroplasticity in humans. Thus, NIBS have the capacity to modify pathological plasticity while promoting plasticity in neuropsychiatric disorders, helping to ameliorate symptoms and enhance rehabilitation.

Areas covered: The efficacy of TPS in treating neuropsychiatric disorders is still unknown; hence, this article reviews the currently available clinical studies on the therapeutic effectiveness of TPS on symptom reduction in the clinical population to inform future neuropsychiatric treatments and research directions.

Expert opinion: The emerging NIBS treatment modality TPS demonstrates promising evidence in modulating symptoms in clinical population of neurocognitive disorders, common mental disorders, and neurodevelopmental disorders. It has been well tolerated across age groups, from adolescents to older adults. Thus, it is essential to encourage future research to investigate the underlying neurophysiological and biochemical effects of TPS, as well as its sustainability, by incorporating high-quality randomized controlled trials with larger sample sizes to strengthen the validation of its effects.