Expert review of medical devices最新文献

Introduction: The integration of software into medical devices has profoundly transformed the healthcare landscape, enabling precise diagnostics, personalized treatment , and remote patient monitoring. The rapid pace of software development - especially with artificial intelligence (AI) and machine learning (ML) - demands regulatory frameworks to ensure patient safety, effectiveness, and reliability.

Areas covered: Software as a Medical Device (SaMD) refers to software intended for medical purposes that operates independently of a physical device. This article traces the historical development of regulatory approaches, deconstructs existing frameworks, analyzes challenges and influencing factors, presents case studies, and anticipates future trends. A narrative literature search was conducted using PubMed, Google Scholar, FDA.gov, EUR-Lex and IMDRF.org, covering materials published between January 2013 and May 2025.

Expert opinion: The Total Product Lifecycle (TPLC) framework is essential for managing evolving risks and performance of AI/ML-based SaMD. These technologies are redefining regulatory assumptions, requiring systems that ensure transparency, mitigate bias, sustain trust, and promote equitable, safe innovation.

Introduction: Severe mitral regurgitation (MR) poses significant therapeutic challenges, especially in patients at high surgical risk or unsuitable for transcatheter edge-to-edge repair (TEER). Transcatheter mitral valve replacement (TMVR) has emerged as a viable alternative, with the EVOQUE Eos system representing a next-generation, fully retrievable, transseptal TMVR platform tailored to address prior limitations in safety, anatomical fit, and procedural control.

Areas covered: This review outlines the design features, procedural considerations, and early clinical performance of the EVOQUE Eos TMVR system, referencing results from the first-in-human experience and the ongoing MISCEND trial. Furthermore, the EVOQUE Eos is compared with other contemporary TMVR systems. Procedural challenges such as paravalvular leak, left ventricular outflow tract (LVOT) obstruction, bleeding, and hypoattenuated leaflet thickening (HALT) are discussed in context.

Expert opinion: The EVOQUE Eos system marks a pivotal advancement in TMVR by offering fully percutaneous access, intuitive deployment, and retrievability. While early outcomes are encouraging, further data are needed to guide patient selection, antithrombotic management, and long-term valve durability. The system may play a central role in the expanding treatment landscape for MR, potentially transforming standard practice in the coming years.

Introduction: Focused transcranial ultrasound stimulation (fTUS) has emerged as a novel noninvasive technique with promising therapeutic potential for various neurological and psychiatric conditions. The aim of this review is to evaluate current research on fTUS, examining its mechanisms, therapeutic applications, challenges, and future potential in neurological and psychiatric disorders.

Area covered: High-intensity fTUS leads to heat-induced thermoablation, which has shown efficacy in treating essential tremor and tremor-dominant Parkinson's disease, with promising outcomes in clinical trials. fTUS has been explored for blood-brain barrier opening, facilitating drug delivery for conditions like glioblastoma and Alzheimer's disease. Low-intensity fTUS can also be used as a novel neuromodulation tool which has shown potential in alleviating chronic pain, depression, and cognitive decline.

Expert opinion: Challenges remain, including technical refinements, standardization of parameters, and optimization of therapeutic protocols. Emerging approaches like hyperthermia therapy, sonodynamic therapy, and sonothrombolysis hold promise for future applications. With ongoing research and collaboration, the next decade holds immense potential for further advancements in fTUS technology and its clinical integration.

Introduction: Gait impairments due to neurologic injury or disease significantly compromise mobility and quality of life. Traditional gait rehabilitation approaches, though grounded in motor learning principles, often face limitations in delivering sufficient intensity, specificity, and ecological validity.

Areas covered: This review considers the landscape of wearable technologies for gait rehabilitation, including robotic exoskeletons, neuromodulation, and sensory augmentation platforms such as virtual/augmented reality (VR/AR) and biofeedback. Literature was identified through comprehensive searches of clinical studies, systematic reviews, and feasibility trials. The paper explores mechanisms, clinical applications, and evidence supporting their use in gait rehabilitation for neurological populations.

Expert opinion: Wearable technologies will continue to transform neurorehabilitation by enabling more precise, consistent, and personalized therapy both in the clinic and at home. However, adoption can be limited by high costs, usability challenges, fragmented evidence, and limited integration into clinical workflows. Realizing their full potential will require strong interdisciplinary collaboration and structured training pathways to support clinical use. Continued advances in hardware and software, including AI integration, will further enhance their impact by enabling more adaptive and efficient care. In five years, we anticipate a major integration of wearable systems as part of data-driven rehabilitation ecosystems, improving access and long-term recovery outcomes.

Introduction: Diagnosis and treatment of lymphedema revolve around microsurgical and supermicrosurgical techniques, and various imaging modalities are integral to these techniques. Here, we discuss both the historic and novel imaging modalities in the diagnosis, pre-operative management, intra-operative period, and post-operative analysis of lymphedema.

Areas covered: Lymphoscintigraphy has been the gold-standard for diagnosis of lymphedema, although with poor image resolution, it has fallen out of favor. Indocyanine green lymphography is a versatile imaging technique that is both portable and user-friendly. It can be used both for pre-operative planning and intra-operative confirmation of anastomotic patency. Magnetic resonance lymphography, while more expensive and technically challenging, provides information on lymphatics as well as surrounding vasculature and soft tissue characteristics. Ultra-high frequency ultrasound is an adjunctive technology that is helpful in both the pre-operative and intra-operative setting for selection of anastomotic targets. Novel techniques such as contrast-enhanced ultrasound and photoacoustic imaging have promising applications to lymphatic surgery.

Expert opinion: Imaging in lymphatic surgery continues to evolve, with novel technologies providing promise in advancing the field. Advances continue to improve access to imaging both in the clinic and operating room, helping to improve surgical techniques and success of lymphatic surgeries.

Background: Scientific evidence on novel transarticular inferior-posterior surgical approaches for sacroiliac (SI) joint fusion, designed to minimize the risk of neurovascular injury, remains limited.

Methods: This prospective, multi-center study evaluated disability (ODI), SI-joint pain (VAS), and patient satisfaction following SI joint fusion using the inferior-posterior approach. The primary endpoint was composite success, defined as: (1) ≥20 mm VAS pain reduction, (2) no device-related serious adverse events, (3) no neurological worsening, and (4) no surgical reintervention. Fusion was assessed at 12 months via independent radiographic CT review.

Results: Thirty-six patients (mean age: 58.9 years; 77.8% female) underwent treatment. At the time of analysis, ODI significantly improved from 51.6% at baseline to 28.0% at 6-month (n = 32) and 20.8% at 12-month (n = 24, all p < 0.001). VAS scores declined from 78.8 mm to 35.6 mm at 6-month (n = 30) and 23.0 mm at 12-month (n = 24, all p < 0.001). Composite success was achieved in 73.3% at 6 month and 87.0% at 12 months (post hoc). Fusion was confirmed in 82.6% of cases, with 83.3% patient satisfaction. No serious device- or procedure-related adverse events or reinterventions were reported.

Conclusion: This interim analysis of an ongoing study demonstrates significant improvements in disability and pain, while the novel surgical approach promotes fusion. Although the results are promising, larger studies with longer follow-up are warranted to validate these findings.

Introduction: Dry eye disease (DED) affects over 300 million people worldwide and continues to pose diagnostic challenges due to fluctuating symptoms and reliance on static, clinic-based tests. Conventional methods such as Schirmer's test and tear osmolarity provide only episodic insights, failing to capture the dynamic behavior of the tear film. Recently, biosensor-embedded wearable devices, including smart contact lenses, eyelid-mounted patches, and sensor-equipped spectacles, have emerged, enabling real-time and continuous tracking of tear metrics and blink patterns. These technologies promise precision diagnostics and patient-specific therapeutic strategies.

Areas covered: This review summarizes recent advances in ocular biosensor wearables for DED. Key innovations include smart lenses with osmolarity and biomarker sensors, microfluidic channels for tear collection, and eyelid-mounted iontronic sensors for blink monitoring. Regulatory pathways such as FDA 510(k), ISO 10,993 safety standards, and HL7 FHIR for data integration are discussed. Early clinical studies support feasibility, though power supply, device miniaturization, and patient adherence remain obstacles. Ethical, economic, and privacy considerations are also highlighted.

Expert opinion: Biosensor-based wearables are redefining DED care, offering precision diagnostics, early intervention, and long-term monitoring. Their success depends on clinical validation, affordability, patient comfort, and seamless integration with telehealth. Interdisciplinary collaboration will be crucial to transition these innovations into routine clinical practice.

Introduction: Benign Prostatic Hyperplasia (BPH) can lead to Lower Urinary Tract Symptoms (LUTS) that worsen with age and impact quality of life. Minimally invasive Surgical Therapies (MISTs) provide an alternative to medical and surgical interventions for the treatment of LUTS. The Optilume BPH Catheter System is a MIST for LUTS, which is the focus of this review.

Areas covered: The Optilume BPH Catheter System is a Food and Drug Administration (FDA)-approved MIST that utilizes balloon dilation and delivery of paclitaxel to the prostatic urethra to treat LUTS. This review evaluates the technology, utility, clinical evidence, safety profile, and long-term efficacy of Optilume BPH Catheter System, in the context of alternative options for management of LUTS. PubMed and Google Scholar were searched and all published articles and abstracts up to May 2025 related to Optilume BPH Catheter Systems were included in our review.

Expert opinion: The Optilume BPH Catheter System is a promising MIST in the market with durable results and acceptable safety profile. Ongoing and future research will further refine its long-term safety and efficacy.