Expert review of medical devices最新文献

Introduction: The Respimat Soft Mist Inhaler (SMI), introduced in the early 2000s, represented a significant, represented a significant advancement in inhaled drug delivery for chronic obstructive pulmonary disease (COPD). It offers improved lung deposition, lower oropharyngeal impaction, and enhanced ease of use compared to traditional pressurized or dry powder inhalers.

Area covered: This review provides an up-to-date overview of the Respimat SMI's design, inhaler performance, aerosol and lung deposition characteristics, clinical efficacy, patient-reported outcomes, and environmental impact. Comparative data with pressurized metered-dose inhalers (pMDIs), dry powder inhalers (DPIs), and emerging generic alternatives (e.g. MRX004) are critically discussed. The review also addresses usability, patient preference, and the increasing shift toward reusable, propellant-free inhalation platforms.

Expert opinion: Respimat provides an effective, user-friendly alternative to conventional inhalers, especially for patients with suboptimal inspiratory flow or poor coordination Its fine-particle aerosol, high peripheral deposition, and environmentally sustainable design align with evolving clinical, economic, and policy priorities. Although further real-world data are needed, particularly regarding long-term adherence and device mastery, Respimat sets a benchmark for future inhaler innovation in terms of therapeutic performance, sustainability, and patient-centered care.

Background: Evidence for LithoVue™ Elite Single-Use Digital Flexible Ureteroscope (LVE) with pressure monitoring vs. other single-use ureteroscopes is needed.

Research design and methods: This study using US electronic health records evaluated patients undergoing ureteroscopy (URS) with laser lithotripsy between 1 January 2023 and 1 June 2025. The primary endpoint was post-operative infection, defined as urinary tract infection (UTI), sepsis, and other infections, assessed at 10- and 30-days post-index procedure. Propensity score matching controlled for baseline differences.

Results: After matching, 208 patients with LVE with pressure monitoring (mean age 61.4; 48.1% female; 79.3% White) and 416 with other single-use ureteroscopes without pressure monitoring (mean age 61.8; 48.1% female; 78.1% White) were evaluated. Post-operative LVE with pressure monitoring infection was significantly lower at 30 days post-index (8.2% vs. 15.4%; p = 0.016). Multivariable analyses confirmed significantly higher odds of 30-day infection with other single-use ureteroscopes (odds ratio 2.09 [95% confidence interval 1.19-3.86]; p = 0.014). Post-operative sepsis and other infections did not statistically differ; however, post-operative 30-day UTI was significantly less with LVE with pressure monitoring (5.2% vs. 10.8%; p = 0.033).

Conclusions: LVE with pressure monitoring was associated with reduced 30-day post-URS infection. These findings support clinical improvement with LVE and suggest that intrarenal pressure monitoring may contribute to better short-term outcomes.

Background: Tracheal intubation can be challenging, especially in unanticipated cases, where patient positioning plays a critical role. The bed-up-head-elevated (BUHE) position may improve intubation outcomes.

Research design and methods: This randomized non-inferiority trial included 90 ASA I-II patients undergoing elective surgery. Patients were randomly allocated into two groups. Group 1 underwent Macintosh laryngoscopy in the BUHE position followed by C-MAC laryngoscopy in the supine position, while Group 2 followed the reverse order. Endotracheal intubation was attempted with the second blade used for laryngoscopy. Laryngeal exposure was evaluated using Percentage of Glottic Opening (POGO) scores and Cormack - Lehane (CL) grading with a non-inferiority margin of -15% for POGO scores. Secondary outcomes included time required for intubation, attempts, adjuncts, effort, and complications.

Results: BUHE Macintosh laryngoscopy yielded a mean POGO score of 50.5% compared to 63.4% with supine C-MAC laryngoscopy, with a mean difference of -12.9% (95% CI: -16.6% to -9.3%). CL grading favored C-MAC, while secondary outcomes showed no significant differences.

Conclusion: BUHE Macintosh laryngoscopy resulted in lower laryngeal exposure, as the confidence interval crossed the non-inferiority margin. However, secondary outcomes remained comparable. Further studies are required to validate these findings and refine non-inferiority margins.

Trial registration-: CTRI/2023/02/050036.

Background: Blood sampling is essential for infectious disease diagnosis and monitoring but often requires venipuncture, limiting accessibility. Self-sampling offers a decentralized alternative, yet current macro-blood sampling methods are scarce. The device was developed to enable standardized, user-friendly self-sampling of ≥ 500 µL capillary fingerprick blood.

Research design and methods: Via an iterative, mixed-method approach, we optimized the Collect2Know device (C2K) across five prototypes (P1-P5). Usability, acceptability, and blood volume of each prototype were assessed among minimum 10 participants. A minimum threshold of 75% usability and acceptability, and 60% of users collecting minimum 500 µL guided device refinement.

Results: The first prototype (P1) underperformed, leading to redesign. P2-P3 improved usability and acceptability but failed volume collection targets. P4 incorporated substantial improvements, making the prototype more intuitive, and 77.5% (31/40) achieved success in blood collection with usability and acceptability scores of 89.1% and 75.6%, respectively.

Conclusions: This study highlights the value of an iterative study-design, in the early stages of device development. The C2K device will facilitate capillary fingerprick macro-bloodsampling. By shifting routine blood sampling to decentralized settings, the C2K device may have the potential to enhance access to diagnostics, reduce healthcare burdens, and support public health efforts in both high- and low-resource settings.

Introduction: Many legal and regulatory requirements need to be considered in projects developing medical AI systems. Their implementation may be challenging as both AI technology and some of the regulations are new.

Areas covered: This article examines the key legal challenges arising from the EU General Data Protection Regulation, Medical Devices Regulations, AI Act, as well as selected intellectual property issues in multi-partner projects developing medical AI systems, using an ongoing clinical validation study of such a device as a real-world exemplar.

Expert opinion: The current regulatory landscape for medical AI system validation in Europe is complex, evolving, and presents some conflicting principles. Key areas that need to be addressed in future soft law instruments include data anonymization and interplay between the Medical Devices Regulation, AI Act, and General Data Protection Regulation. Policymakers should invest in regulatory science to ensure that regulatory frameworks are evidence-based and prioritize patient safety while fostering innovation.

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.