Expert review of medical devices最新文献

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.

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.