Expert review of medical devices最新文献_第4页

Functional electrical stimulation as a tool to restore motor control after spinal cord injury: translation to clinical practice. 功能性电刺激作为恢复脊髓损伤后运动控制的工具：转化为临床实践。

Expert review of medical devices Pub Date : 2025-06-10 DOI: 10.1080/17434440.2025.2517169

Kristin E Musselman, Hope Jervis-Rademeyer, Elina Nezon

{"title":"Functional electrical stimulation as a tool to restore motor control after spinal cord injury: translation to clinical practice.","authors":"Kristin E Musselman, Hope Jervis-Rademeyer, Elina Nezon","doi":"10.1080/17434440.2025.2517169","DOIUrl":"10.1080/17434440.2025.2517169","url":null,"abstract":"Introduction: Functional electrical stimulation (FES) is a therapeutic tool that may augment motor recovery after spinal cord injury/disease (SCI). It involves applying an electrical current to muscles and/or peripheral nerves to facilitate functional movements, such as walking and reaching. Despite the potential therapeutic benefits of FES, and the considerable investment into its research and development, FES is not widely used in clinical practice.Areas covered: In this narrative review, we examine this research-to-practice gap. PubMed and Google Scholar were searched using keywords related to the population, constructs and context of interest. We provide an orientation to SCI and summarize how FES may facilitate motor recovery. Using the Knowledge-to-Action Framework as a guide, we demonstrate how co-design and implementation strategies can be incorporated into FES device development and research to aid clinical translation in SCI rehabilitation. Based on prior literature, we provide recommendations for researchers and technology developers: 1) collaborate with implementation scientists, 2) adopt participatory methods, 3) use a knowledge translation framework as a guide, 4) thoroughly understand implementation barriers and facilitators, and 5) budget time for implementation.Expert opinion: Greater focus on clinical implementation is needed in the FES research field to address the current research-to-practice gap.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-12"},"PeriodicalIF":0.0,"publicationDate":"2025-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144228056","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Revolutionizing breast cancer care: the synergy of AI-powered diagnostics, haptic-based biopsy simulators, and advanced surgical techniques. 革新乳腺癌护理：人工智能诊断、基于触觉的活检模拟器和先进手术技术的协同作用。

Expert review of medical devices Pub Date : 2025-06-09 DOI: 10.1080/17434440.2025.2514007

Tanyaradzwa Roselyn Tichiwangana, Qianwen Ji, Xingqi Fan, Tao Ying, Xiaojun Chen

{"title":"Revolutionizing breast cancer care: the synergy of AI-powered diagnostics, haptic-based biopsy simulators, and advanced surgical techniques.","authors":"Tanyaradzwa Roselyn Tichiwangana, Qianwen Ji, Xingqi Fan, Tao Ying, Xiaojun Chen","doi":"10.1080/17434440.2025.2514007","DOIUrl":"10.1080/17434440.2025.2514007","url":null,"abstract":"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.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-17"},"PeriodicalIF":0.0,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144182383","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Deep learning without borders: recent advances in ultrasound image classification for liver diseases diagnosis. 无边界深度学习：肝脏疾病超声图像分类的最新进展。

Expert review of medical devices Pub Date : 2025-06-09 DOI: 10.1080/17434440.2025.2514764

Midya Yousefzamani, Farshid Babapour Mofrad

{"title":"Deep learning without borders: recent advances in ultrasound image classification for liver diseases diagnosis.","authors":"Midya Yousefzamani, Farshid Babapour Mofrad","doi":"10.1080/17434440.2025.2514764","DOIUrl":"10.1080/17434440.2025.2514764","url":null,"abstract":"Introduction: Liver diseases are among the top global health burdens. Recently, there has been an increasing significance of diagnostics without discomfort to the patient; among them, ultrasound is the most used. Deep learning, in particular convolutional neural networks, has revolutionized the classification of liver diseases by automatically performing some specific analyses of difficult images.Areas covered: This review summarizes the progress that has been made in deep learning techniques for the classification of liver diseases using ultrasound imaging. It evaluates various models from CNNs to their hybrid versions, such as CNN-Transformer, for detecting fatty liver, fibrosis, and liver cancer, among others. Several challenges in the generalization of data and models across a different clinical environment are also discussed.Expert opinion: Deep learning has great prospects for automatic diagnosis of liver diseases. Most of the models have performed with high accuracy in different clinical studies. Despite this promise, challenges relating to generalization have remained. Future hardware developments and access to quality clinical data continue to further improve the performance of these models and ensure their vital role in the diagnosis of liver diseases.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-17"},"PeriodicalIF":0.0,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144188667","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Diagnostic value of 24-hour Holter monitoring and conventional electrocardiogram in arrhythmia. 24小时动态心电图与常规心电图对心律失常的诊断价值。

Expert review of medical devices Pub Date : 2025-06-04 DOI: 10.1080/17434440.2025.2514008

Juan Liu, Yang Li, Yuzhan Wang

{"title":"Diagnostic value of 24-hour Holter monitoring and conventional electrocardiogram in arrhythmia.","authors":"Juan Liu, Yang Li, Yuzhan Wang","doi":"10.1080/17434440.2025.2514008","DOIUrl":"10.1080/17434440.2025.2514008","url":null,"abstract":"Objective: This paper aims to compare the diagnostic value of 24-hour Holter monitoring and conventional electrocardiogram (ECG) in arrhythmia.Methods: The diagnostic results of 24-hour Holter monitoring and conventional ECG for these patients were compared. The diagnostic efficacy, including sensitivity, specificity, and accuracy, of the two types of ECGs was compared. Additionally, the detection rates of ventricular premature contractions in bigeminy and trigeminy, paired ventricular premature contractions, atrial premature contractions in bigeminy and trigeminy, paired atrial premature contractions, and atrioventricular conduction block by both methods were compared. Patient satisfaction with the diagnostic results of two methods was also compared.Results: Compared to the conventional ECG, 24-hour Holter monitoring exhibited higher sensitivity, specificity, and accuracy; higher detection rates of ventricular premature contractions in bigeminy and trigeminy, paired ventricular premature contractions, atrial premature contractions in bigeminy and trigeminy, paired atrial premature contractions, and atrioventricular conduction block; higher patient satisfaction.Conclusion: The 24-hour Holter monitoring demonstrates superior sensitivity, specificity, accuracy, and detection rate in diagnosing arrhythmia compared to conventional ECG. Additionally, it offers higher patient satisfaction, making it more valuable for clinical application.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-5"},"PeriodicalIF":0.0,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144176239","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Consumer-facing and professional medical devices in cardiology: monitoring and evaluation of big data and the implications for the practice of cardiology. 心脏病学中面向消费者和专业的医疗设备：大数据的监测和评估及其对心脏病学实践的影响。

Expert review of medical devices Pub Date : 2025-06-03 DOI: 10.1080/17434440.2025.2514005

Sri Nuvvula, Amgad N Makaryus

{"title":"Consumer-facing and professional medical devices in cardiology: monitoring and evaluation of big data and the implications for the practice of cardiology.","authors":"Sri Nuvvula, Amgad N Makaryus","doi":"10.1080/17434440.2025.2514005","DOIUrl":"10.1080/17434440.2025.2514005","url":null,"abstract":"Introduction: With the ever-expanding increase in the availability of electronic devices that can monitor everything from a patient's daily step count to more detailed devices that can measure or estimate pulmonary artery pressures in patients with heart failure, the amount of data measured by these devices produces mountains of information.Areas covered: Our review will examine the various options and developments of both consumer-facing and professional medical devices. We discuss provider-facing cardiac devices including pacemakers, implantable cardioverter-defibrillators, Holter monitors, implantable loop recorders, left ventricular assist devices, patch monitors, and pulmonary artery pressure sensors, as well as consumer-facing cardiac medical devices including the Apple Watch and the Fitbit wearable device. We searched through the available studies on the PubMed, Cochrane Library, and Embase databases for information on these devices. The role of artificial intelligence in the analysis and interpretation of data currently and in the future is also discussed.Expert opinion: We expect future consumer-facing cardiac medical devices to focus on ventricular arrhythmias especially given their clinical impact. We also expect clinical data and patient-specific information to play a larger role as artificial intelligence advances, and it becomes more capable of drawing conclusions using multiple variables from a single patient.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-12"},"PeriodicalIF":0.0,"publicationDate":"2025-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144183092","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The device-aided intrajejunal delivery of levodopa-entacapone-carbidopa intestinal gel the treatment of Parkinson's disease: overview of efficacy and safety. 器械辅助空肠内给药左旋多巴-恩他卡彭-卡比多巴肠凝胶治疗帕金森病的疗效和安全性综述

Expert review of medical devices Pub Date : 2025-06-01 Epub Date: 2025-05-08 DOI: 10.1080/17434440.2025.2499153

Karolina Popławska-Domaszewicz, Vinod Metta, Per Odin, K Ray Chaudhuri

{"title":"The device-aided intrajejunal delivery of levodopa-entacapone-carbidopa intestinal gel the treatment of Parkinson's disease: overview of efficacy and safety.","authors":"Karolina Popławska-Domaszewicz, Vinod Metta, Per Odin, K Ray Chaudhuri","doi":"10.1080/17434440.2025.2499153","DOIUrl":"10.1080/17434440.2025.2499153","url":null,"abstract":"Introduction: Device-aided therapies (DATs) have been developed to provide continuous drug delivery (CDD) to people with advanced Parkinson's disease (PD) whose symptoms can no longer be effectively managed with oral or transdermal therapy. Intrajejunal infusion of levodopa-carbidopa intestinal gel (LCIG), delivered via the CADD Legacy 1400 pump, is an established CDD option, while levodopa-entacapone-carbidopa intestinal gel (LECIG), delivered via the Crono LECIG pump, is a more recent addition to the range of DAT options in Europe.Areas covered: This article explores the rationale for the development of LECIG infusion, the role of entacapone in the formulation, and the attributes and specifications of the LECIG infusion pump device. Clinical and real-world data reporting its efficacy, safety and tolerability of LECIG in advanced PD patients from a range of European centers are reviewed, with a focus on the practical benefits that a smaller, lighter and quieter device can provide for patients who wish to start treatment with intrajejunal levodopa infusion.Expert opinion: LECIG infusion delivered via the LECIG infusion pump offers another valuable DAT option to consider for suitable people with advanced PD providing both good long-term clinical benefits and a favorable treatment experience for patients.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"533-544"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144015140","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Comparison of various video laryngoscopes for nasotracheal intubation in simulated difficult airway scenarios: a randomized self-controlled crossover trial. 不同视频喉镜在模拟气道困难情况下进行鼻气管插管的比较：一项随机自我对照交叉试验。

Expert review of medical devices Pub Date : 2025-06-01 Epub Date: 2025-05-04 DOI: 10.1080/17434440.2025.2499150

Prateek Maurya, Anju Gupta, Nishkarsh Gupta, K Smita Reddy, Vinod Kumar, Sachidanand Jee Bharati, Rakesh Garg, Seema Mishra, Sushma Bhatnagar, Gyaninder Pal Singh, Arindam Choudhury, Rajeev Kumar Malhotra

{"title":"Comparison of various video laryngoscopes for nasotracheal intubation in simulated difficult airway scenarios: a randomized self-controlled crossover trial.","authors":"Prateek Maurya, Anju Gupta, Nishkarsh Gupta, K Smita Reddy, Vinod Kumar, Sachidanand Jee Bharati, Rakesh Garg, Seema Mishra, Sushma Bhatnagar, Gyaninder Pal Singh, Arindam Choudhury, Rajeev Kumar Malhotra","doi":"10.1080/17434440.2025.2499150","DOIUrl":"10.1080/17434440.2025.2499150","url":null,"abstract":"Background: Nasotracheal intubation (NTI) is particularly challenging in patients with rigid neck or micrognathia. Advancements in video laryngoscopy may improve NTI outcomes. We compared performance of direct laryngoscope (DL), King Vision videolaryngoscope (KVL), and C-MAC videolaryngoscope (VL) in normal, rigid neck, and micrognathia airway.Methods: A randomized, self-controlled crossover trial was conducted with 20 anesthesiologists who performed NTI on a high-fidelity mannequin under three airway conditions. Device order was randomized using a computer-generated sequence, and outcome assessors were blinded to the sequence of devices used. Primary outcomes were time to glottic view and intubation. Secondary outcomes included ease of intubation and force on incisors.Results: The median difference (95%CI) in time to intubation suggested that CMAC was better than KVL in normal airway (-9.0[-13.0 to-6.0], p < 0.001), rigid neck (-12.0[-18.0 to -6.5], p < 0.001) and micrognathia (-16.5[-20.0 to -13.5], p < 0.001). When compared to DL, CMAC was better for micrognathia (-8.0[-5.5 to-10.5], p = 0.001) but comparable for normal airway and rigid neck. C-MAC also exerted the least force on incisors, minimizing dental trauma.Conclusion: The C-MAC VL demonstrated superior performance across all airway conditions, offering faster, safer, and easier NTI, making it the preferred device in challenging scenarios.Trial registration: Clinical Trial Registry of India: (CTRI/2022/05/042821) www.ctri.nic.in.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"633-641"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144061259","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Diaphragm neurostimulation in mechanical ventilation: current status and future prospects. 膈神经刺激在机械通气中的应用现状及展望。

Expert review of medical devices Pub Date : 2025-06-01 Epub Date: 2025-05-15 DOI: 10.1080/17434440.2025.2504454

Elizabeth C Rohrs, Steven Reynolds, Martin Dres

{"title":"Diaphragm neurostimulation in mechanical ventilation: current status and future prospects.","authors":"Elizabeth C Rohrs, Steven Reynolds, Martin Dres","doi":"10.1080/17434440.2025.2504454","DOIUrl":"10.1080/17434440.2025.2504454","url":null,"abstract":"Introduction: Diaphragm neurostimulation is a muscle stimulation technique that, through electrodes placed directly on or at the vicinity of the phrenic nerves, induces diaphragm contractions independently of the patient's cooperation. Recently, the technical development of temporary diaphragm neurostimulation devices has paved the way for a new era in the management of critically ill patients.Areas covered: In this review, we describe the latest technical developments in diaphragm neurostimulation and its physiological effects. We searched MEDLINE of experimental and clinical studies in English language published from database inception until 31 October 2024. We also discuss the advances in terms of patients centered outcomes and the key areas for improvement. Lastly, we introduce possible future directions and the novel improvements in patient care.Expert opinion: The research on diaphragm neurostimulation promise as an emerging intervention which addresses common complications associated with mechanical ventilation. Large-scale clinical trials are necessary to validate diaphragm neurostimulation efficacy and safety in humans, establish treatment protocols, and determine cost-effectiveness, all of which are essential for diaphragm neurostimulation to be widely accepted in clinical practice.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"595-603"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144083025","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Redo aortic root - complexity vs simplicity with choice of device selected. 重做主动脉根部-复杂与简单，选择设备。

Expert review of medical devices Pub Date : 2025-06-01 Epub Date: 2025-04-23 DOI: 10.1080/17434440.2025.2494641

Christopher He, Elizabeth L Norton, Edward P Chen

{"title":"Redo aortic root - complexity vs simplicity with choice of device selected.","authors":"Christopher He, Elizabeth L Norton, Edward P Chen","doi":"10.1080/17434440.2025.2494641","DOIUrl":"10.1080/17434440.2025.2494641","url":null,"abstract":"Introduction: The field of cardiac surgery continues to evolve significantly and one such example of advancement is aortic root replacement. In the setting of prior cardiac surgery, operative complexity increases due to adhesions, surgically-altered anatomy, and previously implanted prosthetic graft material. Device choice plays a significant role in balancing operative complexity with achieving simplicity and optimal clinical outcomes.Areas covered: This review explores the critical considerations necessary in performing redo aortic root surgery and the impact that device selection can have on the procedural complexity and clinical outcomes. This review was formulated by a systematic identification of published and unpublished laboratory and clinical studies evaluating these technologies.Expert opinion: Redo aortic root surgery represents one of the most challenging procedures in cardiac surgery, and the choice of both surgical technique and prosthetic device used are critical factors which influence the clinical success of the operation and the long-term outcomes for patients. By understanding the unique challenges of root replacement in a reoperative setting and the characteristics of different prosthetic devices, a tailored approach must be employed toward the best possible outcomes.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"555-568"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143995238","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Comparative validation of handheld fractional exhaled nitric oxide measurements. 手持式分数呼气一氧化氮测量的比较验证。

Expert review of medical devices Pub Date : 2025-06-01 Epub Date: 2025-04-29 DOI: 10.1080/17434440.2025.2499652

Sanne van Deelen, Gerdien A Tramper-Stranders, Rudi W Hendriks, Marcel J T Reinders, Gert-Jan Braunstahl

{"title":"Comparative validation of handheld fractional exhaled nitric oxide measurements.","authors":"Sanne van Deelen, Gerdien A Tramper-Stranders, Rudi W Hendriks, Marcel J T Reinders, Gert-Jan Braunstahl","doi":"10.1080/17434440.2025.2499652","DOIUrl":"10.1080/17434440.2025.2499652","url":null,"abstract":"Background: Fractional exhaled nitric oxide (FeNO) is a noninvasive method to determine the degree of airway inflammation. Handheld devices such as the Vivatmo Me are used for home monitoring. Differences were found between the Vivatmo Me and standard measurements with the NIOX VERO. Therefore, we aimed to determine the accuracy of the Vivatmo Me for FeNO measurements.Methods: Adult patients with an appointment for FeNO-measurement according to regular care, were invited to perform the FeNO measurement with both devices. From these measurements the FeNO values were compared, and the device user-friendliness was determined.Results: One hundred and sixty-four patients were included. The number of attempts needed for a successful measurement and the failure rate were higher with the Vivatmo Me. Although the measurements were highly correlated, a significant difference (p < 0.001) was found between FeNO values measured with both devices. From the Vivatmo measurements, 32% did not fall within the claimed accuracy ranges. A linear correction on the FeNO values reduced this number.Conclusion: Our findings indicate that the Vivatmo Me does not comply with the claimed accuracy of clinical FeNO measurements and the measurement is challenging to perform. By applying the proposed correction, the comparative validity of the FeNO measurement improves and therefore its clinical usefulness.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"643-650"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144028348","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0