Expert review of medical devices最新文献

Transperineal prostate biopsy using the PrecisionPoint transperineal access system for prostate cancer diagnosis - a new standard of care.

Expert review of medical devices Pub Date : 2025-04-07 DOI: 10.1080/17434440.2025.2490753

Charlton Martin, Flavio Ordones

引用次数: 0

An overview of the freestyle libre monitoring system for individuals with type 1 and type 2 diabetes.

Expert review of medical devices Pub Date : 2025-04-04 DOI: 10.1080/17434440.2025.2489494

Sergio Di Molfetta, Antonio Cutruzzolà, Agostino Gnasso, Concetta Irace

{"title":"An overview of the freestyle libre monitoring system for individuals with type 1 and type 2 diabetes.","authors":"Sergio Di Molfetta, Antonio Cutruzzolà, Agostino Gnasso, Concetta Irace","doi":"10.1080/17434440.2025.2489494","DOIUrl":"https://doi.org/10.1080/17434440.2025.2489494","url":null,"abstract":"Introduction: Diabetes is a chronic disease with high prevalence, necessitating advanced technology to achieve glycemic targets and reduce complications. Continuous glucose monitoring (CGM) has become a cornerstone in diabetes management, with the Freestyle Libre (FSL) systems being some of the most widely used devices.Areas covered: This review focuses on FSL systems, each including an all-in-one sensor and transmitter, a handheld reader and a Mobile Medical App (MMA). Glucose data are uploaded to a dedicated cloud-based platform for analysis. Over the years, FSL has evolved with new features offering valuable support for individuals with diabetes, caregivers, and healthcare providers. Clinical trials and real-world studies have demonstrated efficacy and safety across diverse populations, including individuals with type 1 and type 2 diabetes, adolescents, and pregnant women with diabetes.Expert opinion: FSL is a user-friendly system that meets the needs of patients and health care providers. The MMA allows a review of glucose metrics and pattern identification, and supports educational strategies and patient-tailored treatment. Future advancements, including ketone monitoring, integration with wearable and other devices, and telemedicine applications, will further optimize diabetes care and prevention.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143782353","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

Focused ultrasound: focused on tremor.

Expert review of medical devices Pub Date : 2025-04-04 DOI: 10.1080/17434440.2025.2489493

Benjamin Davidson, Andres M Lozano

{"title":"Focused ultrasound: focused on tremor.","authors":"Benjamin Davidson, Andres M Lozano","doi":"10.1080/17434440.2025.2489493","DOIUrl":"https://doi.org/10.1080/17434440.2025.2489493","url":null,"abstract":"Introduction: Magnetic resonance-guided focused ultrasound (MRgFUS) has emerged as a leading noninvasive therapy for tremor, offering a precise, lesion-based alternative to deep brain stimulation (DBS) and traditional lesioning techniques. By using phased ultrasound arrays to focus energy at intracranial targets, MRgFUS allows for real-time visualization and monitoring, improving safety and efficacy. Initially developed for essential tremor (ET), MRgFUS-VIM-thalamotomy has gained widespread acceptance and is now a first-line option for tremor-dominant Parkinson's disease (TDPD) and other tremor syndromes.Areas covered: This review discusses the fundamental physics of focused ultrasound, key anatomical targets, and the clinical application of MRgFUS thalamotomy, pallidotomy, and subthalamotomy. Skull density ratio (SDR) and energy efficiency are highlighted as crucial factors affecting treatment outcomes. The evolution of MRgFUS as a bilateral treatment, along with the exploration of novel targets such as the pallidothalamic tract, is examined. Additionally, we discuss advancements in FUS neuromodulation, which could complement lesioning by providing temporary or reversible symptom relief.Expert opinion: MRgFUS is poised to further revolutionize tremor treatment with frameless technology, staged bilateral procedures, and the integration of neuromodulation. Future developments may allow for precise, adaptive therapies that enhance both efficacy and patient experience.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143784656","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

Clinical study of real-time three-dimensional echocardiography combined with radionuclide imaging to evaluate changes in cardiac function and synchronization before and after cardiac rehabilitation in patients with acute myocardial infarction.

Expert review of medical devices Pub Date : 2025-04-03 DOI: 10.1080/17434440.2025.2489497

Jinfang Cheng, Ning Li, Jun Xue, Xiaolong Mi

{"title":"Clinical study of real-time three-dimensional echocardiography combined with radionuclide imaging to evaluate changes in cardiac function and synchronization before and after cardiac rehabilitation in patients with acute myocardial infarction.","authors":"Jinfang Cheng, Ning Li, Jun Xue, Xiaolong Mi","doi":"10.1080/17434440.2025.2489497","DOIUrl":"https://doi.org/10.1080/17434440.2025.2489497","url":null,"abstract":"Objective: This research aimed to unveil the effects of real-time three-dimensional echocardiography (RT-3DE) combined with radionuclide imaging to evaluate changes in cardiac function and synchronization before and after cardiac rehabilitation in patients with acute myocardial infarction (AMI).Methods: RT-3DE and radionuclide imaging were performed after PCI (pre-rehabilitation) and the 8-week follow-up visit (post-rehabilitation). Relevant data were collected: heart rate (HR), left ventricular (LV) end-systolic volume (LVESV), LV end-diastolic volume (LVEDV), LV ejection fraction (LVEF), LV 16-segment maximum difference in time to minimum systolic volume (Tmsv-16-Dif), LV 16-segment standard deviation of time to minimum systolic volume (Tmsv-16-SD), Tmsv 16-Dif % and Tmsv 16-SD %, summed Stress Score (SSS), Summed Rest Score (SRS), and SDS (SRS-SSS).Results: At the 8-week follow-up after PCI, HR, LVEDV, LVESV, Tmsv-16-Dif, Tmsv-16-SD, Tmsv-16-Dif%, Tmsv-16-SD%, SSS, SRS, and SDS in the rehabilitation group were lower than those in the control group; LVEF in the rehabilitation group was higher than the control group.Conclusion: RT-3DE and radionuclide imaging can be used as a follow-up tool for evaluating LV function and synchronization changes after cardiac rehabilitation in patients with AMI undergoing PCI.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143775117","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

Effect of posterior decompression and bone grafting combined with minimally invasive percutaneous pedicle screw fixation on pain and functional recovery in patients with thoracolumbar spinal fractures.

Expert review of medical devices Pub Date : 2025-04-03 DOI: 10.1080/17434440.2025.2485291

Dong Chen, Pei Liu, Wenqi Song, Shenghe Liu

{"title":"Effect of posterior decompression and bone grafting combined with minimally invasive percutaneous pedicle screw fixation on pain and functional recovery in patients with thoracolumbar spinal fractures.","authors":"Dong Chen, Pei Liu, Wenqi Song, Shenghe Liu","doi":"10.1080/17434440.2025.2485291","DOIUrl":"10.1080/17434440.2025.2485291","url":null,"abstract":"Objective: This study aimed to investigate the effects of posterior decompression and bone grafting combined with minimally invasive percutaneous pedicle screw fixation (MIPSF) on pain relief and functional recovery in patients with thoracolumbar spinal fractures.Methods: This prospective, randomized controlled trial included 68 patients with thoracolumbar spinal fractures, who were divided into control and observation groups. Perioperative outcomes, visual analogue scale (VAS), Oswestry Disability Index (ODI), American Spinal Injury Association Impairment Scale, vertebral anterior height, vertebral sagittal index, Cobb's Angle, serum substance P (SP), serum cortisol (Cor), and C-reactive protein (CRP) levels, were evaluated. Postoperative complications were also recorded.Results: The observation group exhibited reduced operation time, intraoperative blood loss, drainage volume, and hospital stay, lower VAS and ODI scores, higher sensory and motor scores, improved injured vertebral anterior height and sagittal index, decreased kyphotic Cobb's angle, and lower serum SP, Cor, and CRP levels versus the control group (p < 0.05). The postoperative complication rate was 5.88% in the control group and 2.94% in the observation group (p > 0.05).Conclusion: The combination of posterior decompression, bone grafting, and MIPSF for thoracolumbar spine fractures results in less traumatic stress, improved postoperative pain management, and better recovery of spinal function.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-7"},"PeriodicalIF":0.0,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143712343","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

How robotic platforms are revolutionizing colorectal surgery techniques: a comparative review.

Expert review of medical devices Pub Date : 2025-04-03 DOI: 10.1080/17434440.2025.2486481

Mariam Hussain, Mona Jaffar-Karballai, Fatima Kayali, Matti Jubouri, Abedalaziz Omar Surkhi, Mohamad Bashir, Ali Murtada

{"title":"How robotic platforms are revolutionizing colorectal surgery techniques: a comparative review.","authors":"Mariam Hussain, Mona Jaffar-Karballai, Fatima Kayali, Matti Jubouri, Abedalaziz Omar Surkhi, Mohamad Bashir, Ali Murtada","doi":"10.1080/17434440.2025.2486481","DOIUrl":"10.1080/17434440.2025.2486481","url":null,"abstract":"Introduction: In the last two decades, robotic technology has fundamentally transformed the field of colorectal surgery by providing surgeons with unprecedented levels of precision and control. Nevertheless, robotic surgery presents certain challenges such as prolonged operating times, high costs, limited accessibility, and the necessity for specialized training.Areas covered: This comparative review analyzes the impact of robotic platforms on colorectal surgery and its outcomes, with the expanding market of this technology. The major databases including PubMed, Scopus, and Google Scholars were searched using the key term 'robotic assisted surgery,' 'robotic platforms,' and 'colorectal surgery' to identify relevant articles as of August 2024. The most utilized robotic platforms currently available on the market - Da Vinci, Versius, Senhance, and Revo-I - are compared through their peri- and post-operative outcomes, including operative duration, blood loss, hospitalization period, oncological outcomes, and cost, providing a comprehensive insight into the future of robotic-assisted colorectal surgery.Expert opinion: Robotic surgery significantly improves patient outcomes, including shorter postoperative recovery times and effective cancer resection margins. However, challenges faced with these platforms include longer intraoperative times, arm clashing, the need for bedside assistance, and cost. Nevertheless, with the evolution toward managing more complex rectal cancer cases and more challenging dissection planes, the need for robotic platforms will only grow.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-17"},"PeriodicalIF":0.0,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143744594","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

Assessment of patterns and predictors of medical device-related adverse events among oncology patients: a cross-sectional study at a tertiary care hospital.

Expert review of medical devices Pub Date : 2025-04-03 DOI: 10.1080/17434440.2025.2486471

Ashutosh Bhosale, Sarasa Meenakshi, Pavan Kumar Narapaka, Chauhan Richa, V Kalaiselvan, Sameer Dhingra, Nitesh Kumar, Radhakrishnan Rajesh, Krishna Murti

{"title":"Assessment of patterns and predictors of medical device-related adverse events among oncology patients: a cross-sectional study at a tertiary care hospital.","authors":"Ashutosh Bhosale, Sarasa Meenakshi, Pavan Kumar Narapaka, Chauhan Richa, V Kalaiselvan, Sameer Dhingra, Nitesh Kumar, Radhakrishnan Rajesh, Krishna Murti","doi":"10.1080/17434440.2025.2486471","DOIUrl":"10.1080/17434440.2025.2486471","url":null,"abstract":"Background: This study aims to identify patterns and predictors of medical device-related adverse events (MDAEs) among radiotherapy patients. Understanding MDAEs is crucial for optimizing patient safety during radiotherapy.Methodology: An observational study conducted from August to December 2023 involved 139 patients undergoing radiotherapy. Demographics, clinical characteristics, and AE reports were collected from patient datasheets and analyzed using SPSS Version 28.Results: Study findings revealed that patients with head and neck cancer were significantly associated with higher rates of skin (OR: 3.56, CI: 1.59-7.96) and mucous membrane reactions. Specific dose ranges, particularly 800-2800 cGy, also predict mucous membrane reactions (OR: 11.12, CI: 3.42-36.1). Furthermore, smokeless habits significantly influenced both skin (OR: 6.04, CI: 1.99-18.3) and mucous membrane reactions (OR: 8.77, CI: 2.57-29.9). In contrast, head and neck cancer patients had reduced likelihoods of pharynx reactions (OR: 0.37, CI: 0.13-1.00), particularly with doses between 2801 and 4800 cGy (OR: 0.45, CI: 0.96-21.6).Conclusion: This study identified a few significant predictors for the occurrence of various types of MDAEs among patients undergoing radiotherapy. Reporting MDAEs can prevent adverse effects caused by medical devices and enhance radiotherapy safety.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-11"},"PeriodicalIF":0.0,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143756887","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

Device profile of the integrated VitalFlow ECMO system.

Expert review of medical devices Pub Date : 2025-04-02 DOI: 10.1080/17434440.2025.2486479

Colin McCloskey, Yasir Abu-Omar, Julian C Bass, Laura Geer, Kathleen Stoddard, Cory M Alwardt, Lawrence Lambrecht, Bryan A Whitson

{"title":"Device profile of the integrated VitalFlow ECMO system.","authors":"Colin McCloskey, Yasir Abu-Omar, Julian C Bass, Laura Geer, Kathleen Stoddard, Cory M Alwardt, Lawrence Lambrecht, Bryan A Whitson","doi":"10.1080/17434440.2025.2486479","DOIUrl":"10.1080/17434440.2025.2486479","url":null,"abstract":"Introduction: Extracorporeal membrane oxygenation (ECMO) is a life support system composed of a pump, an oxygenator, hemocompatible component coating, and integrated monitoring. ECMO systems have evolved greatly since the initial intraoperative cardiopulmonary bypass circuits.Areas covered: This device profile describes the VitalFlow ECMO system, which has been cleared for ECMO use in the United States. This integrated system is designed for the care of the ECMO patient in the intensive care unit. This profile reviews design improvements to the centrifugal pump, the blood flow path and monitoring capabilities of the oxygenator, the hemocompatible surface coating, as well as the user-friendly console and the mobility-focused caddy. Capabilities and advantages over older designs are discussed.Expert opinion: All the components in modern ECMO machines (ie, centrifugal pumps, membrane oxygenators, coated blood circuits, integrated hemodynamic monitoring, and control devices) are individually important. The VitaFlow system integrates these components while still maintaining a degree of modularity, allowing for a small, highly human-compatible, highly physiologically supported system that causes minimal blood trauma and facilitates in-hospital transport and early mobilization.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-9"},"PeriodicalIF":0.0,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143756889","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

Expanding indications for drug-coated balloons in coronary artery disease.

Expert review of medical devices Pub Date : 2025-04-01 Epub Date: 2025-03-07 DOI: 10.1080/17434440.2025.2474179

Antonio Greco, Giacinto Di Leo, Marco Spagnolo, Daniele Giacoppo, Davide Capodanno

{"title":"Expanding indications for drug-coated balloons in coronary artery disease.","authors":"Antonio Greco, Giacinto Di Leo, Marco Spagnolo, Daniele Giacoppo, Davide Capodanno","doi":"10.1080/17434440.2025.2474179","DOIUrl":"10.1080/17434440.2025.2474179","url":null,"abstract":"Introduction: Despite technical advances in percutaneous coronary intervention (PCI) and new iterations of drug-eluting stents (DES), complications still occur, including stent thrombosis and in-stent restenosis (ISR). Drug-coated balloons (DCBs) provide a promising option for the treatment of coronary lesions - particularly when DES are undesirable or contraindicated - allowing for PCI without the implantation of metallic devices, thus adhering to the 'leave nothing behind' principle.Areas covered: A comprehensive literature search has been performed on PubMed, Web of Science and Cochrane, up to November 2024, with no significant restrictions. This article provides an overview of available DCB and summarizes the evidence supporting their use in different settings, including ISR, small-vessel disease, de novo large-vessel disease, and bifurcations.Expert opinion: Trials of DCB are heterogeneous with respect to population, sample size, follow-up, anatomical pattern, and device used. Furthermore, they usually have limited statistical power for clinical endpoints. Based on current knowledge, DES may be preferrable for DES-ISR, de novo lesions in large vessels and for the treatment of the main branch in true bifurcations, with DCB approved for small-vessel disease and selected ISR lesions. Ongoing trials are expected to provide definitive insights into the efficacy and safety of DCB in different scenarios.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"321-338"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143525572","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

Hospital medical device quality and safety monitoring using real-world data from Friuli Venezia Giulia regional health coordination agency.

Expert review of medical devices Pub Date : 2025-04-01 Epub Date: 2025-03-17 DOI: 10.1080/17434440.2025.2475242

Anna Flamigni, Marta Paulina Trojniak, Laura Distefano, Laura Mattioni, Domenica Cupo, Monica Zanier, Anna Arbo

{"title":"Hospital medical device quality and safety monitoring using real-world data from Friuli Venezia Giulia regional health coordination agency.","authors":"Anna Flamigni, Marta Paulina Trojniak, Laura Distefano, Laura Mattioni, Domenica Cupo, Monica Zanier, Anna Arbo","doi":"10.1080/17434440.2025.2475242","DOIUrl":"10.1080/17434440.2025.2475242","url":null,"abstract":"Background: The medical device and in vitro diagnostic industries are evolving with innovative, high-tech devices. New European regulations aim to create a sustainable, innovation-friendly regulatory framework.Research design and methods: This study is a retrospective analysis of complaints and incidents reported to the Regional Health Coordination Agency in 2023 in the Friuli Venezia Giulia region (Northeast Italy), in collaboration with IRCCS Burlo Garofolo. Safety and usability metrics were used to proactively and reactively monitor the quality and safety of hospital medical devices.Results: A total of 132 reports (57 incidents, 75 complaints) involving 101 different medical devices (0.5% of all ARCS devices) were analyzed; 24 reports classified as complaints were actually incidents. Risk class IIA and European Medical Device Nomenclature (EMDN) A devices were the most frequently reported. The analysis highlighted the need for improved compliance with reporting guidelines, proactive post-market surveillance, and enhanced institution-specific training programs to reduce risk and improve device performance.Conclusions: Proactive and reactive surveillance of medical devices in hospitals can be a useful tool to improve the safety and effectiveness of medical devices in real-world settings. Refining local reporting practices and improving user education will ultimately improve patient safety and outcomes, as well as hospital expenditure.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"369-377"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143560381","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