Expert review of medical devices最新文献_第5页

The evolving role of real-world evidence in medical device approvals in the United States. 真实世界证据在美国医疗器械审批中的演变作用。

Expert review of medical devices Pub Date : 2025-06-01 Epub Date: 2025-04-29 DOI: 10.1080/17434440.2025.2498458

Swarnali Goswami, Prajakta P Masurkar, Aashrey Kaul

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A new blood pressure monitoring app: an interview with Bernat Albinyana. 一款新的血压监测应用：采访伯纳特·阿尔比亚纳。

Expert review of medical devices Pub Date : 2025-06-01 Epub Date: 2025-04-23 DOI: 10.1080/17434440.2025.2496278

Bernat Albinyana

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Ceramic-based 3D printed bone graft in bone tissue reconstruction: a systematic review and proportional meta-analysis of clinical studies. 基于陶瓷的3D打印骨移植物在骨组织重建中的应用：临床研究的系统回顾和比例荟萃分析。

Expert review of medical devices Pub Date : 2025-06-01 Epub Date: 2025-04-18 DOI: 10.1080/17434440.2025.2492232

Maria Apriliani Gani, Honey Dzikri Marhaeny, Gyubok Lee, Siti Farah Rahmawati, Putu Diah Apri Anjalikha, Timothy Sugito, Ronan Lebullenger, I Ketut Adnyana, Kangwon Lee, Damien Brézulier

{"title":"Ceramic-based 3D printed bone graft in bone tissue reconstruction: a systematic review and proportional meta-analysis of clinical studies.","authors":"Maria Apriliani Gani, Honey Dzikri Marhaeny, Gyubok Lee, Siti Farah Rahmawati, Putu Diah Apri Anjalikha, Timothy Sugito, Ronan Lebullenger, I Ketut Adnyana, Kangwon Lee, Damien Brézulier","doi":"10.1080/17434440.2025.2492232","DOIUrl":"10.1080/17434440.2025.2492232","url":null,"abstract":"Introduction: This systematic review and proportional meta-analysis aims to evaluate the postoperative complication rate (CR%) of ceramic-based 3D-printed bone grafts based on the reported scientific articles conducted with human individuals.Methods: MEDLINE and SCOPUS were used as information sources. The synthesis of the study was carried out from studies with human individuals and the use of 3D-printed bone graft-ceramic as inclusion criteria. Cohen's kappa (κ) was calculated for interrater reliability. Qualitative analysis was performed based on the characteristics and outcomes of the individual study, and quantitative analysis was performed using proportional meta-analysis for CR%.Results: A total of 1352 records were identified through databases and resulted in 11 included studies (κ = 0.81-1.00) consisting of prospective clinical trials (64.63%), case series (16.67%), and case reports (18.18%). The overall postoperative complication rate was 14.3% (95% Cl: 0.19-53.6). The postoperative complication rate for studies conducted on the cranial defect, the maxillofacial-zygomatic defect, and the tibial-femoral defect was 2.7%, 11.1%, and 15.6%, respectively. This review also highlights common 3D printing techniques, materials, and grafs' characteristics, as well as their clinical applications.Conclusions: Ceramic-based 3D-printed bone grafts show potential as alternatives for bone tissue reconstruction.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"605-623"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144059111","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}

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^99mTc-labeled and functionalised plasmonic nanoparticles for photo-thermal therapy of primary tumours. 99mtc标记和功能化等离子体纳米粒子光热治疗原发性肿瘤。

Expert review of medical devices Pub Date : 2025-06-01 Epub Date: 2025-04-29 DOI: 10.1080/17434440.2025.2498459

Clelia Raso, Miriam Conte, Francesca Petronella, Viviana Frantellizzi, Flaminia De Cristofaro, Paolo Rosa, Maria Silvia De Feo, Giuseppe De Vincentis, Luciano De Sio

{"title":"99mTc-labeled and functionalised plasmonic nanoparticles for photo-thermal therapy of primary tumours.","authors":"Clelia Raso, Miriam Conte, Francesca Petronella, Viviana Frantellizzi, Flaminia De Cristofaro, Paolo Rosa, Maria Silvia De Feo, Giuseppe De Vincentis, Luciano De Sio","doi":"10.1080/17434440.2025.2498459","DOIUrl":"10.1080/17434440.2025.2498459","url":null,"abstract":"Introduction: Photo-thermal therapy (PTT) is an emerging biomedical field involving plasmonic nanoparticles (NPs), which efficiently convert light into heat due to a phenomenon known as Localized Surface Plasmon Resonance (LSPR). The ease of surface functionalization offered, especially by gold NPs (AuNPs), significantly betters their biocompatibility and stability. The radiolabeling of AuNPs with Technetium-99 (99mTc) allows for their precise spatial localization within the body at any depth and site through nuclear medicine imaging techniques. The combination of radioactive, optical, and thermo-ablative properties makes radiolabelled AuNPs a valid tool in theranostics. This review summarizes the main concepts behind PTT and the most recent clinical applications of plasmonic 99mTc-labeled NPs in cancer theranostic.Areas covered: Literature research of the last 20 years was conducted using Scopus and PubMed, including papers concerning technetium-radiolabelled NPs functionalized for cancer PTT.Expert opinion: AuNPs have been the subject of extensive research for diverse biomedical applications, including cancer diagnostics, therapy, and prevention, as well as drug delivery, sensing and cellular imaging. Despite the limited number of in vivo animal studies, radiolabeling and functionalizing the AuNPs with technetium represents a promising strategy to obtain a specific and efficient theranostic tool for nuclear medicine imaging.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"545-554"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144029023","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

Preparing for the new wave of intrathecal CNS therapies: innovations in drug delivery devices. 为鞘内中枢神经系统治疗的新浪潮做准备：药物输送装置的创新。

Expert review of medical devices Pub Date : 2025-06-01 Epub Date: 2025-04-28 DOI: 10.1080/17434440.2025.2499154

Manuel Menéndez González

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The potential power of Neuralink - how brain-machine interfaces can revolutionize medicine. 神经连接的潜在力量——脑机接口如何革新医学。

Expert review of medical devices Pub Date : 2025-06-01 Epub Date: 2025-04-28 DOI: 10.1080/17434440.2025.2498457

Rahul Kumar, Ethan Waisberg, Joshua Ong, Andrew G Lee

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Single-port robotic system - a paradigm shift in robot-assisted radical prostatectomy? 单端口机器人系统——机器人辅助根治性前列腺切除术的范式转变？

Expert review of medical devices Pub Date : 2025-06-01 Epub Date: 2025-04-28 DOI: 10.1080/17434440.2025.2499661

Oleksii Pisotskyi, Piotr Petrasz, Piotr Zorga, Marcin Gałęski, Paweł Szponar, Krzysztof Koper, Katarzyna Brzeżniakiewicz-Janus, Tomasz Drewa, Krzysztof Kaczmarek, Michał Cezary Czarnogórski, Jan Adamowicz

{"title":"Single-port robotic system - a paradigm shift in robot-assisted radical prostatectomy?","authors":"Oleksii Pisotskyi, Piotr Petrasz, Piotr Zorga, Marcin Gałęski, Paweł Szponar, Krzysztof Koper, Katarzyna Brzeżniakiewicz-Janus, Tomasz Drewa, Krzysztof Kaczmarek, Michał Cezary Czarnogórski, Jan Adamowicz","doi":"10.1080/17434440.2025.2499661","DOIUrl":"10.1080/17434440.2025.2499661","url":null,"abstract":"Introduction: Robotic-assisted radical prostatectomy (RARP) has become a cornerstone in the surgical management of prostate cancer. This study evaluates the potential of the Da Vinci single-port (SP) system, which represents a significant advancement in minimally invasive surgery.Areas covered: A narrative review was conducted using PubMed and Scopus databases to identify relevant studies published between January 2018 and February 2025. Search terms included 'single-port robotic prostatectomy,' 'Da Vinci SP system,' and 'robot-assisted radical prostatectomy.' Studies comparing SP and multi-port (MP) systems were prioritized. The SP system is discussed in terms of its technical innovations, including 360° operative field visualization, integrated optics and instruments, and enhanced depth perception. Clinical benefits, such as reduced blood loss, faster recovery, improved cosmetic outcomes, and reduced surgical trauma, are highlighted. Comparisons are drawn between the SP and multi-port systems, focusing on oncological and functional outcomes, as well as the challenges associated with the SP system's steeper learning curve.Expert opinion: The SP system holds great promise in advancing patient care in RARP, particularly through its minimally invasive approach. While achieving comparable outcomes to MP systems, it uniquely reduces surgical trauma. However, successful implementation requires overcoming technical challenges and adapting to the learning curve. Future research should focus on refining the technology and exploring its long-term impact on clinical outcomes.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"569-579"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144047204","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 effect of using a lower limb warming blanket combined with dexmedetomidine to prevent postoperative delirium and shivering in elderly patients undergoing spinal surgery. 下肢温毯联合右美托咪定预防老年脊柱手术患者术后谵妄和寒战的临床效果

Expert review of medical devices Pub Date : 2025-06-01 Epub Date: 2025-05-07 DOI: 10.1080/17434440.2025.2499149

Wei Fan, Murong Li, Qi Yao, Yanfei Hao, Gaoliang Ji

{"title":"Clinical effect of using a lower limb warming blanket combined with dexmedetomidine to prevent postoperative delirium and shivering in elderly patients undergoing spinal surgery.","authors":"Wei Fan, Murong Li, Qi Yao, Yanfei Hao, Gaoliang Ji","doi":"10.1080/17434440.2025.2499149","DOIUrl":"10.1080/17434440.2025.2499149","url":null,"abstract":"Objective: To observe the clinical effect of using a lower limb warming blanket combined with dexmedetomidine (DEX) to prevent postoperative delirium (POD) and shivering in elderly patients undergoing spinal surgery.Methods: A total of 160 elderly patients undergoing posterior spinal surgery under general anesthesia were selected and divided into a control group (group N), heating group (group T), DEX group (group D) and heating combined with DEX group (group TD), with 40 patients in each group. The intraoperative anesthesia dosage, changes in body temperature and heart rate at different time points (T1-T6) were compared, as well as the occurrence of postoperative shivering and POD in different groups.Results: During the entire procedure, the anesthesia dosage was lower in groups D and TD than in groups N and T (p < 0.05). The body temperature of groups N and D exhibited a downwards trend, which decreased significantly at T2. At T2-T4, the heart rate of groups D and TD was lower than that of groups N and T (p < 0.05).Conclusion: Using a lower limb heating blanket combined with DEX can effectively reduce the incidence of POD and postoperative shivering in elderly patients undergoing spinal surgery.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"625-631"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144052412","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

Cardiac imaging for the detection of ischemia: current status and future perspectives. 心脏成像检测缺血：现状和未来展望。

Expert review of medical devices Pub Date : 2025-06-01 Epub Date: 2025-05-12 DOI: 10.1080/17434440.2025.2500631

Carlos Rodriguez, Laura Pappas, Quang Le Hong, Laura Baquero, Eike Nagel

{"title":"Cardiac imaging for the detection of ischemia: current status and future perspectives.","authors":"Carlos Rodriguez, Laura Pappas, Quang Le Hong, Laura Baquero, Eike Nagel","doi":"10.1080/17434440.2025.2500631","DOIUrl":"10.1080/17434440.2025.2500631","url":null,"abstract":"Introduction: Coronary artery disease is the main cause of mortality worldwide mandating early detection, appropriate treatment, and follow-up. Noninvasive cardiac imaging techniques allow detection of obstructive coronary heart disease by direct visualization of the arteries or myocardial blood flow reduction. These techniques have made remarkable progress since their introduction, achieving high diagnostic precision. This review aims at evaluating these noninvasive cardiac imaging techniques, rendering a thorough overview of diagnostic decision-making for detection of ischemia.Areas covered: We discuss the latest advances in the field such as computed tomography angiography, single-photon emission tomography, positron emission tomography, and cardiac magnetic resonance; their main advantages and disadvantages, their most appropriate use and prospects. For the review, we analyzed the literature from 2009 to 2024 on noninvasive cardiac imaging in the diagnosis of coronary artery disease. The review included the 78 publications considered most relevant, including landmark trials, review articles and guidelines.Expert opinion: The progress in cardiac imaging is anticipated to overcome various limitations such as high costs, radiation exposure, artifacts, and differences in interpretation among observers. It is expected to lead to more automated scanning processes, and with the assistance of artificial intelligence-driven post-processing software, higher accuracy and reproducibility may be attained.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"581-594"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144001954","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

Differentiating between hepatocellular carcinoma and its mimickers using contrast-enhanced ultrasound with perflubutane microbubbles. 全氟丁烷微泡造影增强超声鉴别肝细胞癌及其模拟癌。

Expert review of medical devices Pub Date : 2025-05-28 DOI: 10.1080/17434440.2025.2481223

Yasunori Minami, Katsutoshi Sugimoto, Hidekatus Kuroda, Naohisa Kamiyama, Chikara Ogawa, Masatoshi Kudo

{"title":"Differentiating between hepatocellular carcinoma and its mimickers using contrast-enhanced ultrasound with perflubutane microbubbles.","authors":"Yasunori Minami, Katsutoshi Sugimoto, Hidekatus Kuroda, Naohisa Kamiyama, Chikara Ogawa, Masatoshi Kudo","doi":"10.1080/17434440.2025.2481223","DOIUrl":"https://doi.org/10.1080/17434440.2025.2481223","url":null,"abstract":"Introduction: Contrast-enhanced ultrasound (CEUS) is performed to non-invasively confirm a diagnosis of hepatocellular carcinoma (HCC) in high-risk patients. Typical imaging characteristics for HCC include non-rim arterial phase hyperenhancement (APHE), a washout appearance during the portal phase, and a defect in the Kupffer phase on CEUS using perflubutane microbubbles (Sonazoid). CEUS can show high diagnostic accuracy for HCC; however, we sometimes encounter challenging situations for diagnosing HCC.Areas covered: Some HCCs do not show APHE or the washout appearance, and other hepatic malignancies may exhibit similar imaging findings and be misdiagnosed as HCC. In addition, HCC needs to be differentiated from various types of hypervascular benign liver lesions. This review focuses on atypical imaging findings for HCC and typical imaging findings for common mimics of HCC as well as appropriate diagnostic workups for these lesions. Additionally, the literature review methodology, encompassing searches in PubMed, from January 1995 to January 2025, is briefly outlined.Expert opinion: Clinicians need to carefully consider the histopathological features, imaging characteristics, and differential diagnoses of hypervascular liver lesions in order to prevent a misdiagnosis and select appropriate treatment plans. A detailed understanding of typical and atypical imaging features may prevent the false-positive diagnosis of HCC.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144176241","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