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

Clinical guidance and expert opinion on the use of prostatic urethral lift implants for benign prostatic hyperplasia. 前列腺尿道提升植入物治疗良性前列腺增生的临床指导及专家意见。

IF 2.7

Expert review of medical devices Pub Date : 2026-09-01 Epub Date: 2026-07-31 DOI: 10.1080/17434440.2026.2711873

Eviatar Fields, Hasan S Al-Hasani, Jennifer Polo, Naeem Bhojani, Dean Elterman, Bilal Chugthai

{"title":"Clinical guidance and expert opinion on the use of prostatic urethral lift implants for benign prostatic hyperplasia.","authors":"Eviatar Fields, Hasan S Al-Hasani, Jennifer Polo, Naeem Bhojani, Dean Elterman, Bilal Chugthai","doi":"10.1080/17434440.2026.2711873","DOIUrl":"10.1080/17434440.2026.2711873","url":null,"abstract":"Introduction: Minimally invasive surgical therapies (MISTs) for benign prostatic hyperplasia (BPH) are increasingly favored for their efficacy in symptom relief and reduced morbidity. Prostatic urethral lift has gained traction in the last decade due to its non-ablative properties and favorable clinical outcomes.Areas covered: In this article, we provide a narrative review including articles prior to July 2026 focusing on prostatic urethral lift technology. We provide a brief technical overview of the implant and implantation process, outlining key differences in the first- and second-generation systems. We provide clinical evidence demonstrating its safety and efficacy in relieving prostate symptoms, reviewing some of the pivotal and recent trials in men with classical BPH and those with median lobe enlargement.Expert opinion: Prostatic urethral lift offers patients a unique intermediate option between medical and ablative surgical management. It is particularly well-suited for younger men with a prostate volume of 30-80 cc, especially for those whom preservation of sexual and erectile function is a priority or who are not prepared for the morbidity associated with other surgical therapies. Its simplicity and ability to be performed under local anesthetic allow it to be adapted to an outpatient setting.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"991-997"},"PeriodicalIF":2.7,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148611387","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

Left bundle branch pacing vs biventricular pacing in heart failure patients undergoing cardiac resynchronization therapy: an updated systematic review and meta-analysis. 接受心脏再同步化治疗的心力衰竭患者左束支起搏与双心室起搏：最新的系统回顾和荟萃分析。

IF 2.7

Expert review of medical devices Pub Date : 2026-09-01 Epub Date: 2026-08-03 DOI: 10.1080/17434440.2026.2711869

Muhammad Asad Jahangir, Ahmad Hassan, Affaf Mahmood, Maaz Amir, Bakhtawar Khalid, Sameen Habib, Muhammad Salayh Khan, Aminah Farrukh, Ramisha Tahir, Fiza Waseem, Hafiz Asad Ullah, Rameen Khan, Arbab Sarfraz, Ali Raza, Ubaid Ur Rehman, Abdul Haseeb Hasan

{"title":"Left bundle branch pacing vs biventricular pacing in heart failure patients undergoing cardiac resynchronization therapy: an updated systematic review and meta-analysis.","authors":"Muhammad Asad Jahangir, Ahmad Hassan, Affaf Mahmood, Maaz Amir, Bakhtawar Khalid, Sameen Habib, Muhammad Salayh Khan, Aminah Farrukh, Ramisha Tahir, Fiza Waseem, Hafiz Asad Ullah, Rameen Khan, Arbab Sarfraz, Ali Raza, Ubaid Ur Rehman, Abdul Haseeb Hasan","doi":"10.1080/17434440.2026.2711869","DOIUrl":"10.1080/17434440.2026.2711869","url":null,"abstract":"Introduction: To compare the efficacy and safety of left bundle branch pacing (LBBP) versus biventricular pacing (BVP) in patients with heart failure undergoing cardiac resynchronization therapy (CRT), we conducted an updated systematic review and meta-analysis.Methods: PubMed, Cochrane Library, ScienceDirect, and Embase, were searched through February 2026. Randomized controlled trials and cohort studies comparing LBBP with BVP were included. Risk of bias was assessed using RoB 2.0 for randomized trials and ROBINS-I for observational studies. Data were pooled using fixed- or random-effects models according to heterogeneity and expressed as odds ratios (OR) or mean differences (MD) with 95% confidence intervals (CI).Results: Twenty-four studies (9,278 patients) were included. Compared with BVP, LBBP reduced fluoroscopy time (MD -7.00, 95% CI -9.99 to -4.01) and procedural duration (MD -23.62, 95% CI -35.29 to -11.95), with similar success rates. LBBP improved CRT response (OR 1.85, 95% CI 1.06-3.23), super-response (OR 1.56, 95% CI 1.38-1.77), QRS duration (MD -17.11 95% CI -21.02 to -13.20), and LVEF (MD 3.58, 95% CI 2.95 to 4.22). LBBP also lowered all-cause mortality (OR 0.57, 95% CI 0.48 to 0.68) and heart failure hospitalization (OR 0.50, 95% CI 0.43 to 0.57].Conclusions: LBBP appears superior to BVP in improving electrical, structural, and clinical outcomes while maintaining comparable safety.Protocol registration number: CRD420261291248, and is available at: https://www.crd.york.ac.uk/PROSPERO/view/CRD420261291248.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1069-1087"},"PeriodicalIF":2.7,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148623219","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

Recent advances in PMMA bone cement-loaded delivery systems for the treatment of open bone defect infections. PMMA骨水泥载药系统治疗开放性骨缺损感染的最新进展。

IF 2.7

Expert review of medical devices Pub Date : 2026-09-01 Epub Date: 2026-07-26 DOI: 10.1080/17434440.2026.2691192

Haitao Liu, Yu Bo, Pengcheng Gao, Zhizhong Li, Shaodong Qiu, Gangning Feng, Zongqiang Yang, He Zhang, Zhanhu Mi

{"title":"Recent advances in PMMA bone cement-loaded delivery systems for the treatment of open bone defect infections.","authors":"Haitao Liu, Yu Bo, Pengcheng Gao, Zhizhong Li, Shaodong Qiu, Gangning Feng, Zongqiang Yang, He Zhang, Zhanhu Mi","doi":"10.1080/17434440.2026.2691192","DOIUrl":"10.1080/17434440.2026.2691192","url":null,"abstract":"Introduction: Postoperative fracture infection can cause serious limb deformity and dysfunction. Polymethylmethacrylate (PMMA) bone cement is widely used for treating open bone defect infections, yet its limitations necessitate a review of current strategies and future directions.Areas covered: This review summarizes PMMA's history, biological properties, and drug-loaded applications in orthopedics, focusing on antibiotic combination therapy for fracture defects. Literature was sourced from PubMed and Web of Science, covering studies from the clinical introduction of PMMA to recent advances published up to 2025.Expert opinion: PMMA bone cement remains a critical antibiotic delivery system. While modified composites and combination strategies show promise in improving release profiles and osteogenic activity, challenges such as non-degradability, optimal pore formation, and clinical translation of bioactive additives persist. Future research should prioritize developing fully biodegradable, highly osteogenic PMMA alternatives and establishing standardized protocols for antibiotic combination therapies. The ideal solution would balance mechanical strength, drug release kinetics, and complete resorption, potentially transforming infected bone defect management within five years.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1033-1041"},"PeriodicalIF":2.7,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148595226","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

Percutaneous left ventricular assist device in cardiogenic shock associated with and without acute myocardial infarction: a real-world retrospective cohort study. 经皮左心室辅助装置在伴有或不伴有急性心肌梗死的心源性休克中的应用：一项真实世界的回顾性队列研究。

IF 2.7

Expert review of medical devices Pub Date : 2026-09-01 Epub Date: 2026-07-29 DOI: 10.1080/17434440.2026.2710388

Roopeessh Vempati, John Gallagher, Haidar Hajeh, Khaled Elnaggar, Ali Awad, Prakash Gupta, Joud Fahed, Muhammad Burhan, M Chadi Alraies

{"title":"Percutaneous left ventricular assist device in cardiogenic shock associated with and without acute myocardial infarction: a real-world retrospective cohort study.","authors":"Roopeessh Vempati, John Gallagher, Haidar Hajeh, Khaled Elnaggar, Ali Awad, Prakash Gupta, Joud Fahed, Muhammad Burhan, M Chadi Alraies","doi":"10.1080/17434440.2026.2710388","DOIUrl":"10.1080/17434440.2026.2710388","url":null,"abstract":"Background: Percutaneous left ventricular assist devices (pLVAD, such as Impella), are increasingly used for cardiogenic shock (CS). Outcomes may differ between acute myocardial infarction-related CS (AMI-CS) and non-AMI CS due to differing pathophysiology and trajectories.Methods: Using the USA TriNetX Network (2016-2024), we identified adults with CS treated withpLVAD. AMI-CS was defined by MI within seven days of implantation; non-AMI CS included all patients with CS not attributable to acute MI, representing heterogeneous etiologies such as decompensated cardiomyopathy, myocarditis, valvular failure, pulmonary vascular causes, and arrhythmic shock. Patients with recent coronary artery bypass graft (CABG) were excluded. Propensity matching produced two balanced cohorts (n = 2,026 each).Results: Among 6,873 AMI-CS and 4,521 non-AMI CS patients, matched groups were similar (mean age 63 years, 26% female). AMI-CS had higher mortality at 30 days (hazard ratio [HR] 1.19, p = 0.002), 90 days (HR 1.13, p = 0.02), and 180 days (HR 1.14, p = 0.007). Heart failure (HF) exacerbations (HR 1.21, p < 0.001) and pulmonary edema (HR 1.23, p = 0.005) were also more common in AMI-CS. Stroke, ventricular arrhythmias, cardiac arrest, acute kidney injury, major bleeding, vascular complications, and hemodialysis were comparable.Conclusion: AMI-CS patients supported with pLVAD experienced higher mortality and greater HF-related morbidity than non-AMI CS.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1125-1135"},"PeriodicalIF":2.7,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148611463","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

Current practices and limitations of testing procedures for rehabilitative and assistive hand exoskeletons. 康复和辅助手外骨骼测试程序的当前实践和局限性。

IF 2.7

Expert review of medical devices Pub Date : 2026-08-01 Epub Date: 2026-06-13 DOI: 10.1080/17434440.2026.2686757

Holly Alfs, Steve Davis, David Punt, Samia Nefti-Meziani

{"title":"Current practices and limitations of testing procedures for rehabilitative and assistive hand exoskeletons.","authors":"Holly Alfs, Steve Davis, David Punt, Samia Nefti-Meziani","doi":"10.1080/17434440.2026.2686757","DOIUrl":"10.1080/17434440.2026.2686757","url":null,"abstract":"Introduction: The development of hand exoskeletons for the assistance and rehabilitation of dexterity impairments has been ongoing for decades, although advancements are hindered by inconsistent evaluation metrics.Areas covered: This review aims to identify all methods used to test and compare the devices. Using these, it outlines an evaluative framework to standardize research and reduce heterogeneity moving forward. Literature from 2010 to 2025 was searched for using Scopus, IEEE Xplore, and PubMed. This comprised of publications detailing each exoskeleton and overall reviews of the technologies. Current testing methods were identified within mathematical and computational modeling, non-clinical prototype testing, clinical feasibility trials, and rehabilitative trials.Expert opinion: At present, clinical adoption of hand exoskeletons is limited due to the lack of thorough, methodical analysis. The variation of assessment methods is partially attributed to the absence of suggested guidelines but may also be driven by intentions to mask device limitations. The current practices for theoretical analyses are sufficient for design optimization, verification, and defining control systems. However, both non-clinical and clinical prototype testing are used to validate device performances; therefore, the suggested standardized protocols would improve inter-device comparisons. This would produce faster advancements, leading to improved rehabilitation outcomes and patient independence.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"951-965"},"PeriodicalIF":2.7,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148201824","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

Correction. 修正。

IF 2.7

Expert review of medical devices Pub Date : 2026-08-01 Epub Date: 2026-03-12 DOI: 10.1080/17434440.2026.2643055

引用次数: 0

A profile on the Cefaly Dual trigeminal neurostimulator for acute and preventive migraine treatment: an overview of its safety and efficacy. Cefaly双三叉神经刺激器用于急性和预防性偏头痛治疗的概况：其安全性和有效性的概述。

IF 2.7

Expert review of medical devices Pub Date : 2026-08-01 Epub Date: 2026-06-25 DOI: 10.1080/17434440.2026.2693096

Aimen Vanood, Medha Tandon, Amaal J Starling

{"title":"A profile on the Cefaly Dual trigeminal neurostimulator for acute and preventive migraine treatment: an overview of its safety and efficacy.","authors":"Aimen Vanood, Medha Tandon, Amaal J Starling","doi":"10.1080/17434440.2026.2693096","DOIUrl":"10.1080/17434440.2026.2693096","url":null,"abstract":"Introduction: Migraine is one of the leading causes of disability worldwide. Neuromodulation is a non-pharmacologic class of treatment for migraine. Cefaly is a neuromodulatory device that modulates pain through peripheral nerve stimulation of the supraorbital and supratrochlear nerves, leading to central pain modulation through the trigeminal nucleus caudalis (TNC).Areas covered: This review article discusses the physiology of migraine with reference to neuromodulation, summarizes the available evidence for the use of Cefaly in acute and preventive treatment of migraine, including studies that led to its clearance by the Food and Drug Administration (FDA) and clinical trials ongoing at the time of this publication. We also review potential side effects and contraindications for using the device. Additionally, this article contrasts Cefaly with other available neuromodulation devices for management of migraine.Expert opinion: Cefaly is a well-tolerated, non-pharmacologic treatment option for both acute and preventive management of migraine. The available evidence, while moderate in quality, demonstrates efficacy in reducing migraine frequency, migraine attack pain relief, and acute medication use across diverse populations. Its favorable safety profile makes it a particularly feasible and valuable options for patients who have comorbid medical conditions, polypharmacy, or who prefer a non-drug option to care.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"893-903"},"PeriodicalIF":2.7,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148304377","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

Hearing aids in low- and middle-income countries: from evidence to scale. 中低收入国家的助听器：从证据到规模。

IF 2.7

Expert review of medical devices Pub Date : 2026-08-01 Epub Date: 2026-07-14 DOI: 10.1080/17434440.2026.2701375

De Wet Swanepoel, Caitlin Frisby, Vinay Manchaiah

{"title":"Hearing aids in low- and middle-income countries: from evidence to scale.","authors":"De Wet Swanepoel, Caitlin Frisby, Vinay Manchaiah","doi":"10.1080/17434440.2026.2701375","DOIUrl":"10.1080/17434440.2026.2701375","url":null,"abstract":"Introduction: Hearing loss affects more than 1.5 billion people globally, with nearly 80% of disabling cases in low- and middle-income countries (LMICs). Despite being the most established rehabilitation technology, fewer than 10% of those in need in LMICs possess them, with rates as low as 2% across Africa and Southeast Asia.Areas covered: This review synthesizes evidence on barriers to hearing aid access in LMICs, including workforce shortages, prohibitive costs and trade barriers, geographic centralization, and stigma across internalized, social, and structural dimensions, and evaluates strategies to overcome them. These include task-sharing using community health workers (CHWs), mobile health (mHealth) and tele-audiology, preset and over-the-counter (OTC) hearing aids, rechargeable devices, mHealth adherence support, and health systems policy reforms.Expert opinion: Closing this gap requires a shift toward decentralized, community-based care supported by digital technologies. Evidence supports CHW-facilitated hearing aid provision with structured counseling and mHealth acclimatization support, as a feasible, effective, and acceptable rehabilitation model. Future progress depends on embedding hearing care within universal health coverage, reforming cost-inflating trade policies, and investing in implementation science to evaluate the fidelity, scalability, and sustainability of effective models. These models also apply to underserved populations in high-income countries.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"967-980"},"PeriodicalIF":2.7,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148407499","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 review of coronary CT angiography versus conventional catheter angiography: diagnostic value, clinical outcomes, and underlying technical principles. 冠状动脉CT血管造影与常规导管血管造影的比较回顾：诊断价值、临床结果和潜在的技术原则。

IF 2.7

Expert review of medical devices Pub Date : 2026-08-01 Epub Date: 2026-07-02 DOI: 10.1080/17434440.2026.2698675

Saad Masri, Mana Sezdi

{"title":"Comparative review of coronary CT angiography versus conventional catheter angiography: diagnostic value, clinical outcomes, and underlying technical principles.","authors":"Saad Masri, Mana Sezdi","doi":"10.1080/17434440.2026.2698675","DOIUrl":"10.1080/17434440.2026.2698675","url":null,"abstract":"Introduction: The diagnostic pathway for coronary artery disease (CAD) is actively transitioning toward noninvasive risk stratification. This review contrasts Coronary Computed Tomography Angiography (CCTA) with Invasive Coronary Angiography (ICA) to clarify their respective roles and physical limitations in modern cardiovascular care.Areas covered: A comprehensive literature search was conducted across PubMed, Web of Science, and Scopus for articles published between January 2015 and March 2026. We evaluate the physical principles, diagnostic performance, and clinical utility of both imaging modalities. The discussion includes recent breakthroughs like Photon-Counting Detector CT (PCD-CT), which improves stenosis grading in heavily calcified lesions. We also explore CCTA's expansion beyond basic morphology into functional and prognostic assessments via CT-derived Fractional Flow Reserve (FFR-CT), artificial intelligence algorithms (AI-QCT), and the Pericoronary Fat Attenuation Index (FAI).Expert opinion: Current clinical evidence supports a 'CCTA-first' approach for stable chest pain. CCTA functions as the primary noninvasive gatekeeper and platform for plaque phenotyping, while ICA remains the irreplaceable standard for high-risk diagnostics and targeted therapeutic revascularization.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"943-950"},"PeriodicalIF":2.7,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148364397","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

Pre-market clinical investigation approval pathways and the role of Early Feasibility Studies for medical devices: a scoping review to guide EU policy. 上市前临床调查批准途径和医疗器械早期可行性研究的作用：指导欧盟政策的范围审查。

IF 2.7

Expert review of medical devices Pub Date : 2026-08-01 Epub Date: 2026-06-25 DOI: 10.1080/17434440.2026.2693727

Helen Banks, Maria Luisa Buzelli, Ornella Tangila Kayembe, Nicolas Martelli, Majella Geraghty, Giuditta Callea

{"title":"Pre-market clinical investigation approval pathways and the role of Early Feasibility Studies for medical devices: a scoping review to guide EU policy.","authors":"Helen Banks, Maria Luisa Buzelli, Ornella Tangila Kayembe, Nicolas Martelli, Majella Geraghty, Giuditta Callea","doi":"10.1080/17434440.2026.2693727","DOIUrl":"10.1080/17434440.2026.2693727","url":null,"abstract":"Introduction: Early Feasibility Studies (EFS) enable limited early-stage clinical evaluation of novel medical devices when non-clinical testing is insufficient to inform design, safety, or performance. While the US Food and Drug Administration has an established EFS program, the EU lacks a dedicated framework, creating uncertainty for innovators and regulators.Areas covered: This scoping review examines pre-market regulatory pathways for elements critical for EFS implementation. A literature search was conducted in PubMed, Scopus, and Web of Science without time or geographic restrictions. Eight key dimensions were identified, primarily across EU and US systems: regulatory frameworks; eligibility criteria and preclinical evidence; iterative innovation mechanisms; early dialogue; structural and medico-legal challenges; clinical site capacity; risk management; and patient communication, involvement, and safety. The FDA model supports EFS through clear guidance, flexible testing, early dialogue, and support for protocol and device iteration. In contrast, EU regulation acknowledges early investigations but lacks a dedicated framework, resulting in fragmented implementation.Expert opinion: A coherent EU EFS framework could strengthen patient protection by improving regulatory clarity, oversight, and the quality and timeliness of early-stage evidence, accelerating innovation and strengthening European competitiveness. Priority actions include formal guidance, structured early dialogue, capacity building, harmonized liability, and enhanced patient involvement.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"879-892"},"PeriodicalIF":2.7,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148298015","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