Clinical Perspective-Early Feasibility Device Medical Studies in the United States Time for More Than Regulatory Reform

Holmes David R. Jr.; Shuren Jeff; Califf Robert; Zuckerman Bram; Abel Dorothy; Farb Andrew; Leon Martin; Mack Michael

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Clinical Perspective-Early Feasibility Device Medical Studies in the United States Time for More Than Regulatory Reform

机译：临床观点-在美国进行早期可行设备医学研究的时机尚待监管改革

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《JACC. Cardiovascular interventions 》 |2016年第6期| 共3页
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Holmes David R. Jr.; Shuren Jeff; Califf Robert; Zuckerman Bram; Abel Dorothy; Farb Andrew; Leon Martin; Mack Michael;
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1. Clinical Perspective-Early Feasibility Device Medical Studies in the United States Time for More Than Regulatory Reform [J] . Holmes David R. Jr., Shuren Jeff, Califf Robert, JACC. Cardiovascular interventions . 2016 ,第6期

机译：临床观点-在美国进行早期可行设备医学研究的时机尚待监管改革
2. Overcoming the Challenges of Conducting Early Feasibility Studies of Medical Devices in the United States [J] . Holmes David R. Jr., Califf Robert, Farb Andrew, Journal of the American College of Cardiology . 2016 ,第17期

机译：克服在美国进行医疗器械早期可行性研究的挑战
3. Overcoming the Challenges of Conducting Early Feasibility Studies of Medical Devices in the United States [J] . Holmes David R. Jr., Califf Robert, Farb Andrew, Journal of the American College of Cardiology . 2016 ,第17期

机译：克服了对美国医疗器械的早期可行性研究造成挑战
4. Attempting to Use MetaMap in Clinical Practice: A Feasibility Study on the Identification of Medical Concepts from Italian Clinical Notes [C] . Emma CHIARAMELLO, Alessia PAGLIALONGA, Francesco PINCIROLI, HEC (Conference) . 2016

机译：试图在临床实践中使用METAMAP：从意大利临床票据鉴定医学概念的可行性研究
5. Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving US Food and Drug Administration Premarket Approval in 2010 and 2011. [D] . Rathi, Vinay Kumar. 2016

机译：在2010年和2011年获得美国食品药品监督管理局上市前批准的高风险治疗性医疗器械整个产品生命周期中进行的临床研究。
6. A heel-strike real-time auditory feedback device to promote motor learning in children who have cerebral palsy: a pilot study to test device accuracy and feasibility to use a music and dance-based learning paradigm [O] . Jaswandi Tushar Pitale, John H. Bolte IV 2018

机译：脚后跟打击实时听觉反馈设备可促进脑瘫患儿的运动学习：一项试行研究用于测试设备的准确性和使用基于音乐和舞蹈的学习范例的可行性
7. Poster Session 3The imaging examination and quality assessmentP626Value of mitral and tricuspid annular displacement to assess the interventricular systolic relationship in severe aortic valve stenosis : a Pilot studyP627Follow-up echocardiography in asymptomatic valve disease: assessing the potential economic impact of the European and American guidelines in a dedicated valve clinic, compared to standard care.P628The tricuspid valve: identification of optimal view for assessing for prolapseP629Right atrial volume by two-dimensional echocardiography in healthy subjectsP630Disturbance of inter and intra atrial conduction assessed by tissue doppler imaging in patients with medicaly controlled hypertension and prehypertension.P631Liver stiffness by shear wave elastography, new noninvasive and quantitative tool for acute variation estimation of central venous pressure in real-time?P632Weak atrial kick contribution is associated with a risk for heart failure decompensationP633Usefulness of wave intensity analysis in predicting the response to cardiac resynchronization therapyP634Early subclinical left ventricular systolic and diastolic dysfunction in gestational hypertension and preeclampsiaP635Clinical comparison of three different echocardiographic methods for left ventricular ejection fraction and LV end diastolic volume measurementP636Assessment of right ventricular-arterial coupling parameters by 3D echocardiography in patients with pulmonary hypertension receiving specific vasodilator therapyP637Prediction of right ventricular failure after left ventricular assist device implant: assessing usefulness of standard and strain echocardiographyP638Kinematic analysis of diastolic function using the novel freely available software Echo E-waves - feasibility and reproducibilityP639Evaluation of coronary flow velocity by Doppler echocardiography in the treatment of hypertension with the ARB: correlation to the histological cardiac fibrosisP640The clinical significance of limited apical ischaemia and the prognostic value of stress echocardiography - A contemporary study from a high volume centerP641Effects of intermediate stenosis of left anterior descending coronary artery on survival in patients with chronic total occlusion of right coronary arteryP642Left ventricular remodeling after a first myocardial infarction in patients with preserved ejection fraction at dischargeP643Left atrial size and acute coronary syndromes. Let is make simple.P644Influence of STEMI reperfusion strategy on systolic and diastolic functionP645Aortic valve resistance risk-stratifies low-gradient severe aortic stenosisP646Does permanent pacemaker implantation complicate the prognosis of patients after transcatheter aortic valve implantation?P647Influence of metabolic syndrome and diabetes on progression of calcific aortic valve stenosis - The COFRASA - GENERAC StudyP648Low referral for aortic valve replacement accounts for worse long-term outcome in low versus high gradient severe aortic stenosis with preserved ejection fractionP649The impact of right ventricular function from aortic valve replacement: A randomised study comparing minimally invasive aortic valve surgery and conventional open heart surgery [O] . T. Ota, DNS Senaratne, NK. Preston, 2016

机译：海报课程3年度成像检查和质量评估P626尺寸二尖瓣环形位移，评估严重主动脉瓣狭窄中的间隔收缩系统关系：无症状瓣膜病的先导术627推翻超声心动图：评估欧洲和美国指南的潜在经济影响专用阀门诊所，与标准Care.P628相比，Tricuspid阀门：鉴定通过在医疗主题的Hystantsp630中，通过组织多普勒成像在医疗和术语中的癌细胞癌和术语患者进行评估，通过二维超声心动图进行评估的最佳视图。 .p631抗剪力波弹性凝视，新的非侵入性和定量工具，用于实时急性变异估计中央静脉压力的急性变化？P632Weak心房踢贡献与心力衰竭分数的风险有关波强度分析预测心脏重新同步的响应治疗634亚临床左心室收缩和舒张性功能障碍，妊娠期高血压分数的三种不同超声心动仪和LV端舒张型方法的比较，3D超声心动图右心室凝血率测量3636分类在患有肺动脉高压的患者中，左心室辅助装置植入后接受特异性血管扩张器治疗637预测右心室失效：评估使用新颖的自由可用的软件回声电子波的标准和菌株超声心动图338云分析的标准和菌株超声心动图638云分析 - 可行性和再现冠状动脉速度的可行性和再现率。多普勒超声心动图在治疗高血压与arb中：相关性与组织学心肌纤维化p640的相关性李的临床意义紧张的缺血性和应激超声心动图的预后价值 - 一种高批量中心的当代研究，来自左前期下降冠状动脉中间狭窄患者中间狭窄患者急性闭塞患者患者患者患者第一次心肌梗死后的慢性冠状动脉间梗死患者存活的现代研究排出的射血分数在排出的343夜心房尺寸和急性冠状动脉综合征处。让令人生意的是STEMIESTOMELETERIC功能的STEMIEST.P644。在收缩和舒张功能上进行STEMI和舒张型阀门电阻危险危险率低梯度严重主动脉鼻窦646doe永久性起搏器植入使经截觉管主动脉瓣植入后的患者预后复杂化吗？P647型综合征和糖尿病患者的进展主动脉瓣狭窄 - Cofrasa - Generac STOMP648LOW用于主动脉瓣膜置换术的转诊表明，低梯度严重主动脉狭窄的更差的长期结果，并具有射血瓣膜置换术射精术中的抗锻术术造成的影响：随机研究比较微创主动脉阀门手术和常规开放式心脏手术
8. Regulatory Responsibilities of the Bureau of Medical Devices. Module V: Overview of the Medical Device Amendments. Leader Guide and Student Workbook [R] . 1980

机译：医疗器械局的监管责任。第五单元：医疗器械修正案概述。领导指南和学生作业簿

Clinical Perspective-Early Feasibility Device Medical Studies in the United States Time for More Than Regulatory Reform

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