The study is being conducted under an investigational device exemption granted by the FDA. According to the company, THUNDER is a multicenter, single-arm study evaluating patients with acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy. ...
SELUTION SLR是第一个也是唯一一个获得FDA IDE批准用于SFA和PPA适应症的莫司释放药物洗脱球囊(DEB)。 MedAlliance Enrolls First US Patient into its Third FDA IDE Study: SFA SELUTION4SFA SELUTION4SFA正在美国30多个中心以及全球另外10个中心进行 这项研究将招募300名患者,旨在证明SELUTION SLR优于球囊血管成...
(一)FDA 沟通: Pre-submission meeting Informal guidance meeting Early collaboration meetings Determination meeting Agreement meeting Submission issue meeting (二)FDA 审核 Feasibility Study可行性研究, 主要看安全性。 Pivotal Study 关键性研究, 主要看安全性和数据收集以及分析。 (三)FDA 审核结果 Approval 批准...
(一)FDA 沟通: Pre-submission meeting Informal guidance meeting Early collaboration meetings Determination meeting Agreement meeting Submission issue meeting (二)FDA 审核 Feasibility Study可行性研究, 主要看安全性。 Pivotal Study 关键性研究, 主要看安全性和数据收集以及分析。(三)FDA 审核结果 Approval 批准 ...
RapidPulse announced today that the US Food and Drug Administration (FDA) has agreed that the company can begin enrolment in an investigational device exemption (IDE) study of its novel and precise cyclic aspiration system. This will allow US and European patient enrolment in 2025 as...
当然,bridging study也有其他顾虑因素:1.临床剩余样本的丢失,在客观情况下,阳性对照组的临床剩余样本都不可能100%能应用于待注册试剂的bridging study研究中;2.在缺乏充足临床剩余样本的情况下,推算出来的伴随用药药效是否具有统计学意义。 所以,FDA都在该草稿指南中建议申办...
Because the study of a near-final or final device design takes place later in development than an early feasibility study, FDA would expect to see more nonclinical (or prior clinical) data in a traditional feasibility study IDE application.4 A traditional feasibility study does not necessarily ...
1. FDA grants iota Biosciences IDE approval for first-in-human early feasibility study with implantable bladder device. News release. Astellas Pharma Inc. October 10, 2024. Accessed October 15, 2024. https://newsroom.astellas.us/2024-10-10-FDA-Grants-iota-Biosciences-IDE-Approval-for-First-In...
First patient enrollment in MAGICAL-BTK IDE Study in the United States. 在美國食品和藥物管理局 (FDA) 最近獲得MagicTouch PTA的 IDE 批准後,這次成功招募病人,預示著 Concept Medical 在美國的周邊臨床試驗計劃正式開始。由於MagicTouch SCB在冠狀動脈疾病的 IDE 研究正在進行中,Concept Medical 目前正積極參與冠...
柏林--(美国商业资讯)--BIOTRONIK SE Co. & KG发布了治疗室颤(AF)的一种新技术TactiCath获得预上市核准(PMA)的两项关键里程碑:FDA的IDE (研究器械豁免)核准和TOCCASTAR (TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation)临床试验的首例患者入组。