相关临床试验
11
0 进行中
药物批准
35
批准总数
监管机构
2
监管机构数
成立时间
N/A
已完成
10
90.9%
终止
1
9.1%
- Azenta, Inc. has appointed Board member Dr. Martin Madaus as interim President and CEO following the resignation of John Marotta as executive officer and director. - The Board has retained Heidrick & Struggles to lead a search for a permanent CEO while reaffirming fourth quarter fiscal 2026 total revenue guidance. - Fourth quarter fiscal 2026 adjusted EBITDA will be impacted by a one-time consulting expense of approximately $3 million, excluding which the Company would reaffirm adjusted EBITDA. - Dr. Madaus brings more than 30 years of diagnostics and life science tools leadership experience, including prior CEO roles at Millipore, Ortho-Clinical Diagnostics, and Roche Diagnostics North America.
- Haemonetics Corporation received FDA approval to expand labeling for the VASCADE MVP XL venous vascular closure system to include procedures using larger 10-14F inner diameter and up to 17F outer diameter procedural sheaths. - The approval enables use of the device with market-leading pulsed field ablation and left atrial appendage closure technologies for treating atrial fibrillation patients. - Clinical evidence from the AMBULATE EXPAND trial demonstrated 0% major and minor access site closure-related complications with a median time to ambulation of 2.4 hours in 77 patients. - The VASCADE MVP XL system is now the only extravascular venous closure system clinically proven in electrophysiology procedures using up to 17F outer diameter procedural sheaths.
- Haemonetics will acquire Ireland-based Vivasure Medical for €100 million upfront, with potential additional payments of €85 million based on sales milestones. - The acquisition brings Vivasure's PerQSeal Elite biosorbable patch system, which received CE mark approval for venous closure and has a pending FDA premarket approval application. - The deal strengthens Haemonetics' position in the $300 million large-bore closure market, particularly for structural heart procedures like transcatheter aortic valve replacement. - Vivasure's technology complements Haemonetics' existing vascular closure devices and expands capabilities for fast-growing endovascular procedures.
- Vivasure Medical has received European CE mark approval for PerQseal Elite, the first fully absorbable, sutureless closure system designed specifically for large-bore cardiovascular procedures. - The innovative device aims to improve procedural efficiency and patient outcomes in structural heart interventions like TAVR and EVAR, with planned launch in select European markets this summer. - Unlike current closure methods, PerQseal Elite requires no pre-procedure steps and leaves no foreign materials behind, potentially reducing complications associated with traditional closure techniques.
