Fusion Moving FAST To Test FloSeal Feasibility In 30-Patient IDE Study
This article was originally published in The Gray Sheet
Patient enrollment has begun at two sites in a randomized trial of the FloSeal Femoral Arteriotomy Sealing Technology (FAST) device, which is being developed by Fusion Medical for sealing femoral artery punctures created for diagnostic or therapeutic catheterization procedures.
You may also be interested in...
Fusion Medical sees a $35 mil. market opportunity for the cranial indication of the firm's Proceed hemostatic sealant, based on a projected per-kit price of $140 and more than 240,000 cranial procedures performed worldwide annually.
Regulatory review resource-intensive cell and gene therapy licensing applications are rolling toward US FDA along expedited pathways, while complete response letters and missed goal dates start to stack up under pandemic inspection constraints.