Focal Seals FDA Panel Approval Recommendation For Lung Surgery Sealant
This article was originally published in The Gray Sheet
Executive Summary
Focal, Inc. should include a warning in labeling for FocalSeal-L synthetic lung surgery sealant that higher risks of infection or empyema may be associated with use of the product, FDA's General and Plastic Surgery Devices Advisory Panel recommended at a May 8 meeting in Gaithersburg, Maryland.