Focal to market directly in North America
This article was originally published in Clinica
Executive Summary
Focal, the manufacturer of the FocalSeal surgical sealant line, has decided to market the product directly in the US and Canada, rather than employ a marketing partner as it does in Europe. FocalSeal is not yet approved in the US, although a PMA application for the use of FocalSeal-L (long-term absorbable) in lung surgery was granted expedited review by the FDA in April. The company recently submitted the final part of the application.