Staodyn
This article was originally published in The Gray Sheet
Executive Summary
Receives FDA permission to export its Dermapulse wound management system to The Netherlands. The company is setting up a European subsidiary, Staodyn BV, in The Netherlands which will market Dermapulse throughout the European Union ("The Gray Sheet" Nov. 29, p. 7). The firm also announces it will start shipping the device to Canada within 30 to 60 days, with European shipments "likely to start during the second half of 1994." Staodyn says it "continues to be optimistic" that FDA will approve its pending premarket approval application for Dermapulse, which it expects to be reviewed by an FDA panel this year