Integra launches first synthetic skin product in U.S. following March 1 FDA approval.
This article was originally published in The Gray Sheet
Executive Summary
INTEGRA ARTIFICIAL SKIN SHIPMENTS TO BEGIN AFTER CLINICIAN TRAINING on use of the device, which is slated to begin in the next few weeks. FDA made physician training one of two conditions in its March 1 approval of a premarket approval application for the dermal regeneration template product. Training will consist of a one to two day session to be conducted by clinicians at multiple regional centers, according to the firm.