Orthologic OL-1000
This article was originally published in The Gray Sheet
Executive Summary
Bone growth stimulator labeling change approved via premarket approval application supplement eliminates limitation for use in healing only non-union fractures that are at least nine months post-trauma. Under the revised labeling, "a fracture is considered non-union when the fracture site shows no visibly progressive signs of healing," the firm says in a June 18 release