Orthologic 1000 bone growth stimulator improved efficacy claim approved by FDA.
This article was originally published in The Gray Sheet
Executive Summary
ORTHOLOGIC BONE GROWTH STIMULATOR IMPROVED EFFICACY CLAIM has gained FDA approval, the company announced Jan. 6. The agency okayed the Phoenix, Arizona-based firm's premarket approval application supplement claiming a 72.3% success rate for its Orthologic 1000 device in healing nonunion fractures that are at least nine months post-trauma.