OrthoLogic promotion of bone growth stimulator for unapproved indications cited by FDA.
This article was originally published in The Gray Sheet
Executive Summary
ORTHOLOGIC BONE GROWTH STIMULATOR PROMOTIONAL CLAIMS, DEVICE MODIFICATIONS require submission of a premarket approval application supplement, FDA says in a May 31 warning letter to the firm. FDA says the company has promoted the OrthoLogic 1000 for treatment of fracture types beyond those approved by the agency and has made modifications to the device that require premarket approval.