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OrthoLogic

This article was originally published in The Gray Sheet

Executive Summary

Receives an "approvable" letter from FDA for the OrthoLogic 1000 noninvasive bone growth stimulator for the treatment of nonunion fractures. "We are prepared to move forward immediately to market the OrthoLogic 1000 aggressively through our distributor network, as soon as final approval is received from the FDA," President and CEO Allan Weinstein said. FDA had requested additional information on OrthoLogic's premarket approval application for the device in June ("The Gray Sheet" June 28, p. 23)
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