OrthoLogic submits new data for improved efficacy claims on bone growth stimulator.
This article was originally published in The Gray Sheet
ORTHOLOGIC SUBMITS MORE DATA ON BONE GROWTH STIMULATOR CLAIMS of increased success rates and shorter healing times for its OrthoLogic 1000 bone growth stimulator, the company says. In an effort to address issues raised by FDA in a May 31 warning letter to the firm, OrthoLogic says it submitted data to the agency in July revising a premarket approval application supplement for increased efficacy and healing times for the device. The additional data includes patient registry data that meet the device's original PMA inclusion criteria.
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