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Reimbursement / Regulatory

CarboFix Gains FDA Clearance for Pedicle Screw -

CarboFix Orthopedics received FDA 510(k) clearance to market the CarboClear® Carbon Fiber Pedicle Screw to treat oncological patients. CarboClear is intended to stabilize the spinal column in the absence of fusion for a limited time period in patients with advanced-stage in the thoracic and lumbar spine. Reported benefits of CarboClear include no backscattering, which allows the use of radiation therapy without harming the healthy surrounding tissue; minimal attenuation of External Beam Radiation, allowing radiation to pass through the implant with almost no reduction in the radiation dose level; and no artifact in CT. (CarboFix Orthopedics Ltd., 7/26/18)