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Medical Imaging News


Medical Imaging News

January 24, 2007


REGULATION UPDATE

North American Scientific’s ClearPath Receives FDA Approval

North American Scientific Inc recently received 510(k) clearance from the FDA to market the high-dose rate radiation treatment version of ClearPath HDR, a brachytherapy product.

ClearPath features a multi-channel catheter system, which is inserted through a single incision. It is designed to allow for either low-dose therapy, using the company's existing Prospera I-125 seeds, or high-dose rate treatments.

Both systems offer greater flexibility in treatment planning and dose optimization to the target region while minimizing exposure to nearby healthy tissue, according to the company.

North American Scientific received 510(k) clearance from the FDA to market the low-dose rate system, ClearPath CR, in April, 2006.

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