Radiation therapy products developer North American Scientific (NAS) said it has received 510(k) clearance from the U.S Food and Drug Administration to market the high-dose-rate radiation treatment design of ClearPath, a multicatheter breast brachytherapy device.
ClearPath is placed through a single incision and is designed to conform to the resection cavity following lumpectomy, allowing for more conformal radiation dose distribution during treatment. It also is intended to accommodate either high- or low-dose-rate treatments.
The Chatsworth, CA-based company received 510(k) clearance from the FDA to market the low-dose-rate version of the product, ClearPath CR, in April this year.
By AuntMinnie.com staff writers
November 14, 2006
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