NAS gets FDA go-ahead for low-dose breast brachytherapy product
Chatsworth, California-based North American Scientific, a specialist developer of innovative radiation therapy products for the treatment of cancer, says it has received 510k clearance from the Food and Drug Administration to market its low-dose radiation brachytherapy treatment. The approval marks a significant milestone in the group's Breast Brachytherapy Program, which it announced in March of this year. The firm estimates that the product, which is designed to enhance current partial breast irradiation treatment, has a potential US market of $500.0 million per year.
The company says that it will launch the product, and a similar high-dose version for which it intends to complete a separate 510k filing, at the 48th annual meeting of the American Society of Therapeutic Radiology and Oncology, in November.
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