FDA grants 510(k) clearance to North American Scientific's low-dose breast brachytherapy product

By Lisa Kerner

Erie, Pa., April 25 - North American Scientific, Inc. said it received 510(k) clearance from the Food and Drug Administration to market the low-dose rate radiation treatment of its breast brachytherapy (internal radiation) product.

The company's product is designed to enhance accelerated partial breast irradiation treatment options, an estimated $500 million U.S. market, according to a news release.

North American Scientific's multi-channel catheter system allows for either low-dose therapy, using its ProsperaI-125 seeds, or high-dose rate treatments. The company said it plans to apply to the FDA for 510(k) clearance for the high-dose rate option later this summer.

Both the low-dose and high-dose designs are targeted for a November release.

Based in Chatsworth, Calif., North American Scientific provides radiation therapy products and services for cancer treatment.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.