NAS gets FDA 510(k) for low-dose breast brachytherapy

AuntMinnie.com staff writers

Apr 25, 2006

Radiation therapy firm North American Scientific (NAS) of Chatsworth, CA, has received 510(k) clearance from the U.S. Food and Drug Administration to market a low-dose-rate radiation treatment version of its breast brachytherapy product.

The product is designed to enhance current accelerated partial-breast irradiation (APBI) treatment options, an estimated $500 million U.S. market, according to NAS. The low-dose treatment uses the company's Prospera iodine-125 seeds delivered to the treatment site via a multichannel catheter.

The firm said it expects to file a second 510(k) application with the FDA to market a similar device for the high-dose-rate procedure.

NAS reported that it plans to launch both versions at the American Society for Therapeutic Radiology and Oncology (ASTRO) annual meeting in Philadelphia this November.

By AuntMinnie.com staff writers
April 26, 2006

Related Reading

NAS opens $4 million credit line, March 31, 2006

NAS launches breast brachytherapy initiative, March 21, 2006

NAS gets Nasdaq noncompliance notice, March 20, 2006

NAS cuts losses in Q1, March 10, 2006

NAS receives Chinese clearance for IGRT device, February 21, 2006

Copyright © 2006 AuntMinnie.com

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