Women's Health Weekly
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Breast Cancer
U.S. FDA 510(k) premarket approval issued for Ytterbium-169 radioactive source
February 17th, 2005
Implant Sciences Corporation (IMX) has received the approval of its 510(k) premarket notification from the U.S. Food and Drug Administration (FDA), which allows the company to proceed with the marketing of its new Ytterbium-169 radioactive source for the treatment of breast and other cancers. FDA approval represents a significant step in bringing the company's radioactive source to commercialization. The company, however, will take additional steps over the next 6 months before it can successfully commercialize this new product. These steps include registration of the radioactive source by the Massachusetts Radiation Control Program and receipt of a...
Source: Women's Health Weekly (2005-02-17)
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