Radiation oncology and interventional cardiology firm Implant Sciences said it has received clearance of its 510(k) application from the U.S. Food and Drug Administration. The clearance allows the company to proceed with the marketing of its new ytterbium-169 radioactive source for the treatment of breast and other cancers.
Implant Sciences said it will take additional steps over the next six months before commercializing the product. These steps include registration of the radioactive source by the Massachusetts Radiation Control Program and receipt of a National Institute of Standards and Technology traceable calibration.
In addition, Implant Sciences intends to supply the new radiation source to several radiation oncologists for a pilot clinical evaluation, according to the Wakefield, MA-based company.
By AuntMinnie.com staff writers
January 27, 2005
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