IsoRay nets FDA OK on seeds

Medical isotope developer IsoRay Medical of Richland, WA, has received additional U.S. Food and Drug Administration (FDA) 510(k) clearance for its Proxcelan cesium-131 brachytherapy seeds.

The new clearance will allow the company to preload cesium-131 into flexible braided strands and surgical mesh, expanding the applications for treating prostate cancers that are beyond the scope of current products.

While the cesium-131 seeds themselves have been cleared for this indication since 2003, this FDA 510(k) clearance allows the seeds to be delivered in a new sterile format that can be implanted without additional seed loading by the facility.

IsoRay plans to use the product to treat lung, head and neck, and other organ tumors.

Related Reading

IsoRay sales drop, loss narrows, May 18, 2009

IsoRay expands into Canadian market, May 7, 2009

IsoRay, BrachySciences ink deal, February 18, 2009

IsoRay sales slip in fiscal Q2, February 17, 2009

IsoRay taps VP, November 24, 2008

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