Medical device manufacturer Imagyn Medical Technologies has received 510(k) clearance from the FDA to market its isosleeve pre-loaded needle delivery system for prostate brachytherapy. The product, meant for use in conjunction with the Irvine, CA-based company’s isostar Iodine-125 brachytherapy seeds, is shipped in a ready-to-use package.
The delivery system contains a digital record, with each order showing its loading pattern. In addition, the sleeve can be removed and re-inserted for a visual check, a feature Imagyn says is new to the brachytherapy field.
By AuntMinnie.com staff writersDecember 6, 2001
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Imagyn buys Intl. Isotopes brachytherapy assets, May 1, 2001
Theragenics adds deal with Imagyn, September 22, 2000
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