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Print Edition StoriesTuesday, September 16, 2008
Intact gets FDA clearance for lesion extractor
By Mass High Tech Staff
Intact Medical Corp., a developer of minimally invasive systems that diagnose and remove breast lesions, has received U.S. Food and Drug Administration 510k clearance for its Excise XL.
The Excise XL, a larger wand than the company currently has approved by the FDA, works with the Intact Breast Lesion Excision System by removing the breast tissue in question through a small incision in the breast. The larger wand can extract larger tissue samples or potentially remove the lesion entirely through an outpatient procedure. The procedure has the potential to eliminate surgery, company officials report.
Privately-held Intact Medical sells vacuum-assisted systems designed to extract intact specimens of suspicious tissue in the breast. The market for such products is crowded with competitors such as medical technology giant Johnson & Johnson, of New Brunswick, N.J.; Bedford-based Hologic Inc.; and California’s SenoRx Inc., according to a July 2007 Mass High Tech report.
Based in Natick, Intact Medical was founded in 1998.
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