FDAnews Device Daily Bulletin

FDA CLEARS BIOSPHERE MEDICAL'S NEXT GENERATION SEQUITOR STEERABLE GUIDEWIRE

June 13, 2006
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BioSphere Medical, Inc., a medical device company that pioneered the use of bioengineered microspheres to treat uterine fibroids, hypervascularized tumors and vascular malformations by a procedure called embolization, today announced that the U.S. Food and Drug Administration ("FDA") has cleared the BioSphere Medical Sequitor Steerable Guidewire ("Sequitor") Premarket Notification (510K) that allows Sequitor to be marketed in the United States. Sequitor is expected to begin shipping in the United States in July 2006.
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