The Framingham, Mass.-based gynecological device maker wins 510(k) approval for its MyoSure minimally invasive system to remove uterine fibroids.
Interlace Medical Inc. won 510(k) clearance from the Food & Drug Administration for its MyoSure fibroid removal system.
The Framingham, Mass.-based gynecological device maker said its hysteroscopic tissue removal system is a minimally invasive technique that allows for the removal of submucosal fibroids and polyps in a single, out-patient procedure. Submucosal fibroids are benign tumors that grow just beneath the endometrial lining of the uterus.
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