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.