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.
Interlace president and CEO Bill Gruber said the MyoSure system permits physicians to remove a fibroid roughly the size of a walnut in less than 10 minutes and minimizes the need for cervical dilation during the procedure.
In June, the company raised nearly $21 million in a Series C funding round to begin commercializing the device.