>>>>NEWS!! Nasdaq:FMRX FDA Approval!!
FemRx secures FDA approval for Soprano
SUNNYVALE, Calif., May 13 (Reuters) - FemRx Inc. said Wednesday it has received 510k clearance from the U.S. Food and Drug Administration for its Soprano cryotherapy system.
The company said in a statement the Soprano system can be marketed for the surgical ablation of tissue by the application of extreme cold in the areas of dermatology, general surgery, neurosurgery, thoracic surgery, ear, nose and throat treatments, gynecology, oncology, proctology and urology.
FemRx said it has agreed not to market the device for abnormal uterine bleeding treatment until pre-market approval is received from the FDA.
Soprano, a surgical cryo-ablation system, is used during cryo-ablative reduction of menstruation, a procedure performed on women who are suffering from abnormal uterine bleeding and who wish to alleviate symptoms without undergoing a hysterectomy.
About two million women see doctors about this problem every year. |
