In Brief: Rochester Medical
This article was originally published in The Gray Sheet
Executive Summary
Rochester Medical: Receives investigational device exemption from FDA to commence clinicals of its FemSoft insert for management of female stress incontinence. The single-use device, which consists of a soft silicone membrane sleeve filled with mineral oil, would be inserted into the urethra to block the flow of urine using a disposable stylette applicator, the firm explains. The insert would be removed for voiding by pulling a silicone tab attached to the device. Submission of a premarket approval application is anticipated in early 1998. If approved, the device would compete with UroMed's Reliance insert for female stress incontinence, which gained FDA approval on Aug. 21...