Rochester Medical's FemSoft to begin clinical trials:
This article was originally published in Clinica
Rochester Medical has received FDA approval to begin US clinical trials of FemSoft, its urethral insert for female stress incontinence. The studies will be conducted over the next few months and will involve over 100 patients. The company, which is based in Stewartville, Minnesota, expects to submit a PMA to the FDA next year. FemSoft is a soft, fluid-filled insert that assists weakened muscles and requires no inflation, deflation, syringes or valving mechanisms.
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