Uromedica said today it won a reimbursement code from the Centers for Medicaid and Medicare Services for its ProAct adjustable continence therapy for men, and that it launched the device in the US. The ProAct system has FDA approval and is indicated for treating adult men with stress incontinence from intrinsic sphincter deficiency of at […]
Uromedica
Frustrated by FDA, Uromedica attempts to innovate clinical trial
By Thomas Lee
Suppose you’re a woman suffering from urinary incontinence, a rather unpleasant feeling. A surgeon implants a balloon device, allowing you to pee or to pee less. But the company who makes the device now wants to turn off the device for a week or two and then reactivate it to prove to the Food & Drug Administration that it does indeed work.
Tough sell? Probably.
Uromedica’s 10-year PMA battle wears on at FDA
By Thomas Lee
If the Food & Drug Administration has been too cozy with medical device companies in recent years, as some critics charge, Uromedica Inc. must have been missed the memo.