Uromedica, which develops urinary incontinence treatments, will find out in as soon as a few weeks if its medical device for men is ready for U.S. Food and Drug Administration approval application.The Minnesota medical device company submitted fresh data to the FDA that, if accepted, would be the basis for a premarket approval (PMA) application, CEO Tim Cook said. Uromedica sent the data, which included a clinical analysis of more than 120 men, to the FDA in November. The company hopes to hear back from the agency by the end of January.

GT Urological has raised $4.56 million from the sale of equity, according to documents filed with the Securities and Exchange Commission.

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 reactive it to prove to the Food and [...]

If the Food and Drug Administration has been too cozy with medical device companies in recent years, as some critics charge, Uromedica Inc. must have missed the memo.Since 2000, the Plymouth, Minn.-based company has been haggling with the FDA over its balloon device to treat urinary incontinence. Ten years and several clinical studies later, Uromedica [...]

“We’re not here to bash the FDA,” Mark DuVal, president of Minneapolis law firm DuVal & Associates, told a group of medical device executives and investors late Wednesday afternoon.Too late.The newly formed Minnesota Medical Device Alliance billed the gathering in the downtown Warehouse District as the first step to help save the Food and [...]