Uromedica

Potential of male urinary incontinence treatment in U.S. could be known by January

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.

By Chris Seper

Devices & Diagnostics

GT Urological raises nearly $5m for urinary incontinence device

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

By Thomas Lee

Exclusive

Improving the Healthcare Financial Experience to Help Care Flow

Zelis CEO Amanda Eisel shares her perspective on how the company is solving the problems of a fragmented health financial system to benefit all.

By Stephanie Baum

Policy

Stymied by the FDA, Uromedica tries to plot a way forward

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 […]

By Thomas Lee

News

Uromedica seeks light at the end of a (very long) FDA tunnel

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, […]

By Thomas Lee

Policy

Minnesota med tech on possible 510(k) overhaul: ‘We’re not gonna take it …’

“We’re not here to bash the FDA,” Mark DuVal, president ofÂ 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 […]

By Thomas Lee