Uromedica, Inc. Fighting for FDA Approval  
1/13/2012 8:34:26 AM

Minneapolis / St. Paul Business Journal by Katharine Grayson, Staff reporter

Tim Cook’s battle to get his firm’s medical technology approved for sale in the United States is once again in regulatory authorities’ court.

Cook is president and CEO of Uromedica Inc., a Plymouth-based firm that developed a pair of devices that treat urinary incontinence. The company is doing brisk business in Europe, where it’s had approval to sell products since 2002.

The U.S. market, however, has been off limits. The U.S. Food and Drug Administration rejected the company’s bid to sell its ACT device, which treats women, in 2010 — two years after the company submitted its application.