Conformis Inc. said it withdrew its application to the FDA for a 510(k) the Itotal Hip implant due to the agency raising a number of questions about the product. The Bedford, Mass-based company said it was not able to address all the questions within the allowed review timeline and plans to submit a new application in the second half of this year. The company originally submitted an application for 510(k) clearance of Itotal Hip in the second half of last year. News of the withdrawal caused shares of Conformis (NASDAQ:CFMS) to take a tumble, trading down as much as 9.6 percent on Monday. Read More
