ForeCYTE Breast Aspirator regulatory update

Atossa said FDA declined to approve the company's 510(k) application for the ForeCYTE Breast Aspirator for use in the collection of nipple aspirate fluid for laboratory cytological testing. According to Atossa, FDA determined that ForeCYTE did not meet the criteria for substantial equivalence to its predicate device and provided guidance on additional performance data the company may provide in a new 510(k) application.

Atossa plans to conduct studies needed for a new application once it reaches an agreement with FDA on the studies the agency is seeking. In August, Atossa submitted information in response to a February request from FDA related to the 510(k) application, which included data from a single-arm clinical trial in adult women using ForeCYTE for the collection (see BioCentury, March 10 & Sept. 8). Atossa said it anticipates obtaining CE Mark approval for ForeCYTE in the next 30 days, with a launch in select European countries slated for 1Q15. Additionally, Atossa said it will prioritize the launch of an alternative approved breast aspirator, FullCYTE Breast Aspirator, in the U.S. Atossa acquired FullCYTE from Hologic Inc. (NASDAQ:HOLX, Bedford, Mass.) in 2012. ...