March 22, 2013 / 2:25 PM / 5 years ago

Medical device maker Cytori Therapeutics loses approval fight

WASHINGTON, March 22 (Reuters) - A U.S. appeals court ruled on Friday that the Food and Drug Administration (FDA) acted correctly when it denied fast-track approval of two stem cell-related medical devices made by Cytori Therapeutics Inc .

The FDA had reasonable evidence to find that the devices were not substantially equivalent to devices already on the market, according to the unanimous ruling from the U.S. Court of Appeals for the District of Columbia Circuit.

The FDA’s decision meant that Cytori had to conduct extensive clinical research as part of premarket approval.

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below