2005-06-28
FDA recommends approval of STAN in the USA
FDA advisory panel meeting unanimously recommends approval of STAN™ in the USA
On June 23 the team from Neoventa together with the American investigators in the STAN application multi-centre study presented their case in front of the FDA expert panel in Washington. The panel unanimously recommended FDA to approve STAN for use in the USA.
- This type of approval places extremely high demands on a company to show product safety, efficacy and useability which is the reason why it is so seldom that new device of this type are approved by the FDA. We are very happy with the result, Simon Grant commented after the meeting. We will now work with the FDA to finalize the approval, hopefully by the end if this year.
Enclosed are the Swedish and the US version of the press release sent out on June 28, 2005.
Back