The FDA Advisory Panel voted (10 to one) in favor of Dune Medical Device's MarginProbe System for use in breast cancer surgery, as an adjunct to current standard methods of intraoperative surgical margin assessment.
Dune of Ceasarea Industrial Park, Israel, submitted a premarket application in April 2011 based on data from a 600-patient study, conducted primarily in the U.S. The MarginProbe System can allow for detection of cancer at or near the surface of excised tissue specimens during surgery for breast cancer, according to the company.
"We will work closely with the FDA to complete the approval process and intend to launch the MarginProbe System in the U.S. immediately thereafter," said Dune's CEO Dan Levangie in a news release.
The device is commercially available in Europe, but remains an investigational device in the U.S. The FDA usually takes the recommendations of the panels, but is not required to.