Dune Medical receives pre-market approval for breast cancer device
May 19, 2011
Dune Medical Devices Inc., a company in Framingham, Massachusetts, has received FDA approval for an expedited pre-market process for the MarginProbe device. MarginProbe is designed to find tissues with cancer that reside at the margins of tumors.
The company provided findings from the 12th Annual Meeting of the American Society of Breast Surgeons as part of its application for expedited FDA approval.
"Our mission is to develop a range of applications that allow physicians to detect cancer in targeted tissue in real time, and react immediately. This milestone with MarginProbe brings us one step closer to providing surgeons with an intraoperative technology that detects microscopically positive margins in patients undergoing surgery for breast cancer," said Bill Densel, the CEO of Dune Medical.
Breast cancer is diagnosed in more than 200,000 new female patients each year, according to the American Cancer Society. All women over the age of 40 should receive yearly mammograms, while younger women should perform self breast exams as well as have regular clinical exams.