Dune Medical Devices Inc. says it has won an expedited review from the U.S. Food and Drug Administration (FDA) for its experimental device designed to improve the accuracy of breast cancer tumor removal surgery.
The privately held, Framingham-based medical device company announced the FDA has accepted its application for pre-market approval for the so-called MarginProbe system, which detects cancerous tissue at the edge of tumors. The device enables doctors to make sure they have “clean margins” and have removed all of the cancerous tissue. The device aims to reduce the number of additional follow-up surgeries needed to excise cancerous tissue that was missed during the initial procedure. Currently, 30 percent of patients require follow-up surgery, according to the company.