Dune Medical Devices, a healthcare product manufacturer based in Framingham, Massachusetts, is pursuing approval of its MarginProbe system with the United States Food and Drug Administration. This past summer, Dune Medical Devices received a 10-1 recommendation from an FDA panel. In the past week, the company also received an approval letter from the U.S.-based regulatory agency. This approval letter is the final step before the device receives full approval.
According to the FDA letter, the MarginProbe will be approved contingent on a final agreement with the company. The final agreement will be used to set up a traditional post-approval study of the system. Dune Medical Devices has stated that it will work diligently in the upcoming weeks to create an accurate, efficient study to speed up the path towards full market approval.
The MarginProbe system is designed to reduce the need for follow-up operations after a breast-conservation surgery. Through the use of imaging tools, the MarginProbe can determine the presence of cancerous or malignant tissue near the surface of excised tissue. According to a recent study, the MarginProbe may be able to reduce the need for re-excision by 50 percent. The MarginProbe system has already received CE Mark approval in the European Union.