Dune Medical Devices Ltd.'s Breast Cancer Device Gets a Date With the FDA
Published: Apr 06, 2012
The FDA's general & plastic surgery devices advisory panel is slated to convene June 21 for a hearing on Dune Medical's MarginProbe breast cancer diagnosis tool. Dune Medical Devices has a date with the FDA to review its pre-market approval application for the MarginProbe breast cancer detection device. The watchdog agency's general & plastic surgery devices advisory panel scheduled a hearing for June 21 to review the PMA data for the device, which uses electromagnetic waves to characterize human tissue in real time and "provides intra-operative information on the malignancy of the surface of the ex vivo lumpectomy specimen," according to the FDA.