A device designed to help breast surgeons achieve cancer-free margins during lumpectomy surgery appears to be doing well in Germany where it is approved under CE mark. A study expected to be published in an upcoming issue of The Breast journal describes the use of Dune Medical Devices' (Framingham, Massachusetts) MarginProbe system as an adjunct to the standard of care in lumpectomy surgeries of women with early stage ductal carcinoma in situ of the breast.

As mentioned in a posting earlier this week, my wife and I were out for dinner recently and made the acquaintance of some opinions about FDA and the industries it regulates. Opinions about FDA ranged from awful to terrible, and doctors and industry fared no better. It seems a lot of people think user fees conscript FDA, and some see the agency, industry and physicians as some sort of malevolent troika that would have made the Kremlin of Leonid Brezhnev proud. Maybe I'm too close to it...