At present Hologic has FDA approval for the 2D machine and with an FDA approval most devices could be upgraded to the 3D capability. It’s a matter of a software upgrade, so the expertise of the FDA with programming and the assurance that the bugs are out is essential. Radiation safety is upmost at the top of the list for safety as we read all the horrible over exposure stories in the news that killed people, the big stuff at Cedar Sinai. That was different machine and process but all devices that work with radiation need the same assurance.
A year ago the FDA gave clearance to one of their other products called a MammoSite device which treats specific targeted areas with balloon radiation therapy. With this type of treatment a patient needs to be in good health and optimum results are for those that have not entered their senior years yet.
If you look at the Hologic website there’s tons of imaging products to look at and one thing that concerns me as a patient, will adequate training and use be available for all? I know exactly how this goes with software as I wrote enough of it and today we are seeing stories in healthcare and other areas where the software has issues. Hologic is a public company and on their website is pretty proud of the Nasdaq recognition they have received and they have to sell a lot of machines to keep investors rolling in.
They have a lot money invested and within the last few days we are now starting to see stories such as this one that are quoting studies that Mammograms are not effective in 90% of Breast Cancer screenings. Of course the jury is still out there too with coming up with decent guidelines for screening. It used to be 40 and now the guidelines are to begin screening at 50. This to me has ringing's of the Women’s Health Initiative where age makes a difference and instead of an annual screen once a woman has reached 70-75, cut these screenings back to every other year.
Certainly there are cases where a screening is suggested and should be done outside these parameters, but we are getting the point to where we have more accurate scanning devices and the earlier caught the better, plus it gets more expensive too. We do need some work on guidelines here I think. Down the road I wonder how some of these companies will be able to stay around if the cost becomes to excessive. BD
Hologic Inc.’s three-dimensional mammogram device is safe and improves breast-cancer detection when used in combination with conventional mammography, a U.S. panel said.
The machine is effective enough at finding tumors to justify the additional radiation exposure, outside advisers to the Food and Drug Administration said in a 12-0 vote today in Gaithersburg, Maryland. One panel member abstained from voting. While the FDA usually follows its panels’ recommendations, it isn’t required to do so.
The device, Selenia Dimensions 3D, is designed to find soft-tissue tumors that overlapping tissue can mask in two- dimensional images, the Bedford, Massachusetts-based company told the FDA in documents released Sept. 22. The product, already sold in Europe, Asia, South America and Australia, is intended for use with two-dimensional screening that detects calcium deposits, which can be malignant. Selenia was approved by the FDA in 2008 as a two-dimensional device and can be upgraded for both types of mammography if the agency clears the 3D technology.