ndforlife re: mammo...
first: there are 3 types of biomedical engineers...but before i list them, it would be good to differentiate how engineers are different than scientist, how? -- engineers are problem solvers to make things happen, they understand the science in the pragmatic sense...
- entrepreneurial (the rarest).
- research.
- clinical.
dean is first and foremost the first of these, therefore when he speaks of mammo, it's not to him (imo) a question of should we adapt the DViS, it's a matter of okay how do we go about to make this happen...
imho, this application would be the most scruntinized -- just by the existing rules/reguations on mammo (see somewhat what i mean below) -- of the three applications he has mentioned going forward after initial clearance... the other two being 1) adjunct to radiotherapy planning, and 2) an applicable application to weight bearing exams... of which the latter is most interesting to me because it would be a new thing, i'm not aware of any CT which can be used to conduct weight bearing examinations... and for all of these we are talking the CT feature of the DViS in my opinion. [by the way, in the world of plain films weight bearing x-rays are typically taken to evaluate the hips and/or knees and/or feet. of which these are ordered sorta frequently. if an apparatus existed to apply weight bearing exams in CT for these joints it would obviously be used for orthopedic surgery planning.]
back to mammo: as has been elluded to here last month the FDA meet to discuss [x-ray digital imagery procurement] mammo and then CAD (computed aided detection)...in mid november... see my post IHUB post number 5451 to get a take on the outcome of that per an auntminnie reporter.
such an indication of the DViS would need to have something set up to follow those recommendations or at least be somewhat in sync with them, etc... would need to meet primary/secondary endpoints i think...
therefore, it would be a bigger hurdle than indications/use for radiation therapy planning and/or a truly new CT application applied for weight bearing exams...
here's something to consider now though... while mammo is the term used to describe an x-ray exam... there are ultrasound indications for breast cancer detection... and, in 2007 i believe it was, the american cancer society came out recommending MRI of the breast cancer detection (sorta of a test to make a differential diagnosis) for women at high risk for cancer (familial history and interesting mammo/ultrasound images)... i'm not sure of the exact story behind MRI's evolution into that arena, but nevertheless, we now have that recommendation, afterall MRI is a detector used to examine any soft tissues by providing good contrast imagery of them...
if the DViS could somehow be adapted to provide an exam for this arena it would be at the level of the mammo, not ultrasound or MRI...
mammo requires softer x-rays and in CT mode the DViS would be of a greater advantage than the harder x-rays from most CTs...in fact, there was a study on the risks of breast cancer development associated with CTA (CT-angiograms of the heart), i don't recall the results...
i would image the DViS, if dean decides to pursue some application in this arena would be somewhat scaled...i dunno...like maybe take thinner slices, perhaps 32 slices...
there are strict and stringent regulations on mammo x-ray systems in order to ensure the performance of such systems, i.e., there are greater quality assurance requirements compared to other x-ray systems.
dean is well-aware of all this, as he has frequently mentioned (or touched on it) in cc's, and for which he went on to state in his reply to you in the most recent one...i.e., something about going down that path would muddy up the 510K and so he opted to pursue the most straight and generic indications (i'm very happy concerning the latter change to a more generic wording)...also, the latter being great for everyone here, and the medical community.
on that note: i'm not sure what he'll decide to eventually do...
this post is only merely to provide a little color on the topic...
least we not forget, the underbelly of all of this is the comments from some government committee with what became a highly controvesial issue in women's health -- of recommending guidelines which post pone initial mammo exams until up to 10 years later for women... for whatever motivation the committee had...
