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Dr.
“We’ve done extensive studies on mammo[graphy], tomosynthesis, and breast CT… As we looked at the data, it was clear that when you have contrast-enhanced breast CT, it can virtually replace all other diagnostic examinations, including mammo[graphy], tomo[synthesis], ultrasound, and even MR (Magnetic Resonance Imaging).” – Dr.
Dr.
“When we started using contrast with the breast CT, the data that we saw, the images that we saw just blew you out of the water… there was just no comparison at all to mammography… I have seen, actually, cancers that are centimeters in size, so walnut-sized cancers that you absolutely have no idea exists in that breast when you look at it with either a traditional mammogram or tomosynthesis images. You take that same patient with that same walnut-sized cancer, and you do a breast CT with contrast, and it lights up like a lightbulb that you can see from across the room, and there is no doubt in anyone's mind that that is something that needs to be pursued, biopsied so that the patient can move on and get her treatment." – Dr.
Dr.
“Medical imaging devices go through a special process at the FDA… the imaging device is only as good as it helps the radiologist make an accurate decision, and so what you have to demonstrate in order to get through the FDA is that your imaging device will lead to greater diagnostic accuracy in radiologists… I have great hopes for the breast CT device, and I believe it is capitalizing on something that will be very useful and very beneficial to the women who undergo it. But the beauty of these studies is that it really doesn't matter what my hopes and dreams are. The study is designed to demonstrate it, or not." – Dr.
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