As a non-invasive diagnostic equipment, let us say it is akin to a pregnancy test, or a creatine in urine test. That puts it in Class 1, and may be exempt from

As a non-invasive diagnostic equipment, let us say it is akin to a pregnancy test, or a creatine in urine test. That puts it in Class 1, and may be exempt from a lot of the hoops a medicine would go through. There are a little over 6,100 hospitals in the US at any given time. That means roughly $30,000 in cost to produce to provide every hospital with one, using the cheapest of cheapest parts. Presumably, you'd want higher end components and things like a shell casing to protect from spills, static, etc. maybe the cost is $120k. You could sell these for $100 each, and maybe make $5 million. That's a decent amount of money for a tiny business, but a pittance for even a small business that needs to pay salaries, lawyers, etc. In reality, they'd probably go for much more- let's say $10k each, plus $100 for each test strip. Still easily in range for the budget of most US hospitals. The real question is, if breast cancer is suspected, is this test any better than imaging using equipment the hospital already has? Can it detect all types, or the degree that it is progressing? I suspect the utility in a clinical setting is not high enough to really change clinical practices any.