Interesting but many issues which have been listed here are valid. This is my take on the largest of them.

Preventive testing is not always positive. False negatives creates a false sense of security and false positives drives unnecessary medical procedures. For example, what if this instrument sees "something" and a doctor then follows up with a biopsy, x-ray or explorative surgery. These will all have negative side effects. There has even been a debate of if mammography is a net positive. I think it might be but I'm just saying that even such a thing is debatable. The question is not only if the these early tests find anything, its also a question of whether detecting it early changes the prognosis. Maybe its untreatable anyway? Or maybe it would still be treatable if detected later? And then comes the cost of course, is it economical to do these scans on a population level relative to the alternative cost.

Building medical systems is not for the faint of heart. I was part of a startup building a Micro CT system with the long term goal of using it to detect tumors in biopsies live during surgery (1 um resolution for cm-sized samples) without waiting a week for the normal analysis. We also started with non-medical instrument (general research) and we never got to the medical instrument before we ran out of money (we engineers were too bad at sales). But we did study up on the (European) standards quite a bit. They are not crazy in any way. Its simply that you follow good engineering practice BUT it is hard to move from building a non-medical system to medical system after the fact. The standard is a process standard so it basically says "You should have followed this process when you designed your product". And you need be real careful setting your Intended Use and showing that you have Verified and Validated that your system can be used for the intended use. So most likely they need to build one product now (Body Composition Analysis), use that for research and then set up their Quality Management System before they rebuild everything from requirements to risk analysis to test plans to hardware to software. 10 years is probably on the low side for this and quite the cost.