Laws are changing to include "software medical devices" in health regulation. The FDA recently recognized this as a gap.

This isn't quite correct - FDA has always regulated software medical devices. It is true however that the FDA is looking a lot closer at software than they did in previous decades, and is releasing guidance (e.g. recently on cybersecurity) that signals intentions moving forward. They definitely have signaled that they don't believe they were focused enough on software.

It's important understand that FDA approval to market is always done in terms of indications for use. You don't approve a device full stop, you approve it (and evaluate it) in terms of the indications. Only in this context can you determine if you have a 510k path (i.e. short cut) or need a PMA (i.e. clinical trial). It is also important to realize that different panels in the FDA (i.e. the type of device you are making) have different evaluation criteria.

So "Watson" is unlikely to ever be cleared per se (it is a tech platform) but you are likely to see individual Watson enabled systems file 510ks for particular indications. If I recall correctly this has already happened.

Do you remember what it's already happened for? Do you know what devices they're equivalent to?

While I get the impression FDA and industry prefer 510ks as much as possible, personally I don't see how this is close enough to anything out there right now for that to pass the smell test.

My guess would be that some `Watson` equivalent stuff will be 510k'd in as part of an MRI, CT or DBT imaging system or a CAD tool working on these systems. I think it'd take a while though, I don't think the regulatory science is there yet for actually showing value.

Off the top of my head, I don't, but I'll have a look if I have a chance later.

There have been approved CAD systems separate from imaging systems since the 90s.

"Value" is a nebulous term. FDA looks specifically for "safety & efficacy", and the criterion for each are rather dependent on the intended use.

I can't tell if you're arguing that it is currently regulated, that it will be, or that it fits some platonic notion of 'medical treatment' and therefore should be (even if it's not beneficial).