Re:IBM pitched Watson as a revolution in cancer care, but it...
by ska on Wednesday September 06, 2017 @03:26PM
(#15186412)
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.
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.