People have been shipping such systems since at least the mid 90s (e.g. CADe) but it's always been a bit of a difficult area from a regulatory point of view.
If you go back a couple decades, or really even only one depending on the panel, it was fair to describe the FDA as an organization that understood hardware but didn't really understand software. On top of this, a lot of their approach was focused on controlled, reproducible results. So anything probabilistic or even worse, continually learning, becomes difficult to frame.
The FDA guidance doc/ action plan (link is broken in article and on FDA site: it's here https://www.fda.gov/medical-devices/software-medical-device-...) is actually pretty encouraging, because they took community feedback from the original request for feedback (https://www.fda.gov/media/122535/download) and seem to have handle that process reasonably.
Many people I've talked to without direct experience seem to assume the 13485 process as a whole is needlessly bureaucratic, but in my experience it's mostly holding yourself to a higher engineering standard that some other industries, and works out ok. This willingness to engage with technologies can be frustratingly slow, but it's mostly reasonable.