Regulatory (medical device) approval?

[e-pet]

Out of curiosity, has any company been able to get any kind of regulatory approval (US, EU, doesn't matter) for an AI-based medical device trained in a federated setup? Has anyone tried this? Is it at all possible given current regulations? Are there any useful discussions / whitepapers / guidelines or whatever on this subject?

[chesterxgchen]

This question might be better ask in https://developer.nvidia.com/holoscan-sdk, which more related to the medical devices