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PaperclipPerfector  5d ago (text post)   2488 thread views

Small-Scale Question Sunday for June 21, 2026

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https://www.midjourney.com/medical/blogpost

It starts by stepping into a shallow pool of golden light. You then begin to descend into the water. Your body passes through a ring of underwater sensors, each acting like a dolphin, using its echolocation.

I'm a little confused as to how Midjourney is avoiding the FDA classifying their scanner as a medical device. Are they just hoping that the feds see "spa" and don't bother to look closely? It seems like squeezing this through the general wellness exception would be a stretch.

I am not an expert in law, but my guess would be that if it doesn't do anything medical, and it doesn't diagnose anything medical then it probably doesn't trip any medical laws. It takes pictures. It's just a very fancy way of taking pictures inside your body, but not in a potentially damaging way like an X-Ray that has to be used for medical purposes in order to justify the risks.

We’re starting by just giving you detailed body composition maps — and we’ll be submitting regular test results to the FDA for increased capabilities.

Seems like that's their understanding too. If they want the AI to actually look through the photos and make medical conclusions based on them they need FDA approval (which they are working on getting). But if it's literally just taking images and giving them to you then it's just a really high tech camera.

It's one of those things where the FDA can be incredibly overzealous on a whim. They have a lot of discretion. Midjourney needs to be very careful about what they say.

I suspect that the fact that they have deliberately left out features which they are currently going through FDA approval for is going to show enough deference to and stroke the ego of the FDA enough to keep them mollified for the time being. It's possible that if the FDA rejects their submission for AI diagnosis tools it might also retroactively restrict the whole thing, but I think it's more likely they allow the partial use because it validates their authority.

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