Many FDA-approved AI medical devices are not trained on real patient data

The lack of "published" clinical validation studies implies neither that the AI developer performed no clinical validation nor that the FDA hasn't seen it. So, it is not clear if the problem is with the lack of clinical validation or the lack of reporting. For some reason the title exaggerates yet further (half of FDA-approved AI not "trained" on real patient data).

The FDA keeps a database of all adverse events reported by manufacturers or healthcare systems [1], so we can check in a few years if these AI medical devices are causing an uptick of complaints.

[1] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/s...

Why does this has to be so hard? I mean what if the regulators went the opposite approach: make ALL the data publicly available by anonymizing it.

What privacy concerns would anyone have if the whole data is completely anonymized? Wouldn't it create far more benefit by accelerating innovation in healthcare? I strongly believe the privacy concerns (which shouldn't exist after stripping out any PII) are outweighed by an order of magnitude by the upsides, which are literally saving millions of lives in the longer term.

But again, regulation, as always, cripple innovation, this time slowing down developments that would literally save lives. Great.

it's frustrating that the article uses the term "approve" which is specific to PMA devices (class III), whereas class II devices are "cleared" by the FDA.

- a medical device executive

They told me that FDA has nothing to do with actual product testing, e.g., human trials. What the "approval" guarantees is proper facilities and other second-order criteria.

I'm writing this comment in the hopes of learning that I have misunderstood something crucial here. Because if it is indeed the case that the companies themselves are the only ones vouching for drug safety, that old story about capitalism and incentives implies we're seriously fucked.