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

"226 of 521 FDA-approved medical devices, or approximately 43%, lacked published clinical validation 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).

In the spirit of the authors' point of sharing one's supporting evidence, could you please share the data and code for scraping the list of devices from the FDA website? :)

Not a surprise. I worked on a ‘AI’ health insurance product for several years and even getting access to data was a struggle.

What's missing here is the risk of the medical device not performing as expected on real patients. These risks are usually mitigated reasonably by medical device manufacturers and designers such that it doesn't matter that "AI medical devices" are 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...

Maybe we could have an option to be a data-donor as opposed to only having the option to donate your organs for the purpose of science.

Huge problem is data protections in the USA that do not allow for easy sharing of patient data for these purposes. The liability is huge and the upside is very little. Furthermore, if it's a college-affiliated hospital, that data is not going anywhere except to the internal teams within the college.

Don't want to go too off-topic but:

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.

As a gastroenterologist I have used Medtronic GI Genius AI to do colonoscopies for the past 8 months. It is mildly helpful but has way too many false positive alarms for "polyps" that are not polyps. It needs better training in the real world.

How can anyone except big incumbents who are immune to competition get access to data? I feel this is an unfortunate situation where the opportunity to be an innovator is locked away. Some of the reasons are good but it’s not a great outcome for us all.

another confounding problem is how the FDA classifies and approves devices for clearance. most regulatory strategies have the company strive to find a predicate and prove they are substantially equivalent (SESE), which generally means a class II device, which does NOT require clinical data for clearance.

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

As long as these are diagnostic aids, not treatments like a pacemaker or medication, I don't see this as so concerning.

god save us.. hope they didn't use omniverse replicator.

Had a chat with a pharmaceutical company whistleblower recently.

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.

Elizabeth Holmes (in coarse voice): “Hold my beer”