EU Clears First Autonomous X-Ray-Analyzing AI

An artificial intelligence tool that reads chest X-rays without oversight from a radiologist got regulatory clearance in the European Union last week -- a first for a fully autonomous medical imaging AI, the company, called Oxipit, said in a statement. The Verge reports: The tool, called ChestLink, scans chest X-rays and automatically sends patient reports on those that it sees as totally healthy, with no abnormalities. Any images that the tool flags as having a potential problem are sent to a radiologist for review. Most X-rays in primary care don't have any problems, so automating the process for those scans could cut down on radiologists' workloads, the Oxipit said in informational materials.

The tech now has a CE mark certification in the EU, which signals that a device meets safety standards. The certification is similar to Food and Drug Administration (FDA) clearance in the United States, but they have slightly different metrics: a CE mark is less difficult to obtain, is quicker, and doesn't require as much evaluation as an FDA clearance. The FDA looks to see if a device is safe and effective and tends to ask for more information from device makers. Oxipit spokesperson Mantas Miksys told The Verge that the company plans to file with the FDA as well.

Oxipit said in a statement that ChestLink made zero "clinically relevant" errors during pilot programs at multiple locations. When it is introduced into a new setting, the company said there should first be an audit of existing imaging programs. Then, the tool should be used under supervision for a period of time before it starts working autonomously. The company said in a statement that it expects the first healthcare organizations to be using the autonomous tool by 2023.

ChestLink threads?

[smittyoneeach]

ChestLink threads?
Ask AI heads:
Who smoothly weds,
Avoids sick beds.
Burma Shave

Everyone of these articles always says

[rsilvergun]

It's there to cut down on workloads. It's not. Companies aren't going to let the radiologists sit around. They're going to fire the ones they don't need anymore.

Companies don't hire because they've got money they hire to meet demand. If automation produces the need for them to hire they're not going to cut their prices and they're by increased demand, they're just going to pocket the difference.

It's medical Care so they can charge damn near anything they want for it or you can just die. They know th

Re:

[gweihir]

Well, it is an additional step in automation. Nothing really wrong with that. That said, at least in the parts of Europe I know, radiologists all have long waiting times for non-emergencies. What this machine will do in the US is probably more like what you describe, no argument.

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[rsilvergun]

When I was a lad the solution to that problem was to train up more people who could do the job. Thanks to those kind of automation plus the ability to let people just go without healthcare or wait extended times it's allowed the rich and mega corporations to lobby for huge cuts to education that they otherwise couldn't get away with.

Having had more'n a few X-rays over the years ...

[mmell]

... and having 'em misread at least twice that I know of, I think I'll take an AI for the win here. They don't get bored, disgusted, tired, don't get unhappy about doctors treating them like the equipment, and (hopefully) they'll be in my insurance network.

Because, really, there's nothing like getting a call three days after your X-ray and hearing "Well, sir, we were wrong. Looks like your leg is broken, after all. Could you arrange to come back in so we can feel better about ourselves (too late to do anything about it, but we really want to bill, er, see you)."

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[Canberra1]

Agree, Automated 'filtering would be preferable. And I do mean filtering. There is automated assist skin cancer recognition also going on. Here is the problem. It is easy to do a chest x-ray, and identify the lungs or lung(singular) looking for cancers or fluid. But what if you see a cancer/white spot on the spine behind the lungs? It is not a mistake, but occasionally the lungs are good, but you can see something else. The article and the company really dont want to tell people they looking at a subset of

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[blahabl]

Whatever gave you the idea that it analyzes only lungs? No, it analyzes chest x-rays. And everything that can be found there, including that spinal cancer.

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[mmell]

My situation was found when a second radiologist reviewed my X-rays. That second review isn't under question here. I like the thought that an AI (which presumably isn't out golfing when I show up for my procedure) will be there to instantly provide that first read. I don't even know what this'll do to the incidence of problems being caught on review, but I bet it'll drop it to nearly zero - and, yes, I still want human eyes to check my film at some point.

Because if my situation with a broken leg didn't

Specific claim...

[fuzzyfuzzyfungus]

I wonder how much work is being done by the "clinically relevant" part of "zero clinically relevant errors", especially since the vendor themselves recommend first using it as a retrospective against already-classified images and then under supervision; both situations where any number of errors would fail to be clinically relevant.

I certainly wouldn't bet against machine vision in general; we know that it is fairly capable and we know that outperforming a human hardly requires infallibility; but people

CE mark?

[Luckyo]

Wait, are they talking about CE mark that is found on pretty much everything, including pseudoscientific shit like ear lights?

All that means is that manufacturer says it won't do something you don't expect, like blow up on you or release poison gas. I.e. that it conforms to basic health, safety, and environmental protection standards. It's neither a quality indicator nor certification stamp.

Like I mention above, pseudoscientific things like ear lights to cure winter depression in the north and magnetic bra

Re:

[Luckyo]

And here's the talking proof that Chinese can't even get CE mark. They have their own "China Export" mark that uses the same two symbols, but with a different distance between them to fake it.

Because Chinese crap actually does sometimes explode or release poison gas.

So they're stuck with the nonsense trolling instead. To pair with Russian orcs, they make the horde.

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[Luckyo]

Except for corporations from your nation. They often cannot. This is why we have China Export mark instead, for the failures.

Like you.

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[Vario]

CE means that the product can be sold on the European market because it complies with basic rules and regulations. And yes, the manufacturer or import company is responsible and an external certification is not required.

There are different rules though for "ear lights" and medical software. The ear lights are in the toy category, so it does not need to fulfill any function, so the regulatory bar is also very low. Anything that claims medical benefits has many more hoops to jump through. So if someone market

Re:

[Luckyo]

Ear light was in medical device category, as it came with a (now debunked) study that it helped alleviate winter depression.

Really?

[nospam007]

"The tech now has a CE mark certification in the EU, which signals that a device meets safety standards. The certification is similar to Food and Drug Administration (FDA) clearance in the United States, but they have slightly different metrics: a CE mark is less difficult to obtain, is quicker, and doesn't require as much evaluation as an FDA clearance. "

The CE mark is for toasters, earphones, hairdryers and radios, nothing to do with anything the FDA does, it just ensures you're not electrocuted when you turn the damn thing on.