
FDA permits marketing of AI algorithm for detecting wrist fractures - gk1
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608833.htm
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oliveshell
Interesting! I hope the tech works and can reduce potential suffering from
mis-read x-rays.

My brother fractured his scaphoid bone during a high school lacrosse game, and
the doctor who x-rayed his wrist did not detect it.

He continued living an active life with a broken wrist (he has a high pain
tolerance) for several months before the worsening pain sent him to an
orthopedic specialist.

Being unaware of the fracture, he had done quite a lot of damage to the bones
in his wrist, which wound up needing multiple surgeries and nearly 18 months
(!) in a cast to fully heal. He also permanenly lost a bit of that wrist’s
range of motion.

I welcome any tool that helps doctors not miss this sort of thing!

~~~
mnort
nothing is permanent

~~~
oliveshell
You may be technically correct, but what’s the point of this comment?

For as long as he is alive, he will have less range of motion in his right
wrist than his left, barring advances in nanotechnology bone reconstruction or
something.

Millions of years from now, when his body has broken down into petrochemicals,
I suppose that yes, his wrist will then have a greater range of motion then it
does now.

But that’s hardly relevant.

~~~
mnort
> For as long as he is alive, he will have less range of motion in his right
> wrist than his left, barring advances in nanotechnology bone reconstruction
> or something.

If that is his attitude - and the attitude of everyone around him - then that
will likely be the case.

In 'reality' \- whatever that means to you - plenty of folks have demonstrated
that the body is malleable.

With work, ROM is restorable.

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DoingIsLearning
Does this mean that from now on, anyone wanting to file some flavour of AI
classifier for medical diagnosis, can just file a 510k because there is a
precedent?

~~~
sriram_sun
Some more detail (from
[https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidan...](https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm)):
What is Substantial Equivalence

A 510(k) requires demonstration of substantial equivalence to another legally
U.S. marketed device. Substantial equivalence means that the new device is at
least as safe and effective as the predicate.

A device is substantially equivalent if, in comparison to a predicate it:

has the same intended use as the predicate; and has the same technological
characteristics as the predicate; or has the same intended use as the
predicate; and has different technological characteristics and does not raise
different questions of safety and effectiveness; and the information submitted
to FDA demonstrates that the device is at least as safe and effective as the
legally marketed device. A claim of substantial equivalence does not mean the
new and predicate devices must be identical. Substantial equivalence is
established with respect to intended use, design, energy used or delivered,
materials, chemical composition, manufacturing process, performance, safety,
effectiveness, labeling, biocompatibility, standards, and other
characteristics, as applicable.

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dmead
As someone who has had to deal with a hard to read break in an x-ray this is
great news.

Had the ER docs had this available I wouldn't have had to sit in agonizing
pain and uncertainty for a day before getting into see a surgeon.

It wasn't wrist related, but it seems like the application of this to other
stuff is not far off.

Very good news

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dang
Url changed from [https://interestingengineering.com/fda-approves-ai-tool-
that...](https://interestingengineering.com/fda-approves-ai-tool-that-can-
detect-wrist-fractures), which unless I'm missing something is cribbed
entirely from this press release.

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kevin_b_er
And in another 5-10 years insurance might approve it. Until then it'll
probably be a cash price of anywhere from $400-$4000 like the cost of an MRI.

~~~
EpicEng
>And in another 5-10 years insurance might approve it

Not sure why you think that, but I work in a similar field and I promise you
you're wrong.

