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FDA permits marketing of AI-based device to detect diabetes-related eye problems

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Re: FDA permits marketing of AI-based device to detect diabetes-related eye problems

#91

Post by arfar »

amelius wrote: post #23
rhacker wrote: post #6

Earlier quoted context omitted.

Seems like they are using this to get a proper referral to a specialist rather than using this as sole diagnosis. The code itself is probably 15 lines using Tensorflow or other framework I'm guessing, but could be wrong.

In that case, shouldn't the training data be open source? Seems like somebody got an unfair advantage here.

Oddly enough that's what they're aiming to claim a monopoly over.

Here's[1] a patent they have filed towards the system. Claims 1-18 and 20 are focused on the training of the neural network. Looks like Claims 1-18 are going to be granted soon largely in that form also from looking at PAIR[2].

[1] https://patents.google.com/patent/US20160292856A1/en?q=AI,ar... [2] https://portal.uspto.gov/pair/PublicPair

Re: FDA permits marketing of AI-based device to detect diabetes-related eye problems

#92

Post by ksolanki »

YeGoblynQueenne wrote: post #83
ksolanki wrote: post #75

Earlier quoted context omitted.

This is not completely correct. Sensitivity (87% in this case) is not same as accuracy, nor is specificity (89.5% in this case) same as true negative rate. Sensitivity generally gives an indication of safety of a medical device, and specificity gives a general indication of effectiveness.

The link changed since I posted my comment :) The original article on Verge reported "87% accuracy" and 90% what sounded like TNR. The new link points to an FDA page that makes it more likely that ".87" is actually sensitivity: Dx-DR was able to correctly identify the presence of more than mild diabetic retinopathy 87.4 percent of the time and was able to correctly identify those patients who did not have more than m…

Thanks for this analysis. The balance in real world is more like 20-80, ie 20% of typically screened patients would have referable retinopathy (screen positive).

Re: FDA permits marketing of AI-based device to detect diabetes-related eye problems

#93

Post by ksolanki »

return1 wrote: post #81
ksolanki wrote: post #74

As a founder of another company in this field, let me start by saying that this approval is a big deal. Kudos to IDx. This is the very first time FDA has approved a fully automated CADx (computer aided diagnosis) device. Eyenuk is also on it's way to an FDA approval and it is a lot of work conducting the prospective clinical trials. There are some misconceptions on the thread, so let me help clear them up. A screenin…

what is the screening like? is it possible there will be automated self-service 'kiosks' for that?

I believe the self-service kiosks would be very much feasible. There are two key components: (1) automated non-mydriatic (not requiring dilation of the pupil) retinal imaging and (2) automated grading of images using AI.

The technology is there but there would be more work needed for a self-service kiosk to be FDA approved. Another thing that is not clear is whether it is commercially a good idea at this time, given that only a single disease (diabetic retinopathy) is approved. I can see a future where one can use such kiosks to look for multiple conditions and assess risks for various diseases including cardio-vascular disease, neurodegenerative diseases, stroke, and hypertension.

Re: FDA permits marketing of AI-based device to detect diabetes-related eye problems

#94

Post by PeterisP »

j32fun wrote: post #41
bena wrote: post #39

Earlier quoted context omitted.

What's crazy is that if AI is better than doctors by some significant degree, what do we do when the doctor and AI disagree? Like if doctors are right 85% of the time, but the AI is 90%. I guess we treat it as another doctor? Like if we have 4 opinions that agree, we go with that one regardless of the source of those opinions (as long as they meet some minimum competence threshold).

That's an interesting thought. Currently, what happens is that if a diagnostic test comes back and it suggests something serious, say cancer, and the doctor does not pursue it, then the doctor would be liable if it did turn out to be cancer. So if a machine disagreed with a doctor, then I would assume that the doctor will grudgingly have to investigate further until there is enough evidence to rule out that diagnosis…

Doctors aren't liable for failing to predict the future or making imperfect diagnosis.

If a doctor reviews the available data, reasonably concludes that it shouldn't be pursued further, and it later does turn out to be cancer, then that by itself does not mean that the doctor is liable for anything. Malpractice requires actual culpable negligence, such as missing something obvious, not interpreting a questionable situation in a manner that turns out to be wrong. The existence of a second, contrary opinion doesn't change that.

Re: FDA permits marketing of AI-based device to detect diabetes-related eye problems

#95

Post by whitelionel »

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Re: FDA permits marketing of AI-based device to detect diabetes-related eye problems

#96

Post by whitelionel »

ksolanki wrote: post #74

As a founder of another company in this field, let me start by saying that this approval is a big deal. Kudos to IDx. This is the very first time FDA has approved a fully automated CADx (computer aided diagnosis) device. Eyenuk is also on it's way to an FDA approval and it is a lot of work conducting the prospective clinical trials. There are some misconceptions on the thread, so let me help clear them up. A screenin…

It is good to say the world is highly digital now, which leaves us with questions which we cant answer but with the help of some skilled professionals such as hackers and programmers,therefore for all hacking and programming services such as : Gmail, yahoomail, protonmail, electronic mail and other mail types hacking. Facebook, whatsapp, instagram, blackberry messenger,snapchat hacking. Iphone, icloud and mackbook hacking. CCTV hacking phone hacking and tracing [we can get text messages and redirect a copy of voice calls to a mail or phone,that would be a good one to stalk on your suspicious or cheating spouse] personal and office computer hacking school website hacking and grade changing/upgrading. Game and betting sites hacking[before and after game] bank details clearing criminal record clearing Bitcoin hacking Western Union hacking shopping website hacking for all other services not listed above contact us on snowdenhacks55 @ gmail . com be rest assured our works are ghostly done and no traces can be seen whatsoever, we have a reputation of over 10years and we are still building on that. contact us to put a quick smile on your face.

Re: FDA permits marketing of AI-based device to detect diabetes-related eye problems

#97

Post by Herodotus38 »

ska wrote: post #62
Herodotus38 wrote: post #28

I think the title is fine, but a lot of the comments are applying what the software does to medicine in general. What this software is used for is very specific, but also very useful in that it is a common medical problem. It is used only to help diagnose diabetic retinopathy (ie eye damage caused by diabetes). This is AI Vision software used to analyze a photograph of someone's retina to detect damage. In essence it…

PHI is a real barrier to your wish list, it's harder to get right than most people think and it is very very hard to get right in a distributed environment. And all the current advances in these general areas (voice recognition, transcription, semantic reasoning, etc.) are leaning heavily on distributed processing. It's definitely a well identified market and there are people working on it, but I haven't seen much pr…

The barrier is high enough that I heard that Microsoft is working on this with UW by using pretend patient encounters in an attempt to bypass PHI and get a database.

Re: FDA permits marketing of AI-based device to detect diabetes-related eye problems

#98

Post by pontus »

drta wrote: post #86
pontus wrote: post #64

Earlier quoted context omitted.

Keep in mind that the test wouldn't be administered on any randomly chosen diabetic patient but presumably rather on those who already exhibit some type of vision imparement consistent with the disease. As a result, the prior of 200k / 29M is not quite right and I'm guessing that the true prior is likely much higher.

>Keep in mind that the test wouldn't be administered on any randomly chosen diabetic patient but presumably rather on those who already exhibit some type of vision imparement consistent with the disease. Not true. The aim is to treat patients before they become symptomatic. Outcomes are much worse otherwise. 2min promo on Diabetic Eye Screening: https://www.youtube.com/watch?v=PK1Y-1BKFn0

I didn't know that. Thanks for pointing this out!
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