FDA Approves AI-Powered Software To Detect Diabetic Retinopathy (engadget.com)

The U.S. Food and Drug Administration (FDA) has just approved an AI-powered device that can be used by non-specialists to detect diabetic retinopathy in adults with diabetes. Engadget reports: Diabetic retinopathy occurs when the high levels of blood sugar in the bloodstream cause damage to your retina's blood vessels. It's the most common cause of vision loss, according to the FDA. The approval comes for a device called IDx-DR, a software program that uses an AI algorithm to analyze images of the eye that can be taken in a regular doctor's office with a special camera, the Topcon NW400. The photos are then uploaded to a server that runs IDx-DR, which can then tell the doctor if there is a more than mild level of diabetic retinopathy present. If not, it will advise a re-screen in 12 months. The device and software can be used by health care providers who don't normally provide eye care services. The FDA warns that you shouldn't be screened with the device if you have had laser treatment, eye surgery or injections, as well as those with other conditions, like persistent vision loss, blurred vision, floaters, previously diagnosed macular edema and more.

Comments

No floaters?

[Anonymous Coward]

Doesn't everyone over 40 have those?

Re:No floaters?

[vtcodger]

"Doesn't everyone over 40 have those?"

No. Retinopathy is a problem for diabetics of all ages. It's just more common in us old folks because a lot of us develop problems with no or erratic production of insulin, or failure of insulin to work as well when we age. I assume that this will be a device that a doctor can use in a routine physical that'll replace an annual trip to the optometrist for an eye exam for diabetics. Sort of like routine testing for glaucoma or, for men, high BPA (high BPA correlates with prostate cancer).

There's really no cure for retinopathy, but there are treatments that can minimize the effect on vision.

I would guess that the device's utility will depend on cost and the percentages of false positives and false negatives. False positives probably aren't that big a deal because the next step would presumably be examination by an optometrist.

Re: No floaters?

[Anonymous Coward]

The gp meant that everyone over 40 has floaters. However, they committed the cardinal sin of treating the message subject as the first sentence of the message, so the confusion is on them.

AI

[Joce640k]

The FDA warns that you shouldn't be screened with the device if you have had laser treatment, eye surgery or injections, as well as those with other conditions, like persistent vision loss, blurred vision, floaters, previously diagnosed macular edema and more

Not very intelligent if it can't spot any of those, is it?

Re:AI

[Anonymous Coward]

As much as I hate AI-hype, even if the system can generally spot such conditions excluding patients that are likely to give inaccurate results is a basic precaution of medical testing. And the FDA is very conservative; I wouldn't put it past them to slap such a condition on any new diagnostic tool until the maker has demonstrated that it is sufficiently accurate on people with those conditions, which is considerably more difficult than people without them due to the larger populations alone.

Re:AI

[Anonymous Coward]

Camera details here:
http://www.topconmedical.com/products/trcnw400-literature.htm
Sorry they are a bunch of PDF files.
Sample images here:http://www.topconmedical.com/products/trcnw400-gallery.htm

Re: AI

[Anonymous Coward]

Exactly. Theranos 2.0!

Solve root cause instead

[religionofpeas]

Diabetic retinopathy occurs when the high levels of blood sugar in the bloodstream cause damage to your retina's blood vessels

An obvious way to fix the root cause is to switch to a low-carb diet, where you avoid high levels of blood sugar. Too bad there's more money to be made prescribing insulin and gadgets.

Re:Solve root cause instead

[Megol]

This is incredibly ignorant. Insulin is prescribed as the body needs it to function. In the old days before insulin the only "cure" was to have extremely low-carb diets which didn't work well in general.

Re:Solve root cause instead

[religionofpeas]

Insulin is needed for a few percent of the diabetics. And even then, most insulin dependents can benefit from having a low-carb diet in combination with much less insulin.

But I knew somebody would immediately come back with corner cases, ignoring the big picture of millions of people who can get better by fixing their diet.

Re:Solve root cause instead

[Anonymous Coward]

Actually recent studies show Sugar isn't a main factor anymore. It's a combination of things, including Genetic.

Re:Solve root cause instead

[TechyImmigrant]

This is incredibly ignorant. Insulin is prescribed as the body needs it to function. In the old days before insulin the only "cure" was to have extremely low-carb diets which didn't work well in general.

Nope. You appear to be ignorant. A low carb diet doesn't eliminate basal insulin. It fixes excess insulin. You are referring to type 1 diabetes which affects only a small number of people, whereas the majority of people in the USA are pre-diabetic and on the path to type 2 diabetes as indicated by their insulin response to glucose and most of them don't know.

Re:Solve root cause instead

[Anonymous Coward]

50 year Type 1 diabetic here. Frankly, you're not helping with the "ignorance" problem.

"Type 2" diabetes can be treated without insulin. It's the definition of Type 2. Most Type 2 diabetics have resistance to insulin: many of them have quite high levels of insulin in the blood stream. Over time, and with poor handling, it can progress to a form of Type 1, simply because the patient needs insulin in addition to their natural insulin in extreme forms of insulin resistance. It is infamously treatable with low carb diets, exercise to aid the insulin and control body weight, but those are often augmented with other medications. Type 2 is 20 times as common as Type 1, and also used to be called "adult onset". It also used to be less of an issue when people had less food available and did far more physical labor, though it certainly existed throughout history. (Hippocrates first published a diagnosis of it.)

The advantage of the "low carb" diet is that it reduces the spikes in blood sugar, which are tough to handle with insulin resistance. In early stages, it often triggers overproduction of insulin and hypoglycemia. As the disease progresses, the patient's insulin production can't keep up, and the blood sugar spikes despite the best efforts of their beta cells. Recovering from that can be an adventure, and it's the frequent or chronic high blood sugars that cause many of the consequences of diabetes, including damage to fine blood vessels, especially those in the retina, the kidneys, and the periphery (such as feet).

"Type 1" is insulin dependent. That is the clinical definition. The most common *pathology* or cause of Type 1 is an auto-immune problem that destroys insulin producing cells. This used to be called "juvenile onset" diabetes. This auto-immune problem can look like Type 2 in the early stages, but all insulin production is destroyed within a few years of onset. This auto-immune problem is much more profound, much more dangerous, and absolutely requires insulin. It's only 1 in 20 of the diabetics worldwide, but it is *vastly* more difficult and expensive to treat.

There are other causes for Type 1, including surgical removal of the pancreas, cystic fibrosis, and Klinefeldter's syndrome. Those don't completely eliminate insulin production, but they're still described as "Type 1".

Re:Solve root cause instead

[Anonymous Coward]

Those of us who's body doesn't produce any of the hormone needed to live (myself included) don't feel like corner cases. I agree that many cases of type 2 can be solved by diet. In fact, I have a really good insight into type 2 diabetes - when I'm running and biking a lot I can get by with 2 units of insulin per meal, and 12 of slow acting at nighttime, when I'm lazy and watch tv a lot, that goes up to 12 units per meal and about 30 units of slow insulin at bedtime. Type 2 people need to get more exercise and often their body would be able to use the amount of insulin their body produces to control their blood sugar level. It won't work for all type 2 diabetics though, but many.

Re:Solve root cause instead

[Anonymous Coward]

Insulin is needed for a few percent of the diabetics.

Yeah.. wrong. At least 3% of diabetics are insulin-dependent, and another at least 30% of diabetics use insulin. I guess you could call 1/3 "a few percent" or you could take your fat-shaming ignorance to make assumptions about the medical care of people you don't know, your choice. But in either instance you'd still be wrong.

Re:Solve root cause instead

[Anonymous Coward]

Wow, informative in spite of clear misunderstandings. "Excess insulin" can literally only mean one thing by any medical definition: hypoglycemia. Type 2 diabetics don't have "excess insulin" as evidenced by the fact that almost half of type 2 diabetics inject insulin. Moreover, a low-carb diet doesn't fix anything for any kind of diabetic because there are still sufficient carbohydrates to raise blood glucose levels above normal.

Or did you mean a theraeputic ketogenic diet where there's literally no carbohydrates? Ask the parents of a kid with pyruvate dehydrogenase complex deficiency whether people should willingly chose to eat like that just because there are fat shamers like you in the world.

Re:Solve root cause instead

[TechyImmigrant]

I avoided saying hypoglycemia or hyperglycemia because this is a lay audience.

Type 2 diabetics basal insulin level can be higher than a fit person's peak insulin level. Getting this down can be achieved through sufficiently low carbs and/or fasting. People have reversed their type 2 diabetes with various combinations of keto diets, low-carb diets and intermittent fasting.

I'm not diabetic, but I live on a keto diet that has dropped me 50 pounds and walked me back from pre-diabetes.

I'm certainly not a fat shamer. I was fat. I'm now fat-ish and getting smaller. I understand the mechanics leading to the insulin resistance viscous cycle and spent years studying the related lipid and hormonal biochemistry so I could solve my own problem and ended up on a keto diet as a result. A1c from 5.6 to 4.5. Liver from fatty to non fatty, glucose 140 to 80 and so on. I understand it is the circumstance of living with one's metabolism in a Western country with a Western diet that makes people fat due to excess fructose fattening the liver, wheat making their gut linings permeable, high carbs driving insulin resistance and stressing the pancreas and so on.

I don't have deep knowledge of pyruvate dehydrogenase complex deficiency, but I understand that it interrupts the citric acid cycle, so I presume a kid like that needs to run off beta-hydroxybutarate as best they can.

Re:Solve root cause instead

[TechyImmigrant]

Or beta-hydroxybutyrate. There's no spell checking on /.

Redundant?

[TheRaven64]

Is this actually useful? My optician takes a photo of my retina each year and compares it with the previous one when I have my sight tested. This comparison apparently provide a very high rate of detection of diabetes (before any other symptoms are visible). Do you really need a pattern-recognition system to do this? Is it actually better than an optician?

Re:Redundant?

[PeterGM]

It's probably not better but there are a lot of people who don't get their eyes checked as regularly as you do. A lot of people don't get their follow ups for example. I see this as another developing tool in the toolbox (used alongside current good methods) that will potentially allow for increased detection rates. It's worth having if it's helpful, passes a cost / benefit analysis, and doesn't suck.

All three of those things seem to be up in the air right now, but time will tell.

The fact that it can be operated by non-specialists also means that there's a greater scope for people to come in to contact with this testing. People could theoretically have this done at their GP instead of exclusively by their optician for example. I'm not entirely sure if opticians are generally so overbooked that people struggle to get appointments... I certainly doubt that actually... but even so it's another string to the bow.

Not a better string, not a replacement string, just another one.

Re:Redundant?

[tomhath]

The photo is worthless, either you have the symptoms or you don't. If the optometrist can't see them by looking into your eye you need to find a new optometrist.

Does your insurance cover that photo? I'm guessing not. I had an optometrist who tried the same scam on me, just an excuse to charge more for the exam to help pay for his next cruise.

Re:Redundant?

[nanospook]

So yearly at my company, they setup health screening by nurses (through a third party company). If they can use an AI driven device to look, you can then schedule an appointment knowing that it needs to be checked out.

Bitches gonna know bout my diabeetus

[Anonymous Coward]

The retinopathy check is not to diagnose diabetes. Itâ(TM)s to diagnose retinopathy.

Type 1 vs Type 2

[DrYak]

You're confusing diabetes types :

(I'm simplifying so you can get the gist of it, but my simplification isn't entirely wrong).

- Type 2 diabetes (most often occur in aged patients) :
the body is so overweight, that the fat tissue disturbs the hormonal balance and among other makes the body less sensitive to insulin.
(there are a couple of other rarer mechanism that could lead to the same end result).
The pancreas is still producing insulin as usual, but there are far less insulin receptors on cell surface, so glucose doesn't get absorbed (except in the brain).

Giving insulin, is a temporary measure (counter acting the lower reactivity of the body to the insulin), while changes in lifestyle is what is more likely to give long term results by lowering the overweightness and eventually stoping the disturbtion in the insulin system.
As an added bonus, it will also help against all the *others* distrubtions that obesity can cause (cholesterol, sex hormone distrubtion, mechanical stress on joints, etc.)

In a perfect world that what should be done. The problem is that the world isn't perfect and doesn't always work as you wish. It's *hard* to get people to change their lifestyle (again, type 2 shows usually at a later age, by then the bad lifestyle leading to obesity is a hard habit and not easy to fight), it might be possible (they might be in bad shape - due to other disease - and not able to exercice physically in adequate manner), it might not be sufficient (fixing the lifestyle and bringing the wright back to nromal will tremendously improve the situation, but not definitely cure it), or it might be in the few special cases where type 2 arises despite NO overweight patient.
In those case, keeping drugs is your fallback method.

- Type 1 diabetes (often occur at a younger age) :
is the body simply being unable to produce it's own insulin, but other wise functions normally
(most likely an auto-imune reaction caused to kill its own cell in the pancreas and kill most insulin production).

In this case, insulin IS the go to method. The body works as it should, its simply the pancreas that isn't producing insuline anymore, and you're simply replacing it with drugs and gadget.
The proper longterm solution would be to regrow the insulin-producing pancreatic cells, but the research isn't quite there yet (but advancing, so in the future my comment won't hold true anymore. Also as said abbove, this arises at a young age. Chances are high that these patients will grow up to an age where insulin cell regrow is a thing).

Meanwhile, redesigning the diet to be absolutely glucose free isn't an easy feat. (Again, it's not the insulin system working a bit less efficiently as in type 2, it the system being completely absent. you need to have a diet with nearly no glucose at all, as a few bodybuilders are doing). It's possible, some people are doing it, but it's not mainstream and not easy (and again, isn't the proper long-term solution anyway).
Keeping the drugs and the gadgets until you can get implanted with a "replacement pancreas" works better currently.

Now to go back to TFS,
in both case, prolonged exposure to increased glucose levels in the bloodstream can cause progressive damage to bloodvessel, which causes damage to multiple organs. The retina is one of the affected organs (as are kindeys, etc.), which requires regular monitoring.
This monitoring is normally done by specialists (ophthalmologist, not your family doctor) which might not be easily available in remote areas (small villages don't necessarily have one).
The device is a way to assist a non-specialist (your family doctor) to perform the exam.
Again , that something that needs to be monitored, even until the type 2 is cured by completely eliminating the root cause (obesity) for those few that managed completely recover once back to a healthier lifestyle.

Re:Type 1 vs Type 2

[Anonymous Coward]

I do not produce insulin,in the old days I would have been able to exist for a short time on a starvation diet and whiskey as that was the treatment my great Grandmother was given pre insulin. She survived for almost a year and died as basically a human skeleton.
I use the amount needed by my body to keep my blood sugar in control. You do know that the normal fuel sources source your body use down for energy are broken into glucose don't you? Which is what my body does not handle. No insulin I quickly climb into very high blood sugar levels again,Want to see what happens if I were to go carb free and only use fats as fuel and not use insulin? That's how they treated my Great Grandmother, no carbs, glasses of whiskey and a slow decline towards death. If you use more insulin you tend to put on weight, it's called feeding the insulin but most of us avoid that. I've tried going ultra low carb in the past, Dr. Bernstein a fellow T1 is a believer in it. While it does cut insulin usage way down it also means you are not real active, get out and be active and it does not work well. I had a number of extreme lows while I was trying his method and had to give up on it., I modified and stay lower carb now. I went very low while in a competition and went unconscious on a bicycle. Not a good thing to do at 20+ mph.

Re:Type 1 vs Type 2

[Anonymous Coward]

You have cause and effect backwards for many if not most of Type 2 diabetes and obesity. (It's OK, it's much easier to blame the victim.) While obesity aggravates Type 2 profoundly, the insulin resistance found in even slim Type 2 diabetics raises insulin levels. The insulin levels raise hunger, and any lethargy from excess blood glucose also tends to reduce exercise. Then the feedback loop of hunger, over-eating, and reluctance to exercise insidiously aggravates the problem, and untrained people blame the victim.

I'm Type 1, and I've watched people blaming innocent, newly diagnosed victims of Type 2 all my life.

Re:Type 1 vs Type 2

[Anonymous Coward]

This monitoring is normally done by specialists (ophthalmologist...

Not really. In fact, as a 20-year type 1 diabetic in the US, I can't get anybody other than an optometrist to handle the monitoring. You only get to see an opthamologist or retinologist once shit gets out of hand. To be clear, this is not for reimbursement reasons, this is that those professionals literally will not make you an appointment to check you out. More to the point, the "device" has existed for at least 15 years, it's the AI that allows some high-school biology course graduate to be good enough to take the picture.

As another point, repeating the usual "type 2 is insulin insensitivity caused by being overweight" does nothing to help any of these people understand that this is a much more complicated disease than that, one that can be "caused" by many many things. I think we owe it to anyone that has type 2 diabetes to stop assuming it's their fault by default.

Also: there are far less insulin receptors on cell surface

Are you serious? Have any medical literature to back up the idea that the trillions of cells in the human body all reduce these specific surface proteins in response to being overweight? Laughable.

Optician != Ophthalmologist

[DrYak]

Optician is not a medical doctor, he's the guy doing your glasses.
He can do some eye exams, he's even trained to recognize medical condition and to refer you to a specialist in those cases.

It's a useful spot that you can use to detect diseases.
But only people needing glasses are going to see an optician.

People with diabetes but no eyesight problem will never see one.

---

Ophthalmologist is the medical doctor that specializes in disease of the eye.
He's the one specially trained for diagnosing retina problem, including damage caused by diabetes
(and is the specialist to whom your optician will send you if he sees something abnormal during an eye exam)

Sadly, these types of exams require some specialized training. So you need an ophthalmologist, your family doctor isn't necessarily able to perform an exam.
  - comparing historical photos for evolution (as done by the optician) is a possible tool to help detect problems without a handy ophthalmologist
  - having the photos ran through an image detection system is another way to help detect problems by a non-specialist.

Sweet!

[bill.pev]

That should be easy to weaponize!

Who saw this coming?

[registrations_suck]

I need to work on my AI - it didn't predict this and so I never saw it coming.

AI not needed, old scans needed

[Anonymous Coward]

Any optical technician with an opthalmoscope can do a fast diagnosis of diabetic retinopathy. I've checked my own eyes with one. (Yes, I'm a diabetic: After 40 years, yes, I ahve some retinopathy.) What's harder to measure is *changes* in the degree of retinopathy, which is a very good sign of the quality of the control of diabetes. Other subtleties include "are those aneurysms near the macula" and "is that retina detaching" and "were those aneurysms there the last time we looked" and "sheesh, this diabetic also has cataracts, when do we want to do anything about that"?

Thanks for the post

[Okian Warrior]

Thanks for the great post - that's exactly what Shashdot should be about!

Type 1

[Anonymous Coward]

30.3M Americans have diabetes.
Only 1.25M have Type-1.
source: http://www.diabetes.org/diabet...

While having type 1 diabetes is critical to know for people with the disease, the vast majority of people with diabetes in western countries are type 2.
For T2 people, being on a lower-carb diet really is the cornerstone towards better health. This has been known for 100+ yrs.

Most doctors won't tell their clients strongly enough to change their lifestyle decisions for less carbs and moderate exercise. Reversing illness is NOT what the US health care system is about. They want lifetime drug users to force constant doctor visits and constant medications. How else will 20% of the US economy keep growing?

I don't like whiskey.

Jason Fung

[Brockmire]

I'd recommend to anyone to check out Dr Jason Fung. Any Doctor that calls out the bullshit doctors and "experts" that peddle false information to profit or advance their agenda gets my respect. Check out his blog at http://idmprogram.com/blog/. Well worth checking out.