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FDA Approves Software For iPhone-Based Vision Test 46

Posted by samzenpus
from the can-you-see-me-now? dept.
anderzole writes "The FDA recently gave clearance to Vital Art and Science Inc. (VAS) to market software which enables people with degenerative eye conditions such as macular degeneration and diabetic retinopathy to monitor their vision at home with their iPhone. The software, which is called myVisionTrack, isn't a replacement for regular visits to the doctor, but rather allows patients to keep tabs on their vision in between visits with eye care professionals. VAS notes that retinal diseases affect approximately 40 million individuals worldwide and 13 million in the United States. While treatments have been developed to deal with degenerative eye conditions, early diagnosis is of paramount importance — which is why the software is so important."
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FDA Approves Software For iPhone-Based Vision Test

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  • by Anonymous Coward

    The population of the USA makes up around 4.5% of the world population, but the VAS reckons the USA contains 32.5% of all retinal disease sufferers? What explains this?

    • One word: iPhones.
    • by slew (2918) on Friday April 12, 2013 @05:25AM (#43430719)

      Because if you write a press release to try and talk up investors, you only talk about the SAM (serviceable available market), not the TAM (total available market) for your products. Here's the original source [myvisiontrack.com]...

      Age-related macular degeneration (AMD), diabetic retinopathy (DR) and other retinal diseases afflict more than 40 million people in countries with advanced health care systems. Roughly 13 million people suffer from these diseases in the United States.

      For example, the EU has roughtly 8 million people that suffer from wet-AMD and DR. If you have any of these diseases and you are in a country w/o advanced health care systems, you are simply classified as blind (which is the eventual outcome for these diseases). This software (even if it were available and worked), will not help folks that are unfortunate enough to live in a country where appropriate treatments are unavailable.

      Sadly, with wet-AMD, there is no actual effective treatment today. There are some drugs known to slow the advance, of this disease, but not reverse it. With DR, there is some hope when reversing the diabetic aspect, but that is not really a great situation either.

      • Sadly, with wet-AMD, there is no actual effective treatment today. There are some drugs known to slow the advance, of this disease, but not reverse it.

        I beg to differ - the drugs currently on the market can stop the progression cold in many cases, not just slow it down. But the extent of permanent vision loss depends on how early the disease is detected and treatment started - wait too long, and scar tissue forms on the retina, which *is* irreversible.

        But these are "treatments", not "cures" - once diagnosed with such a disease, you will be a "customer for life" of some retina specialist. And the only drug that is actually FDA approved for this condition

  • Well, I hope a clone comes out sooner or later.

    • by ikaruga (2725453) on Friday April 12, 2013 @06:28AM (#43430849)

      Medical engineer here. Technically, anyone could make a clone easily. But it won't be FDA approved and therefore doctors won't be able to use them as diagnosis or treatment tools. Not even if the the original developer can port it. As a matter of fact it won't even be FDA approved if the app is run on any other iOS device that is not an iPhone 4S. FDA(and similar European and Japanese institutions) are extremely rigorous when it comes to approving medical products and even the smallest change to the software or hardware is enough to lose the "medical device" status. That is why they will sell the device pre-loaded with the app instead of using the appstore, so they can have a pre-determined OS version, no updates, no 3rd party apps or content. Also you need tons of testing(clinical trials and journal papers). Being cautions when it comes to health is very important but even I find FDA and friends a bit of excessive sometimes. This being an example, as I'm positive they could easily allow any other high-end phone. Heck, with all the respect, the Retina Display on the apple handheld devices (phones and PMPs) is actually is one of the "crappiest" smartphone displays nowadays(still good enough, but compared to the Galaxy S4 and Xperia Z and even phones from last year and a half, it sucks). Obviously, as another potential problem, they are at the mercy of Apple now. If Apple decide to stop selling the iPhone4S or decide that modding it and reselling it is against their rules, VAS has no choice but to get a new device and go through the FDA approval process all over again. Ideally they should develop their own system. It's more expensive, but it'll guarantee them a much higher degree of control.

      • Medical informatics researcher here. As a medical engineer you might want to do some research before labeling a screen "crappy". Just looking at the dpi doesn't do the job. http://www.displaymate.com/Smartphone_ShootOut_2.htm [displaymate.com]
        • by tlhIngan (30335)

          Just looking at the dpi doesn't do the job.

          With all those 400+dpi displays out there - are they actually... useful? Short of holding the phone to your nose or otherwise uncomfortably close (to make it hard to actually... use it) does one notice the difference between the 320-odd "retina" DPI vs. the 440 DPI these new 1080p screens offer?

          Or is it, as it seems, more mindless measurebating because it's a number that can be manipulated "more is better!". Like CPU GHz. Or megapixels.

          • With all those 400+dpi displays out there - are they actually... useful? Short of holding the phone to your nose or otherwise uncomfortably close (to make it hard to actually... use it) does one notice the difference between the 320-odd "retina" DPI vs. the 440 DPI these new 1080p screens offer?

            For the human eye it does not make sense to go above the ~320 DPI. It might make sense for Samsung to go to 440 DPI though because their Pentile displays only have two colors per pixel, with different combinations one besides each other (See e.g. here: http://en.wikipedia.org/wiki/PenTile_matrix_family [wikipedia.org]). But is a 440 DPI Pentile display better than a 320 DPI IPS LCD? Real tests like the ones over at displaymate.com might give an answer. Whether these in turn make any difference during daily use, who knows?

            A

  • So is it still the iPhone, or eyePhone now?

  • why not android? no need to hack to install your app that does not need to be in the app store.

    • To clear the FDA, it can't just be android. It has to be a specific model and Every model has to be separately certified.

    • why not android?

      Probably for the same reason it's only available for the iPhone 4s (read TFA) - the certification is probably tied to the hardware. (Most likely in this case, the screen.)

  • There was this nice app to cure acne and the damned FTC killed it. WTF does the FTC know about skin treatments anyway?

    http://news.consumerreports.org/money/2011/09/ftc-anti-ance-smart-phone-apps-marketers-fined-for-baseless-claims.html [consumerreports.org]

  • I have Idiosyncratic Central Serous Retinopathy, which leads to Macular Degeneration Among the challenges we face, is describing exactly what we see to the doctor for diagnostic use. For me that means I mock up my current visual state in Photoshop and bring it with me. But not everyone has these tools available to them to show vision distortion and areas of vision loss. When I went through the experience of PEM (Pigment Epithelial Detachment) that ended with my ICSR my vision changed nearly every day fo
  • ... to get your bio-digital signature voluntarily

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