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FDA Approves Software For iPhone-Based Vision Test

Posted by samzenpus on 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."

46 comments

  1. Re:1 in 4 in US? by Anonymous Coward · · Score: 0, Offtopic

    http://dictionary.reference.com/browse/Merkins

    ???

  2. Why the large proportion of US citizens? by Anonymous Coward · · Score: 1

    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?

    1. Re:Why the large proportion of US citizens? by Anne+Thwacks · · Score: 0

      One word: iPhones.

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      Sent from my ASR33 using ASCII
    2. Re:Why the large proportion of US citizens? by slew · · Score: 3, Informative

      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...

      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.

    3. Re:Why the large proportion of US citizens? by Lloyd_Bryant · · Score: 2

      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 (Lucentis) sells for about $2000 per dose. Fortunately, there is a closely related drug (Avastin) that is quite effective as well, and while it's not actually approved for AMD (it was developed and approved to treat colon cancer), most retina specialists have no problem using it "off label" for AMD patients.

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      Don't tell me to get a life. I had one once. It sucked.
    4. Re:Why the large proportion of US citizens? by Anonymous Coward · · Score: 0

      Whoah! I beg to differ too. If caught early enough, and you are lucky enough, wet AMD IS REVERSIBLE. That is why this test is so crucial. Discover a reoccurrence early and you can fix it!!!!

      I have seen numerous people who went from 20/30 to 20/200, got injections, and got back down to 20/30 again!

  3. Not at all by srussia · · Score: 5, Funny

    This is racist against phones that aren't iPhones.

    The iPhone is the only one with a retina display.

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    Set your phasers on "funky"!
    1. Re:Not at all by Anonymous Coward · · Score: 0

      Not correct.

      There are more phones with increased pixel density. Retina displays are not the only ones. And i believe the "test" has more about camera and software for image analysis then "screen" resolutions.

    2. Re:Not at all by Anonymous Coward · · Score: 0

      If you use an iPhone for... really, anything at all... you don't have any vision worth measuring.

  4. Re:1 in 4 in US? by radio4fan · · Score: 1

    Does seem a bit unlikely, even taking into account higher than average rates of diabetes in the US.

  5. What no Android versione? by mu22le · · Score: 1

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

    1. Re:What no Android versione? by Anonymous Coward · · Score: 0

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

      Don't bet on it; not as long as the FDA is practicing institutional racism.

    2. Re:What no Android versione? by ikaruga · · Score: 3, Interesting

      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.

    3. Re:What no Android versione? by Anonymous Coward · · Score: 0

      Who is the government to say what apps a person can use in their own home?

    4. Re:What no Android versione? by Anonymous Coward · · Score: 0

      So far as I can see under the EU's rules these would be type I non-sterile and non-measuring medical devices. Which means you can self-certify. All you have to do to sell such devices in the EU is read the rules, have a documented process for obeying those rules, and add the appropriate CE logo saying you've read the rules and self-certify as having obeyed them. In the event anything goes seriously wrong, they can prosecute if you didn't in fact obey the rules, but otherwise you're left alone to do your thing.

      To give you an idea, my mother, sat at home making kid's toys for sale to earn some extra money, was able to obey CE logo self-certification. She just kept a binder full of records of materials used, evidence of fire retardant testing, that sort of thing and it was always fine even when a kid's parent complained about a fault and the investigators came out they just checked the binder and everything was cool for my mother. This is not a big deal, is what I'm saying, if you can keep your tax records straight you're capable of achieving self-certification for these type I non-sterile non-measuring devices.

      The type I sterile and measuring devices (e.g. a needle, or a calibrated syringe) require external monitoring, which isn't cheap but also really won't break the bank for a product that already involves a smartphone. Only type II and above require the sort of oversight that would make applying to do this on other models of phone especially costly if someone wanted to.

    5. Re:What no Android versione? by Anonymous Coward · · Score: 0

      It would be about time that FDA and equivalent to stop approving specific devices then and start analysis of the software / results and provide a way to approve those as a start, and implement the same approval for any device that conforms with the test results required.

      After all we are on the age of software, not on the steam age...

    6. Re:What no Android versione? by RobertLTux · · Score: 1

      the part where this is classed as a Medical Device.

      Now im sure with a wide enough detune of the required tolerance this could be used on %smartphone%

      basically instead of giving numbers it reads back as
      1 Meh
      2 You might want to ring your doc
      3 You need to see your doc (while you still can see)
      4 WTFBBQ!!! DOC NOW!!
      5 911!!!!

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    7. Re:What no Android versione? by Silas+is+back · · Score: 1

      Well, even the FDA reckons this and a draft proposal has been out since October 2011, to be finalized this October: http://www.fda.gov/medicaldevices/productsandmedicalprocedures/ucm255978.htm

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      this sig is useless
    8. Re:What no Android versione? by Silas+is+back · · Score: 1

      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

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      this sig is useless
    9. Re:What no Android versione? by tlhIngan · · Score: 1

      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.

    10. Re:What no Android versione? by Silas+is+back · · Score: 1

      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). 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?

      And for developers the 400+ DPI create a new issue: how should you optimize images for your apps/websites? Do you go 3x the size the image has at standard resolution? Meaning you now have to create each image three times, despite nobody seeing a difference over the double-sized 320 DPI images? Vector images help, but are not the solution since lines will be blurred. Oh how we love numbers.

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      this sig is useless
    11. Re:What no Android versione? by Anonymous Coward · · Score: 0

      Why would vector lines be blurred? That demonstrates a big failure in understanding what vector images are.

  6. more excuses by Anonymous Coward · · Score: 0

    "in between visits with eye care professionals"
    Healthcare has similar business practices as cartels. "Don't forget to pay the middleman... Or else I won't sign this piece of paper that controls your life."

  7. Complaints by Anonymous Coward · · Score: 0

    You can contact the FDA here to file a complaint in regards to this racist decision.

  8. Hrmmm... by SGDarkKnight · · Score: 1

    So is it still the iPhone, or eyePhone now?

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    ...A no smoking section in a restaurant is like having a no peeing section in a swimming pool...
    1. Re:Hrmmm... by adibe · · Score: 1

      Obligatory: http://www.youtube.com/watch?v=8XOr6RVjdFc

  9. why not android? no need to hack to install your by Joe_Dragon · · Score: 2

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

  10. Re: why not android? no need to hack to install yo by Anonymous Coward · · Score: 1

    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.

  11. When will they approve skin-treatment apps? by moeinvt · · Score: 1

    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

  12. Already done.. by Anonymous Coward · · Score: 0

    I've already seen doctors use similar apps in the ER. Does this mean they were "illegal" or is this not the first approval?

  13. As a sufferer of eye disease... by ThomasBHardy · · Score: 1

    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 for a period of nearly 3 months. The field of distortion changed regularly and it was a frightening and isolating experience. I'd have jumped at the chance to use a tool like this to record my daily experiences and results and log them for my doctor. I can easily see where making an app like this required a known screen factor that makes the ambiguity of the Android marketplace tougher to use. No doubt once they have things running and approved on the iphone, if it proved profitable they would port it to Android for phones that meet certain display criteria.

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    Warning: Teh poster of this messaeg is lysdexic
  14. Re:why not android? no need to hack to install you by DerekLyons · · Score: 1

    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.)

  15. Bio-Digital Signature by saintmess · · Score: 1

    ... to get your bio-digital signature voluntarily

  16. I don't See any problem with this by Anonymous Coward · · Score: 0

    :p