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FDA Approves Software For iPhone-Based Vision Test 46

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 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.

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