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The real reason is so that the Federal Government can tax this app's sales. Besides all it does is take a photo of an already-approved (taxed) test strip and include a database function. It does not perform any actual tests itself like a blood-glucose meter does.

If the government was all about safety then Tobacco would be banned and we'd have 100% self-driving cars by now.

We don't have self driving cars because CV technology isn't up to snuff for driving cars yet. I was working on making an app that monitors cars but I found that CV just can't pick up objects like cars quickly enough and accurately enough to be reliable enough to do things like drive cars safely and quickly. I'm sure it'll get there within the decade, but it's not there yet.
 
The real reason is so that the Federal Government can tax this app's sales. Besides all it does is take a photo of an already-approved (taxed) test strip and include a database function. It does not perform any actual tests itself like a blood-glucose meter does.

Or not. It could be that they want to make sure he app is doing its job correctly. Imagine if it gave a wrong result and someone ended up in the hospital. Or dead.
 
So… Is this device food? Or is it a drug? I was under the impression that it was something that you peon. Maybe I am mistaken. I can't see why the FDA thinks they would have any jurisdiction over that.
Because the FDA DOES have jurisdiction over medical testing devices. They approve all of those pee-on-a-strip tests for pregnancy/ovulation. They have jurisdiction over home glucose test machines and home blood pressure machines. This is written into their charter. Part of why they exist is to prevent dangerous or at the least ineffective patent medicines and health machines.

From the article
Biosense Technologies Private Ltd.'s uChek system isn't cleared by the Food and Drug Administration and the agency said it wants to know why not,
The FDA is not demanding the system be pulled, they are asking the manufacturer to explain why this is not the same as the devices they already have jurisdiction over and have to approve.
 
So… Is this device food? Or is it a drug? I was under the impression that it was something that you peon. Maybe I am mistaken. I can't see why the FDA thinks they would have any jurisdiction over that.

Most original use of 'peon' ever. *applause*
 
The real reason is so that the Federal Government can tax this app's sales. Besides all it does is take a photo of an already-approved (taxed) test strip and include a database function. It does not perform any actual tests itself like a blood-glucose meter does.

If the government was all about safety then Tobacco would be banned and we'd have 100% self-driving cars by now.

Woah, there cowboy!

The govenment doesn't need to use the FDA to tax anything, so you are making no sense. And there are several things that could go wrong here. The camera needs to be working well enough, the app needs to process the image correctly and display the results correctly. The FDA approval process should ensure that uChek has put into place sufficient quality control and verification.

The Tobacco and self-driving car stuff is important stuff, but completely irrelevant... If you are concerned about those, you should be posting comment on stories with some relation to those topics.
 
*I think I used the app wrong... *wipes urine off iPhone*

"You're not holding it right." (There's at least a triple entendre there. :D)

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how do you know the app's results are real without any testing or verification?

Each next-generation iPhone will have a unique iPee address that is associated with a database record and is supported by verification algorithms.
 
Screw the FDA. Here's another government agency that directly results in skyrocketing health care costs and overregulation of helpful devices and ideas such as this one.
 
This is front page worthy? Seriously?

All sorts of shenanigans is front page worthy for this site nowadays. They posted about the Xbox One when it was announced. What the hell does the Xbox one have anything to do with Apple news or rumors? Nothing. Including this.

Though I understand them. There is hardly any news to report on other than silly "leaked" iPhone parts. :(
 
You just know there will be someone returning their iPhone to an Apple store with the wet strip indicators inside the iPhone triggered because they peed on the iPhone while trying to get the app to work!



Easy answer. "It's not a medical device, it's a personal-use experimental tool" so go ****** youself FDA.

Careful now! Government regulators will write another 500 pages to add to the 20,000+ pages for Obamacare and change the taxing status applied to "medical device" to also include taxing "personal-use experimental tool"!


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This only makes any sense if the FDA undertake to test submitted apps for free since if you dont you limit the creation of apps to ..... wait for it.....

drug companies who can afford it
It's the fed, so "for free" still means they'll grossly overpay their incompetent selves with our money.
And said drug companies will still have an expedited revolving door, when they show up with giant sacks--sporting the classic ($) sign on em.

The Food and Drug and App Administration...
This will all end in tears.

Or not. It could be that they want to make sure he app is doing its job correctly. Imagine if it gave a wrong result and someone ended up in the hospital. Or dead.

Even stupid video games have 50 pages of terms and conditions to ensure they aren't liable for anything ever.
Big bold letter: THIS IS A TOY, GO SEE A DOCTOR.

People will die.
99% will be idiotic user error.
I believe in Application Darwinism.
 
You don't need a cameraphone to read a urine dipstick, you only need a pair of eyeballs. Unless you're colorblind or just plain blind, I guess.
 
You want to make sure you're in the correct kind of light, and that the camera properly white balances before you accept the photo for analysis, that's for sure!

Yes, I was about to say that. Under different lighting conditions yellow can look orange and blue look purple. The human eye adapts easy but cameras not.

As a video editor doing color correction all the time, the readings can be all wrong, period. You need an specific light condition to be able to take that picture from just one proper distance.
 
The real reason is so that the Federal Government can tax this app's sales. Besides all it does is take a photo of an already-approved (taxed) test strip and include a database function. It does not perform any actual tests itself like a blood-glucose meter does.

If the government was all about safety then Tobacco would be banned and we'd have 100% self-driving cars by now.

Sorry, that's BS. The FDA has to look into all medical devices and drugs and since here clinical parameter are analyzed it has to be involved. As all data sending stuff has to go to FCC, all medical has to be approved by FDA to make sure that somebody doesn't read he has high urine sugar and even protein in it, thinks he has diabetes, gets drugs or commits suicide and it turns out the app was not calibrated or reading (or what ever) properly. Is the database reliable?
Heck, we are using an approved imaging agent for a something slightly different and we are talking with the FDA.
 
Easy answer. "It's not a medical device, it's a personal-use experimental tool" so go ****** youself FDA.

So you regularly take drugs or medical treatments that haven't been approved by the FDA? Buy your drugs from Mexico?
Otherwise, I'm curious what your gripe is that's the source of your snarky attitude towards an agency that does us all a lot of good.

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You don't need a cameraphone to read a urine dipstick, you only need a pair of eyeballs. Unless you're colorblind or just plain blind, I guess.

Yes, I'm color blind. Got another reason to be such a jerk about this product?
 
The real reason is so that the Federal Government can tax this app's sales. Besides all it does is take a photo of an already-approved (taxed) test strip and include a database function. It does not perform any actual tests itself like a blood-glucose meter does.

If the government was all about safety then Tobacco would be banned and we'd have 100% self-driving cars by now.

You are right in that this device does not perform any acutal tests; however, it does perform the most important step of all - the interpretation of said tests.
While I am almost always for less government oversight, IMHO if the FDA lets this through it opens a pandora's box that will make a lot of lawyers much richer and that's the last thing we need.
 
As a Pro photography and this is based on color your going up against different light temperatures in various environments and there is no way something shot under interior house lighting would match something shot under outdoor light. The kelvin temp is 3200 for incandescent light and 5500 for daylight. Yellow for instance would have a much bigger yellow bias under incandescent light. Unless you white balance the image than it would have false readings. Not unless I'm reading this wrong but does not sound very accurate.
 
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