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Old May 24, 2013, 01:33 PM   #1
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iPhone Urinalysis App Draws U.S. Government Scrutiny




The U.S. Food and Drug Administration has sent a letter to BioSense Technologies over its iPhone uChek urinalysis system, asking why its medical app hasn't been cleared by the agency. The app is one of the first that turns the iPhone into a medical device, designed to read urinalysis test strips that are normally examined by users and compared to a color-coded chart.

With the uChek system, patients can take a picture of the strip with the iPhone's camera and then receive an automated readout of parameters like glucose, urobilinogen, pH, ketone and more. The app also stores results which then can be analyzed over time.

Though medical device makers have adopted the iPhone for some measurements like blood glucose monitoring for diabetics, large scale use of smartphones and tablets as a replacement for existing medical devices has yet to take off -- likely due in large part to government regulation of medical devices.

From Bloomberg:
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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, in a first-of-its-kind letter to a maker of a mobile-device application. The app relies on users, such as diabetics checking their glucose, to dip test strips in urine and use the smartphone's camera to allow the system to processes and generate automated results.

UChek works with test strips made by Siemens AG (SIE) and Bayer AG (BAYN), which are only approved for visual reading and require new clearance for automated analysis, the FDA said in the letter. The agency has said it wants stricter rules for apps that directly diagnose or treat conditions, proposing in 2011 to apply similar quality standards as for heart stents, ultrasound machines and other medical devices.
The uChek kit can be purchased in the US and India for $40, while the uCheck iPhone app is a free download [Direct Link] from the App Store -- though the app can also manually read urine strips from other companies.

Article Link: iPhone Urinalysis App Draws U.S. Government Scrutiny
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Old May 24, 2013, 01:34 PM   #2
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Next: enter nuclear launch codes inside iOS app.
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Old May 24, 2013, 01:38 PM   #3
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Cue class action from consumer group that have number 1'd all over their phone.
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Old May 24, 2013, 01:38 PM   #4
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Good idea, but valid point

As a medical professional (in training) I'm always excited to see the use of iOS devices to make monitoring easier. Patients in rural areas are particularly disadvantaged in the monitoring area, so new apps like this help to level the playing field.

That said, I'm glad that the FDA is keeping tabs on apps - the last thing that anyone wants are patients/healthcare providers making decisions based on results from un-vetted apps.

I'm sure that the Urinalysis App has great intentions, but there is an acceptance process for a reason.
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Old May 24, 2013, 01:40 PM   #5
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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!
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Old May 24, 2013, 01:40 PM   #6
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Time to resurrect, "There's an app for that!" campaign.
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Old May 24, 2013, 01:41 PM   #7
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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.
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Old May 24, 2013, 01:41 PM   #8
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Location: Canada, eh?
Quote:
Originally Posted by macaddict06 View Post
As a medical professional (in training) I'm always excited to see the use of iOS devices to make monitoring easier. Patients in rural areas are particularly disadvantaged in the monitoring area, so new apps like this help to level the playing field.

That said, I'm glad that the FDA is keeping tabs on apps - the last thing that anyone wants are patients/healthcare providers making decisions based on results from un-vetted apps.

I'm sure that the Urinalysis App has great intentions, but there is an acceptance process for a reason.
Yeah, you don't want to piss anyone off!

But seriously, you're right. You don't want to rely on inaccurate results generated because your particular iPhone wasn't calibrated correctly or your room lighting was inadequate or whatever. A great idea, but we need to be careful.
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Old May 24, 2013, 01:42 PM   #9
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Disgusting.
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Old May 24, 2013, 01:44 PM   #10
cameronjpu
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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.
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Old May 24, 2013, 01:45 PM   #11
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.|..

Easy answer. "It's not a medical device, it's a personal-use experimental tool" so go ****** youself FDA.
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Old May 24, 2013, 01:45 PM   #12
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Quote:
Originally Posted by macaddict06 View Post
As a medical professional (in training) I'm always excited to see the use of iOS devices to make monitoring easier. Patients in rural areas are particularly disadvantaged in the monitoring area, so new apps like this help to level the playing field.

That said, I'm glad that the FDA is keeping tabs on apps - the last thing that anyone wants are patients/healthcare providers making decisions based on results from un-vetted apps.

I'm sure that the Urinalysis App has great intentions, but there is an acceptance process for a reason.
Why should it need FDA approval? That's only really needed if it will be used by medical professionals as part of patient care. It people use it of their own accord as part of routine lab work, this doesn't need FDA approval. People just have to realize that while the results might be valid they should not replace care by a competent medical professional.

Medical professionals should not be using things like this without FDA approval (although there are a number of clinical lab tests that are not FDA-approved but are still frequently run; I was just reading a patient's chart where a number of standard labs had been run and a couple of them had large disclaimers that the test was not FDA-approved).
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Old May 24, 2013, 01:46 PM   #13
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Originally Posted by notjustjay View Post
Yeah, you don't want to piss anyone off!

But seriously, you're right. You don't want to rely on inaccurate results generated because your particular iPhone wasn't calibrated correctly or your room lighting was inadequate or whatever. A great idea, but we need to be careful.
iObamacare .
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Old May 24, 2013, 01:46 PM   #14
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This is front page worthy? Seriously?
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Old May 24, 2013, 01:48 PM   #15
Fandongo
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Easy answer. "It's not a medical device, it's a personal-use experimental tool" so go ****** youself FDA.
They need to get back to not evaluating any statements.

*Edit: I think I used the app wrong... *wipes urine off iPhone*
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Old May 24, 2013, 01:49 PM   #16
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This is front page worthy? Seriously?
You should see page 2.
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Old May 24, 2013, 01:57 PM   #17
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The government just wants all the urine for themselves! Wake up, America!!
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Old May 24, 2013, 01:59 PM   #18
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Originally Posted by TheRealTVGuy View Post
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!
I'd imagine that there is a portion of the strip that serves as an internal standard for exposure, i.e a specific area that is blank white and allows the software to correct for WB, etc.
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Old May 24, 2013, 02:02 PM   #19
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Originally Posted by TheRealTVGuy View Post
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!
Aye. Personally I don't trust auto-WB for my own family photos, let alone medical results.
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Old May 24, 2013, 02:04 PM   #20
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can't wait to pee on an iphone
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Old May 24, 2013, 02:06 PM   #21
elvetio
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,,,

these are the rules, if you want to innovate in this sector you have to lobby a few millions. no exceptions accepted guys.. you should know this by now
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Old May 24, 2013, 02:11 PM   #22
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Originally Posted by Sayer View Post
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.

how do you know the app's results are real without any testing or verification?
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Old May 24, 2013, 02:12 PM   #23
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can't wait to pee on an iphone
R. Kelly would approve
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Old May 24, 2013, 02:15 PM   #24
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This whole story takes the p...
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Old May 24, 2013, 02:17 PM   #25
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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
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