iPhone Urinalysis App Draws U.S. Government Scrutiny

Discussion in 'MacRumors.com News Discussion' started by MacRumors, May 24, 2013.

  1. macrumors bot


    Apr 12, 2001

    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:
    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
  2. macrumors 6502

    Apr 26, 2011
    Next: enter nuclear launch codes inside iOS app.
  3. macrumors 68030


    Jul 30, 2010
    Glasgow, Scotland
    Cue class action from consumer group that have number 1'd all over their phone.
  4. macrumors regular

    Jan 17, 2006
    about 3 meters from here. *points*
    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.
  5. macrumors 6502


    Jul 21, 2010
    Orlando, FL
    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!
  6. macrumors 68030

    Krazy Bill

    Dec 21, 2011
    Time to resurrect, "There's an app for that!" campaign.
  7. macrumors 6502a


    Jan 4, 2002
    Austin, TX
    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.
  8. macrumors 603


    Sep 19, 2003
    Canada, eh?
    Yeah, you don't want to piss anyone off! :eek: :D

    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.
  9. macrumors regular

    Jan 8, 2013
  10. macrumors 65816

    Aug 24, 2007
    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.
  11. macrumors 6502

    Oct 29, 2002

    Easy answer. "It's not a medical device, it's a personal-use experimental tool" so go ****** youself FDA.
  12. macrumors 6502a


    Sep 29, 2008
    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).
  13. macrumors 6502

    Nov 2, 2011
    iObamacare :D.
  14. macrumors 68020


    Jun 18, 2009
    FEMA Region VIII
  15. macrumors 6502

    Nov 2, 2011
    They need to get back to not evaluating any statements.

    *Edit: I think I used the app wrong... *wipes urine off iPhone*
  16. macrumors 68030

    Krazy Bill

    Dec 21, 2011
    You should see page 2. :(
  17. macrumors 6502a

    Sep 16, 2007
    Indiana, US
    The government just wants all the urine for themselves! Wake up, America!!
  18. macrumors regular

    Jan 17, 2006
    about 3 meters from here. *points*
    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.
  19. macrumors 68030


    Sep 3, 2011
    Aye. Personally I don't trust auto-WB for my own family photos, let alone medical results.
  20. macrumors newbie

    Apr 6, 2012
  21. macrumors member

    May 29, 2012

    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
  22. macrumors 603

    Jun 19, 2009

    how do you know the app's results are real without any testing or verification?
  23. macrumors 68020

    Oct 14, 2011
    R. Kelly would approve
  24. macrumors 68000


    Mar 28, 2005
  25. macrumors member

    Jul 19, 2010
    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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