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.
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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.
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.
Top Rated Comments
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.
If the government was all about safety then Tobacco would be banned and we'd have 100% self-driving cars by now.
Easy answer. "It's not a medical device, it's a personal-use experimental tool" so go ****** youself FDA.
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.