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News Link • Technology: Software

FDA Asks For Data On Urine-Test App

•, By Francie Diep
 An iPhone app that reads urine sticks for you will now have to get U.S. Food and Drug Administration approval.
 The administration sent Silicon Valley-based Biosense Technologies a letter asking for data that shows its uChek app works as advertised. Bloomberg called the letter the first of its kind.

Could this be the start of more FDA oversight into medical smartphone apps? The agency first announced it would regulate medical apps in 2011, but officials are still working on final guidelines. They intend to finalize the guidelines this year, agency spokeswoman Synim Rivers told Bloomberg. In the meantime, health apps have proliferated without clear rules about what tests they have to undergo and whether they fall under the FDA's purview at all.

UChek is designed to use a smartphone's camera to automatically read colors on home urine dipsticks that are made by other companies and are already FDA-approved. The sticks detect 10 characteristics in urine, including pH, the presence of glucose, levels of different kinds of proteins and the presence of blood.

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