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Biosense Technologies' uChek system turns Apple's iPhone into a capable urinalysis device, and now the Food and Drug Administration is saying that it may need to clear the medical app lest developers risk violating federal law.
UChek relies on test strips from Siemens and Bayer, and those strips are only approved for visual reading, according to Bloomberg. uChek's app, though, uses the iPhone's camera to analyze the testing strip and return a result for a user.
The FDA has sent a letter to the system's developers, saying that the agency was concerned about uChek's usage and that Biosense should contact the agency to discuss the app.
"We intend to work very closely with the U.S. FDA over the coming months to ensure that we continue to deliver accurate, affordable, and convenient diagnostics across the world," Biosense's founder told Bloomberg.
Since it is used for diagnostic functions, uChek falls under the purview of the FDA, which has been looking to restructure its regulations in order to handle the increasing presence of iOS devices in the medical field.
"We intend to finalize the guidance this year," an agency spokesperson told Bloomberg. "The FDA has proposed a regulatory approach that limits its immediate oversight to a specific, small subset of mobile medical applications that are medical devices and present the greatest risk to patient safety if they don't work as intended."