Is This iPhone App Causing FDA Officials to Lose Sleep?

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Urine analysis is no longer the sole province of medical professions and laboratories. An application developed for Apple’s (NASDAQ:AAPL) iPhone enables individuals to check levels of blood, protein, and other substances in their urine. But, as this application puts medical analysis in the hands of anyone with access to an iPhone, United States regulators are seeking to put some limitations on the already burgeoning industry.

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Biosense Technologies’ uCheck system has not yet been cleared by the Food and Drug Administration because the agency wants to impose stricter rules for tools that directly diagnose medical conditions through automated analysis and offer treatment. In the case of uCheck, the system employs test strips manufactured by Siemens (NYSE:SI) and Bayer, which are then dipped in urine and read using the smartphone’s camera in order to produce automated results. The problem is that the strips are only approved for a visual reading and require new clearance for automated analysis, according to a letter sent to Biosense from the FDA. The company may also need to gain agency approval for the system as a whole.

The agency wants more oversight, and to further this mission, it imposed quality standards for heart stents, ultrasound machines, and other medical devices back in 2011.

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