Is This iPhone App Causing FDA Officials to Lose Sleep?

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.

“We intend to finalize the guidance this year,” agency spokeswoman Synim Rivers told Bloomberg Wednesday via email. “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.”

In February, the app required to run the automated system was praised at the technology conference TED2013, and it became available in Apple’s app store earlier this year. But the problem of FDA approval lingers.

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The agency wrote a letter to Biosense on May 22 detailing its concerns. Co-founder Abhishek Sen said that the company intends “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,” according to Bloomberg. But he declined to give any further information regarding his communications with the agency.

This letter gave Biosense the opportunity to meet and discuss the issue. Depending how the company responds, the FDA may follow up with warning letter that details specific violations of the law that must be rectified immediately, Rivers said. The regulator suggested a 510k application, which is the least stringent of FDA device approval pathways, as a possible solution. It only requires the company to prove their product is similar to one on the market. As the letter noted, Acon Laboratories has already submitted data for its urine analyzer.

Follow Meghan on Twitter @MFoley_WSCS

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