FDA ratchets up mobile-health oversight with urinalysis app

05/24/2013 | Bloomberg Businessweek

The Food and Drug Administration has asked the developer of an iPhone medical diagnosis application why the company has not sought agency clearance for its uChek urinalysis system designed to check for blood, protein and other substances. Biosense Technologies is the first mobile app developer that the FDA has singled out for scrutiny. An FDA spokesman said the agency is limiting 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."

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