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The Boston Globe

Business

IPhone urinalysis app draws FDA inquiry

WASHINGTON — An iPhone application that lets users check levels of blood, protein, and other substances in their urine is the first target of US regulators seeking boundaries in a burgeoning industry for medical diagnosis on-the-go.

Biosense Technologies Private Ltd.’s uChek system isn’t cleared by the Food and Drug Administration and the agency said it wants to know why not, in a first-of-its-kind letter to a maker of a mobile device application. The app relies on users, such as diabetics checking their glucose, to dip test strips in urine and use the smartphone’s camera to allow the system to process and generate automated results.

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