App Makers Crowdfund to Avoid Blindside Hit of FDA Rules
Published: Sep 06, 2013
It sounded like a good idea at the time: A smartphone application that tapped into a growing consumer desire to self-diagnose health ailments at home. Biosense Technologies Private Ltd. made a splash in February when it unveiled a kit that lets people use their phone cameras to read subtle color differences on test strips designed to show unhealthy levels of proteins and other substances in their urine. What the creators didn’t anticipate was the need for U.S. government approval.
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