App Makers Crowdfund to Avoid Blindside Hit of FDA Rules

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. Now Biosense is adjusting to a new reality. After receiving a letter from the Food and Drug Administration questioning the company’s lack of regulatory clearance, Biosense has stopped selling its kit in the U.S. and now plans to seek approval. The letter offered a glimpse into a new push by the FDA to set boundaries in how apps are used for medical care. “There’s a gigantic gulf between the tech industry as a whole and the medical regulatory infrastructure,” David Jones, chairman and managing director of venture capital company Chrysalis Ventures, said in an interview. To bridge that gap, Biosense, a closely held company based in Thane, India, decided to put the future of its product, called uChek, at the mercy […]

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