FDA Regulators Eye Medical Apps for Mobile Devices

In February, Biosense Technologies Private Ltd. made a splash when it unveiled uChek, a mobile application and companion kit that lets people use their phone cameras to read subtle color differences on urine test strips. The creators of uChek say their invention can help determine an individual’s risk for more than 25 medical conditions, including diabetes and hepatitis. What they didn’t anticipate is the need for government approval to sell their product in the U.S.

On May 21, less than a month after making its first sale stateside, Biosense, based in Thane, India, received a letter from the U.S. Food and Drug Administration indicating that the company might need to seek clearance for its product. The letter signaled a push by the agency to regulate smartphone apps that tap into a growing consumer desire to self-diagnose health ailments. “There’s a gigantic gulf between the tech industry and the medical regulatory infrastructure,” says David Jones Jr., chairman and managing director of Chrysalis Ventures, a Louisville-based venture capital firm that specializes in health-care and technology investments.