FDA App Enforcement, in Medical Device and Diagnostic Industry

Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, wrote an article "Wanted: FDA App Enforcement."

Following is an excerpt:

I need help figuring this out. A pretty innovative guy named Myshkin Ingawale of Biosense Technologies, Mumbai, India two weeks ago stood in front of the audience at TED (Technology, Education and Design) in Los Angeles and announced that he was introducing through Apple's App Store an app that lets you test your urine. It got quite a bit of attention among the blogs with plenty of jokes about having to pee on your iPhone.

It actually sounds quite cool. No, you don't pee on your iPhone, but rather you do the test mostly the old-fashioned way of peeing into a cup and then inserting a test strip. All the app does is objectively read the results using the camera on the phone. According to a company press release, the plan is to make the app available from the App Store for 0.99 cents and the uChek kit consisting of the uChek color mat to calibrate the app plus 5 sample urine dipsticks for $19.99 through the company's Web site.