FDA fires warning shot over smart phone bow

(DIAGNOSTIC IMAGING) -- Smart phones are the tip of a new spear in information technology. They can help you get directions when lost in an unfamiliar city, even turn on the lights at home when you’re blocks away. Radiologists see other uses. They might use mobile devices to receive and send images to each other and to referring physicians. Some are already using them this way. And that’s all fine and good, so long as the makers of the software that runs on these smart phones are careful. Very careful.

Take the case of MIMvista. Two years ago, the company released an app called Mobile MIM, which puts medical images in the hands of iPhone users. The app was available for download from the Apple iTune App Store—and still is if you work in the U.K., Australia, Hong Kong, Singapore, and India. But American physicians will have to wait until they can use this app.

In early 2008, MIMvista was swimming in the safe harbor of “nondiagnostic use,” a regulatory gray area that some vendors say precludes the need for FDA review. Concerned, however, that the product was a true medical device, developed and designed to support diagnosis, MIMvista submitted a 510(k) application to the FDA. Soon after, regulators told the company to pull its software from the iTune App Store, warning the company that it was marketing a medical device without FDA clearance.

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