FDA fires warning shot over smart phone bow

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.

Since then MIMvista has learned the device might eventually be approved by the FDA-but it will not be cleared. In a Jan. 29 letter to the company, the FDA stated “your device has new technological characteristics that could adversely affect safety and effectiveness and raise new types of safety and effectiveness questions…Therefore, this device is classified by statute into class III (Premarket Approval).”

The distinction between 510(k) clearance and PMA approval is lost on most people, even many in the medical device industry. A 510(k) clearance is the preferred route because the manufacturer need only show that a device awaiting commercialization is substantially equivalent to one already on the market. Approval comes only by documenting, often through clinical studies, that a device is both safe and effective.

The NSE (not substantially equivalent) letter from the FDA prompted MIMvista chief technology officer Mark Cain to restrict the app from download by American physicians. The company then began designing a clinical trial to gather data for a PMA application.

The MIMvista experience is sobering for radiologists who had hoped advances in consumer electronics would migrate easily to their discipline. It is also a cautionary tale for developers of medical imaging software designed for mobile electronics.

In its letter to MIMvista, the FDA stated that its decision was “based on the fact that your device has a new indication for displaying medical images for diagnostic use on a mobile/portable device.” Cain interprets this line to mean that software on any portable device requires FDA approval.

“Their emphasis was purely on portable and mobile devices,” he said. “The way I read this, laptops, iPads, anything that is carried around and used for diagnosis has no predicate and, therefore, is a class III device.”

At least three vendors currently offer iPhone apps designed to transmit medical images. CoActiv Medical Business Solutions unveiled versions of its EXAM-PACS software for the iPhone at RSNA 2009 and early this year for the iPad.

On March 1 Merge Healthcare released its eFilm Mobile on the iTune app store. The software allows users of eFilm Workstation v3.3 to access work lists and studies from an iPhone or iPod Touch.

Last month vendor iCRco announced iClarity, an app for viewing medical images on the iPhone.

All three are being marketed to U.S. radiologists. None has received FDA approval.

“All I can speak to is that we felt our device was designed for use as a medical device,” Cain said. “That is why we are on this (regulatory) journey now and that is why we are going to continue this until we get through the PMA process, as long and as hard as it may be.”