As you learned from MobiHealthNews this week, MIM Software received a second FDA 510(k) clearance for its MobileMIM radiology app. In this case, the Food and Drug Administration approved MobileMIM radiology app for viewing x-rays and ultrasound images for diagnostic purposes. The federal agency also cleared the iPhone and iPad app for reviewing and approving of radiation therapy plans.

"Adding the additional modalities frees this up as a general radiology tool," MIM Software CTO Mark Cain says in an interview with MobiHealthNews. "We're finally seeing a general acceptance of mobile tools," Cain reports. "It's been a slow process."

Mobile devices can be "sub-optimal" for viewing detailed images, Cain says. This is particularly true for the iPhone's screen, which is tiny when compared with a fixed radiology workstation. "It's more time-consuming to read an image on one of these devices."

For this reason, the Cleveland-based company is marketing Mobile MIM as a convenience, not as a substitute for a traditional radiology setup. "It's like a police officer having a gun," Cain explains. "You would hope you wouldn't have to use this, but what do you do when you can't get to a workstation?"

Cain continues, "You can get that second opinion when it used to be very difficult to get."

The app also can come in handy for low-resource hospitals that can't afford to keep a radiologists on site around the clock and that don't want to contract for teleradiology services. "There are many interesting use cases that can come out of this," Cain says.

Initially, MobileMIM was intended for remote diagnosis. "I think that our original intention as a reference tool for radiologists, I think that is going to finally start to expand," according to Cain.

The MIM CTO recalls hearing about a surgeon who called a radiologist wanting to review images before operating, looking to ensure he was performing the right procedure. "That was one use we didn't even think about," Cain says.

Cain also says he read a story about a surgeon who was struggling with a particular case, so the doctor took the patient's images home on his mobile device over a weekend to take another look when the mood struck. The surgeon was able to discover a safer, more effective way to operate, Cain reports.

With this clearance, Mobile MIM has no applications pending before the FDA, Cain says.

The way the rules are written, do not expect Mobile MIM—or other companies that turn phones and tablets into medical image readers—to develop versions for Android or any other non-Apple platform. “We hear that question all the time: Why don’t you have an Android app?” Cain says. The answer is rather simple.

Depending on the intended use, the FDA may treat each type of device as a unique product, requiring its own review and clearance. In this case, the display is a critical feature of the product, Cain says. Android is an open-source operating system that runs on dozens if not hundreds of different products from multiple manufacturers, each with differing display characteristics—and there are multiple versions of Android, too. It would be prohibitively expensive to seek FDA approval on all the popular Android devices, according to Cain.

MIM only needed clearance for its software on the iPhone, iPad and iPod Touch, Cain explains. Even though there are several models of each, most run the new iOS 5. "Apple makes it fairly simple," he says.