"Most of the applications filed by companies to the FDA that have been outright declined have been declined because the software runs resident on the device itself," Osing said. "In almost all the cases the data files have to be pushed out to the device for processing. In that case, the company would then have to prove that the device itself had the processing power and memory to be a, 'de facto PACs or advanced workstation'," he said.
"That makes it difficult for anybody with that kind of architecture because handheld devices don't have that kind of memory."

Clinical studies
Calgary Scientific has run three major clinical studies at two research hospitals in the United States and one in Canada, Osing said. Although because of a non-disclosure agreement with the hospitals, which are looking to publish the work in scientific journals, he declined to say which ones.

He said the studies uncovered a near-perfect correlation in the ability to diagnose on the handheld and a monitor; a couple of the studies even showed there was a 25 percent better visual capability in terms of clarity and pixelation on handhelds than older PACS workstations.

And the main use, according to Osing: the stroke scenario. While many hospitals have access to CT scanners, a lot don't have round-the-clock specialists. Patients entering the emergency room showing acute stroke symptoms might have to be packed into a helicopter and sent to a hospital where their condition could be diagnosed and clot-busting agents delivered to save their lives and preserve brain function. But with his company's app, a scan could be transmitted immediately to an on-call radiologist - wherever he is, he could be at home - delivering a notification to come and do a full diagnosis off of the image that came from the scanner.

"What it does in essence, it saves lives, it saves long-term neurological damage and huge costs to the medical system," Osing said. "Instead of a medical bill of a few thousands dollars - if you have long-term neurological damage, you're in the hundreds of thousands of dollars of health care costs."

But it remains to be seen if the FDA agrees. Calgary Scientific has already begun the application process. "They're now studying...our application very carefully," Osing said. "We're in the wait-and-see-how-it-goes [phase]."

The company is not alone in launching clinical trials to provide real, hard data to replace what's currently mostly speculation. Two months ago, Merge started a pilot project with Massachusetts General Hospital to determine where imaging mobile can assist in the clinical workflow. The company is also looking eagerly at the bigger viewing real estate offered by that much-hyped-for-health-care device: the iPad.

"It's going to be really interesting," said Merge's Kulbago about what he considers the still largely open future for mobile in medicine. "It's kind of the story of the microwave oven: nobody had the desire to cook a hotdog in 30 seconds before the microwave came along. Now, why would you wait more than 30 seconds to cook a hotdog?"

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