Doctors using mobile devices to read scans and make diagnoses… “There’s an app for that.”

February 5, 2011

The U.S. Food and Drug Administration (FDA) announced today that the agency has approved the first ever application that allows doctors to view medical scan images on mobile devices, Apple Inc.’s iPhone and iPad.

Hospital radiology departments or physician’s offices will soon be able to send images from computed tomography (CT), magnetic resonance imaging (MRI), and nuclear medicine technology such as positron emission tomography (PET), to a physician’s mobile device for examination and diagnosis. The new radiology software application developed by MIM Software Inc. of Cleveland, OH called Mobile MIM, will allow physicians to view, measure distance and contrast, and make notes on medical scan images received on their iPhone or iPad.

“This important mobile technology provides physicians with the ability to immediately view images and make diagnoses without having to be back at the workstation or wait for film,” said William Maisel, M.D., M.P.H., chief scientist and deputy director for science in the FDA’s Center for Devices and Radiological Health.

The FDA approved the use of Mobile MIM only when the physician has no access to a workstation. However, the Los Angeles Times reports that FDA spokesperson Erica Jefferson acknowledged that the agency would not know if physicians use the application on their mobile devices for the convenience instead of need.

The FDA worked with radiologists to evaluate the Mobile MIM app, finding it sufficient for diagnostic image interpretation under the recommended lighting conditions.

According to the FDA, the medical images may also look different from mobile device to mobile device, even between devices of the same model, due to significant variations in the luminance levels of the devices. Because of this, Mobile MIM will have a safety guide and carry “sufficient labeling and safety features to mitigate the risk of poor image display due to improper screen luminance or lighting conditions,” circumstances that could contribute to a potential misdiagnosis or error.

“Establishing a diagnostic protocol for medical imaging is no simple matter for a device like the iPhone or iPad,” said CTO of MIM Software Inc., Mark Cain. “It is critical to understand the characteristics of the device and to establish methods and tools that are safe and effective, while working within those constraints. There has been a gap in the market for a remote imaging device like this, and now it can be filled."

Physicians can purchase Mobile MIM from the US Apple Store next week.

"There’s an app for that." is a trademark of Apple Inc. and a widely recognized marketing campaign slogan for the hundreds of thousands of applications available for the iPhone and iPad devices.