FDA Clears Diagnostic Radiology App

As the iPad nears its one-year anniversary, it is becoming clear that the device is capable of much more than just playing games and sending emails. And now, after receiving approval from the FDA, the iPad is being used for important science and medical research including making medical diagnosis.

The FDA recently cleared a radiology app for the iPad that allows physicians view medical images including MRI, CT and PET scans.

The new app is a software program called Mobile MIM, made by MIM Software, which allows radiology images taken in the hospital or physician's office to be compressed for secure network transfer and then sent to the portable wireless iPads.

"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," William Maisel, chief scientist and deputy director for science in the FDA's Center for Devices and Radiological Health, said in a statement.

However, the FDA said the app was "not intended to replace full workstations and is indicated for use only when there is no access to a workstation."

Still the approval of such as app as a complimentary, or ancillary, device in important medical settings is just one more step in the iPad's evolution from curiosity to integral instrument.

The primary concern among radiologists, and FDA officials, during testing was the software’s ability to transmit images under different lighting conditions to ensure the image display isn’t negatively affected by bad light or improper screen luminance on the iPad and iPhone, according to the FDA.

After measuring luminance, resolution, and noise against international standards and guidelines, the FDA determined the device was sufficient for diagnostic image interpretation under the recommended lighting conditions.

"The device includes an interactive contrast test in which a small part of the screen is a slightly different shade than the rest of the screen. If the physician can identify and tap this portion of the screen, then the lighting conditions are not interfering with the physician's ability to discern subtle differences in contrast," the FDA said.

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