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Mobile MIM application FDA approved for iPad, iPhone medical imaging

Mobile MIM application FDA approved for iPad, iPhone medical imaging

The U.S. Food and Drug Administration cleared the first diagnostic radiology application for mobile devices, providing wireless access to medical images for iPhone, iPad users.

The U.S. Food and Drug Administration cleared a new mobile radiology application, allowing doctors to view medical images on the iPhone and iPad manufactured by Apple Inc. It is the first app cleared by the FDA for viewing images and making medical diagnoses based on computed tomography (CT), magnetic resonance imaging (MRI) and nuclear medicine technology, such as positron emission tomography (PET). It is not, however, intended to replace full workstations, and should only be used by doctors when a full workstation is not accessible, the FDA indicated.

“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 reviewed performance test results on a variety of portable devices, measuring luminance, image quality/resolution and noise in accordance with international standards and guidelines. Additionally, a range of lighting conditions were evaluated. All participants in the evaluation agreed that the device was “sufficient for diagnostic image interpretation under the recommended lighting conditions,” the FDA said in a release.

While display performance of mobile devices can vary significantly under a variety of conditions, the Mobile MIM application “includes sufficient labeling and safety features to mitigate the risk of poor image display due to improper screen luminance or lighting conditions,” according to the FDA. Specifically, the device has an interactive screen test, which is shaded slightly different than the rest of the screen. If the doctor can see and touch this variation on the screen, then lighting conditions are not interfering with subtle variations in contrast or the physician’s ability to see and recognize them.

Mobile MIM is manufactured by Cleveland-based MIM Software Inc.

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