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FDA, Medical Apps, Technology

FDA approves first diagnostic radiology application for mobile devices

Physicians will soon be able to view medical images on iOS devices using Mobile MIM, which today became the first diagnostic radiology application to be cleared by the Food and Drug Administration. According to an FDA release:

In its evaluation, the FDA reviewed performance test results on various portable devices. These tests measured luminance, image quality (resolution), and noise in accordance with international standards and guidelines. The FDA also reviewed results from demonstration studies with qualified radiologists under different lighting conditions. All participants agreed that the device was sufficient for diagnostic image interpretation under the recommended lighting conditions.

The display performance of mobile devices can experience significant variations in luminance levels even between mobile devices of the same model. 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. 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 app is available to download for free. The FDA states that the app is “not intended to replace full workstations and is indicated for use only when there is no access to a workstation.”

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