As reported in the Wall Street Journal, the FDA announced last Friday that it has cleared the first mobile radiology application, allowing iPhone and iPad users to read medical images on their mobile devices. The application, called Mobile MIM and manufactured by Cleveland-based MIM Software Inc, allows physicians to view images and make medical diagnoses on CT, MRI, and PET images when they do not have access to a workstation.
The software compresses images taken in the hospital or physician's office and transmits them over a secure network to an appropriate portable wireless device. When viewing the image on their device, the software also allows the physician to measure distance on the image and image intensity values and display measurement lines, annotations and regions of interest.
In evaluating the software, the FDA carried out performance tests on various portable devices, measuring luminance, image quality, and noise in accordance with international standards and guidelines. The FDA also tested the device under different lighting conditions with qualified radiologists, all of whom agreed that the mobile device would be acceptable for diagnostic image interpretation as long as recommended lighting conditions were met.
To allay concerns of misuse under inappropriate conditions, Mobile MIM includes safety measures to mitigate the risk of inaccurate image display under inappropriate lighting conditions. One of these measures requires physicians to interactively demonstrate their ability to determine subtle differences in contrast, requiring them to tap a small part of the screen that is slightly darker in shade than the rest of the screen. The FDA's approval of Mobile MIM will likely open up increasing investment in similar mobile applications, breaking down a regulatory barrier that had, until this point, seemed impassable.