The App, called Mobile MIM, has been available for use in Ireland and the UK by medical professionals since December 11 2010.
With the approval US doctors will be able to assess and make clinical decisions of “computed tomography (CT), magnetic resonance imaging (MRI), and nuclear medicine technology, such as positron emission tomography (PET).”
William Maisel, M.D., M.P.H., chief scientist and deputy director for science in the FDA’s Center for Devices and Radiological Health said, “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.”
Approval of the App in the States, was delayed while the FDA raised concerns that image resolution, screen glare and contrast issues could interfere with diagnosticians’ ability to properly interpret the images.
The FDA was concerned that the screen brightness and ambient light could mask parts of the image needed for a correct diagnosis. The application was passed thanks to its use of screen brightness controls, significant safety warnings and an on-screen safety guide.
However, the FDA warned that the App is not designed as a replacement of medical workstations but should only be used when access to full medical-viewing equipment is not available.
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