Mobile MIM iPhone iPad radiology app cleared by FDA

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There is a renewed hope for medical app developers with approval of Mobile MIM, a radiology imaging software for smartphones.  It is worth noting that this is the first medical app that got FDA approval, which allows physicians to view medical images on iPhone and iPad and perform medical diagnosis.  FDA noted that the MIM app is not intended to replace full workstations and is indicated for use only when there is no access to a workstation. 

Mobile MIM software is developed to view medical images from tests such as computed tomography (CT), magnetic resonance imaging (MRI), and nuclear medicine technology, such as positron emission tomography (PET).  Mobile MIM allows the physician to measure distance on the image and image intensity values and display measurement lines, annotations and regions of interest. 

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 that “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.” 

Why would you need FDA approval for mobile app such as MIM?
The process of viewing images on smartphone involves compressing the images for secure network transfer, which is then sent to the appropriate portable wireless device.  If physician is diagnosing based on images on iPhone or iPad, it is critical that the decision should not be affected by the quality of images processed by Mobile MIM.  FDA reviewed performance test conducted by MIM on various portable devices.  The test measured:

  • luminance,
  • image quality (resolution), and
  • noise

in accordance with international standards and guidelines.




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Along with these tests, reviewers evaluated results from demonstration studies with qualified radiologists under different lighting conditions before coming to consensus regarding its performance.  

What controls are in place to take care of performance issues with MIM?
One of the big concerns regarding MIM software is that the display performance of mobile device can affect the luminance levels of the digital images.  To take care of this problem, a label and safety measure is included in MIM. MIM actually came up with an innovating solution to the light problem by developing an interactive contrast test.  A small portion of the screen has slightly different shade than the rest of the screen and 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.  In addition, a safety guide is included within the application. 

I think approval of Mobile MIM is good news for mhealth industry.  There are many questions around regulations to be imposed on mhealth and this approval signifies that FDA is willing to work with developers on this upcoming medical diagnostic field.  Also, FDA approved product establish credibility among the users and give manufacturers power to charge premium price for their product. 

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