You thought your mobile devices only told time, read you a book and kept your calendar. Surprise! Today the FDA approves a new mobile radiology Microsoft application that will allow physicians to view medical images on the iPhone and iPad manufactured by Apple Inc.

The very first application of its kind is the first cleared by the FDA for viewing images and making medical diagnoses based on CAT and MRI readings, so a physician can be on the go, as usual.

William Maisel, M.D., M.P.H., chief scientist and deputy director for science in the FDA’s Center for Devices and Radiological Health states:

“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.”

An MRI machine uses a powerful magnetic field to align the magnetization of some atoms in the body, and radio frequency fields to systematically alter the alignment of this magnetization. This causes the nuclei to produce a rotating magnetic field detectable by the scanner, and this information is recorded to construct an image of the scanned area of the body. Strong magnetic field gradients cause nuclei at different locations to rotate at different speeds. 3-D spatial information can be obtained by providing gradients in each direction.

X-ray computed tomography (CT or CAT) is a medical imaging method employing tomography created by computer processing. Digital geometry processing is used to generate a three-dimensional image of the inside of an object from a large series of two-dimensional X-ray images taken around a single axis of rotation.

Radiology images taken in the hospital or physician’s office are compressed for secure network transfer then sent to the appropriate portable wireless device via software called Mobile MIM. Mobile MIM, manufactured by Cleveland-based MIM Software Inc., allows the physician to measure distance on the image and image intensity values and display measurement lines, annotations and regions of interest.

MIM 5 adds a new level of flexibility by providing customizable display protocols and workflows that work together to open studies just as the end user wishes. Doctors will be able to load data into several protocols through one workflow and switch between them with a keystroke.

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.

However, 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. In addition, a safety guide is included within the application.

In addition, MIMcardiac provides traditional analysis of perfusion and function for PET and SPECT. 3D/4D cardiac image volume sets can be aligned and displayed in ASNC format using standard MIM manual and automatic image registration with true color fusion display.

Multi-modality display automatically accounts for differences in voxel size between image volumes. MIMcardiac creates normalized subtraction images from aligned cardiac images that highlight perfusion differences and perfusion/metabolism mismatches.

Source: Food and Drug Administration

Written by Sy Kraft, B.A.