Posted on 02/05/2011 8:13:52 PM PST by Swordmaker
WASHINGTON -- The FDA has moved into the "got an app for that" market by approving the first diagnostic radiology application for the iPhone and the iPad.
In announcing the approval, the FDA said the application can be used to view results of CT, MRI, and PET scans on the mobile devices and use those images to make diagnoses.
But the agency noted that the app was "not intended to replace full workstations and is indicated for use only when there is no access to a workstation."
"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," said William Maisel, MD, MPH, chief scientist and deputy director for science in the FDA's Center for Devices and Radiological Health in a statement.
The new "device," which is designed for use with Apple products, is a software program called Mobile MIM, made by Cleveland's MIM Software.
The software allows radiology images taken in the hospital or physician's office to be "compressed for secure network transfer then sent to the appropriate portable wireless device," according to the FDA statement.
The images are then viewed on the iPhone or iPad in a format that "allows the physician to measure distance on the image and image intensity values and display measurement lines, annotations and regions of interest."
The FDA said it evaluated the app by testing its performance on a number of devices, measuring luminance, resolution, and noise against international standards and guidelines.
The FDA said it, "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."
In announcing the approval, the FDA noted that mobile devices have a wide range of variation in luminance even among the same model devices.
"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 FDA said.
MIM is including a safety guide within the application.
Now that's funny.
Just to make it clear...I think this is a great thing, as an iPhone and iPad user, and I am sure some of the rads will think so too.
Flexibility and choice...
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