FDA clears first diagnostic radiology application for mobile devices
The U.S. Food and Drug Administration this week cleared a mobile radiology application that lets physicians view medical images on the Apple iPhone and iPad. It is the first application cleared by the FDA for viewing images and making medical diagnoses based on computed tomography, magnetic resonance imaging (MRI) and nuclear medicine technology, such as positron emission tomography (PET).
Radiology images taken in the hospital or physician’s office are compressed and then sent over a secure network to a portable wireless device via Cleveland-based MIM Software’s Mobile MIM suite. The software lets physician measure distance on the image, image intensity values, display measurement lines, annotations and regions of interest, according to the FDA.
“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, chief scientist and deputy director for science in the FDA’s Center for Devices and Radiological Health, in a statement.
The FDA reviewed results from demonstration studies with qualified radiologists under different lighting conditions. All participants agreed that the device was usable for diagnostic image interpretation under the recommended lighting conditions. However, the app is not intended to replace full workstations and is indicated for use only when there is no access to a workstation, Maisel said.
For more information on mobile data, attend these sessions at IWCE in Las Vegas, March 7-11, 2011.