On a list of Food and Drug Administration approved medical device one would expect to find items as mundane as tongue depressors alongside the latest and greatest, advanced implants. One does not expect to find an iPhone and iPad app.
And yet, FDA announced last week it approved a radiology app to assist doctors in examinations and making diagnoses. The app displays images taken from computed tomography, magnetic resonance imaging, and nuclear medicine technology, such as positron emission tomography.
“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 Dr. William Maisel, chief scientist and deputy director for science in the FDA's Center for Devices and Radiological Health.
Always HIPPA conscious to safeguard privacy, the images are distributed using a secure network. The Mobile MIM software allows physicians to measure distance, intensity values and display measurement lines, annotations and regions of interest.
FDA says it conducted several performance tests to measure screen brightness, resolution and noise. There was some concern the variation in device screen brightness would negatively affect diagnosis, but the app received approval with specific lighting instructions.
The app may significantly cut down on diagnosis time, streamline the radiology result process, and is one more step on the road to universal electronic medical records.